cms.bioaccessla.com

Author: Julio Martinez-Clark

  • Argentina Just Cut Clinical Trial Import Costs By 50 70%. Here’s What 290 Authorized Trials In 2025 Tell Founders.

    On May 19, 2026, Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) published Disposición 2978/2026, cutting import tariffs on medicines and medical devices by 50 to 70 percent, effective June 1, 2026. The preamble of the instrument states the policy goal explicitly: to attract clinical trial investment to Argentina. The next day, the Argentine government released throughput data that explained why the policy was built: 290 clinical trials authorized in 2025, a 12 percent year-over-year increase, with 114 already authorized in the first quarter of 2026 and 1,188 active studies under ANMAT supervision. Argentina is now formally branding itself an “internationally competitive clinical research hub.”

    For a Latin American clinical research operator who has spent 16 years arguing the speed-and-cost case to MedTech and biopharma founders, the May 19-20 sequence is the most unusual validation event the regulatory landscape has produced this decade. Most LATAM clinical research positioning is CRO marketing. Argentina’s came from the regulator itself, in the preamble of a binding instrument, on government letterhead, with throughput numbers attached. That is not the same kind of evidence as a competitive pitch deck.

    For founders running a 10-patient first-in-human (FIH) device study, the math now stacks in a way that materially changes the country sequencing decision. This post unpacks what changed, what stayed the same, and how founders pursuing a U.S. Early Feasibility Studies (EFS) plus out-of-U.S. (OUS) FIH strategy should think about Argentina in 2026.

    What Changed on May 19, 2026

    Disposición 2978/2026 is the binding instrument. The tariff reduction applies across the import basket relevant to clinical research operations, including investigational drugs, medical devices in trial-supply quantities, reference standards, and disposable consumables tied to study protocols. The pre-existing effective duty rate for imported medical devices in Argentina ranged from 12 to 18 percent before May 19. Under the new schedule, that effective rate compresses to roughly 6 to 12 percent for trial-supply imports, with category-specific reductions ranging from 50 to 70 percent depending on the harmonized system classification.

    On its own, the tariff cut is meaningful. It is more meaningful in combination with the operational baseline Argentina already had in place. Disposición 7516/2025, which came into force in 2025 and is fully aligned with ICH E6(R3), caps clinical trial protocol authorization at 62 calendar days (45 working days maximum). That includes parallel ethics committee review and ANMAT agency review, not sequential review. For comparison, the U.S. EFS pathway typically runs 120 to 180 days from IDE submission to first patient enrolled. Argentina’s ANMAT pathway is 60 to 120 days faster, depending on the comparison case.

    The April 24, 2026 importación simplification further compresses pre-first-patient timelines by removing roughly 14 to 21 days of customs and import-classification delay that previously sat between protocol approval and the actual arrival of study material at site. The June 1, 2026 tariff reduction now removes the cost penalty that previously sat alongside that delay.

    The Throughput Number Most Founders Miss

    The 290-trials-in-2025 figure deserves more attention than it has received. Of those 290 authorizations, the regulator-reported mix is approximately 70 percent biopharma and 30 percent medical device or combination product. The Q1 2026 pace of 114 authorizations annualizes to roughly 456 trials per year, which would represent a 57 percent year-over-year acceleration if sustained. Even if the run rate moderates by half, Argentina’s 2026 throughput will exceed all prior years on record.

    For a founder evaluating site capacity risk, the 1,188 active studies under ANMAT supervision is the more strategic data point. Argentina has the patient-volume depth and the principal-investigator network density to absorb new sponsor demand without the recruitment friction that emerging-market sites with thinner trial histories often impose. A FIH MedTech sponsor running a 10-patient study at two Argentine sites can realistically expect first-patient-in within 90 days of protocol approval, and last-patient-in within 5 to 7 months of contract execution. Those numbers have been stable across the last 36 months of bioaccess® operational experience.

    The Cost Math, Refreshed

    Pre-May 19, 2026, the LATAM per-patient cost range for a FIH MedTech study sat at $15,000 to $35,000, compared to $40,000 to $75,000 in the U.S. and Europe. For a 10-patient FIH device study, that is a $250,000 to $400,000 absolute swing, sufficient on its own to fund roughly four months of clinical operations headcount or a complete adaptive design biostatistics package.

    The June 1 tariff reduction does not move the per-patient labor cost. It moves the device and drug-import cost component, which typically represents 8 to 15 percent of total study cost for a MedTech FIH trial relying on imported investigational devices. A 50 percent reduction on that line item produces a 4 to 8 percent reduction on total study cost, which compounds with the labor cost advantage Argentina already offered. On a $250,000 study, that is an additional $10,000 to $20,000 of effective savings. On a $1 million pivotal-stage Argentine arm of a multi-country trial, the effect grows proportionally.

    The strategic value is not the headline savings number. It is the regulatory clarity that the tariff cut produces. Sponsors evaluating Argentina now know that the regulator has formally committed to clinical research as a strategic policy priority. That changes how a CFO evaluates jurisdiction risk in the IND-enabling phase.

    The Database Anomaly and How to Work Around It

    One operational caveat is worth flagging directly. ANMAT’s public pharmacology database, which historically served as the citable reference for trial throughput and status, remains anchored at a September 30, 2025 data cutoff. As of the publication date of this post, that anomaly has persisted for four consecutive weekly review cycles. The most likely explanation is a backend migration tied to the broader Argentine government’s digital transformation initiative, but the database itself does not yet reflect Q4 2025 or any 2026 data.

    For sponsors building a regulatory dossier or a board pack that requires citable Argentine clinical research throughput data, the May 20, 2026 government statistics package, available through argentina.gob.ar communications channels, is now the more authoritative source than the database. For real-time individual study status, the RENIS (Registro Nacional de Investigaciones en Salud) registry, accessible through the SISA portal, remains operative and current. Disposición 7516/25, the 62-day pathway, the importación simplification, and Disposición 2978/2026 are all fully in force regardless of the database refresh status.

    How to Sequence Argentina in a U.S. EFS Plus OUS FIH Strategy

    The most common 2026 founder question is whether to run U.S. EFS first, OUS FIH first, or both in parallel. The May 19-20 Argentina updates do not change the answer in every case, but they change it in enough cases that the question is worth re-examining.

    For structural heart, neuromodulation, and radiopharmaceutical or theranostic FIH programs, where the U.S. EFS pathway involves an IDE submission with 120 to 180 day review timelines, the parallel Argentina arm is now substantially more attractive. The argument runs as follows: a sponsor who files the IDE with FDA in month one and simultaneously files the ANMAT protocol under Disposición 7516/25 will, in a typical case, have ANMAT approval and first-patient-in achieved before the FDA has finished its initial IDE review. That bridge data, if collected against an FDA-aligned endpoint set, materially strengthens the IDE review and accelerates the post-IDE clinical trial path.

    The bridge data approach assumes the sponsor designs the Argentine arm to match the FDA-expected endpoints from the outset. That is not a regulatory obligation in Argentina, but it is the operational discipline that converts a 62-day pathway into a strategic asset rather than a parallel cost center. ICH M11 CeSHarP, finalized by ICH on May 21, 2026, makes that endpoint-aligned protocol authoring substantially more efficient than it was a year ago.

    For absorbable implants, cardiac ablation, and oncology device FIH programs, the Argentina arm makes sense as the primary FIH site set, with the U.S. EFS following as a confirmatory phase rather than as the primary first-in-human exposure. The 2026 tariff reduction further tips the math in this direction for sponsors with capital constraints between Series A and Series B.

    What This Means for the Latin American Clinical Research Landscape

    Argentina’s May 19-20 sequence is the clearest example to date of a Latin American regulator choosing, in policy, to compete for clinical research investment. Brazil, Mexico, and Colombia have made similar moves in the past 24 months, but none have packaged a binding tariff reduction with a coordinated government statistics release in the same week. The combination is what makes the Argentine moment unusual.

    For Latin American CROs, the strategic implication is that the next 12 to 18 months will likely be a sponsor-favorable market, with multiple jurisdictions actively recruiting trial volume. Sponsors who position now will benefit from regulator attention, expedited review windows, and the willingness of agencies to engage with novel trial designs at the pre-submission stage. Sponsors who delay until the policy environment has fully stabilized will lose the strategic window.

    For bioaccess® and other LATAM operators, the implication is that the value proposition has moved beyond cost and speed into regulatory partnership. The conversation a founder needs to have with their CRO in 2026 is no longer about how fast the trial can run. It is about how the trial design, the country sequence, and the data architecture combine to compress the Innovation Runway, the operational window between a founder’s first FIH decision and the data package their next funding round requires.

    The Bottom Line for Founders

    Argentina has just made the clearest policy statement any Latin American clinical research regulator has produced in 2026. The 62-day pathway under Disposición 7516/25 is operative. The importación simplification is in force. The 50 to 70 percent tariff reduction on imported medicines and medical devices begins June 1. The throughput data confirms that the regulatory environment can absorb new sponsor demand at scale.

    For a MedTech, biotech, or radiopharma founder evaluating a 2026 FIH country sequencing decision, the Argentine arm now warrants serious consideration as the lead site or the parallel site for any program where the U.S. EFS pathway is the comparison baseline. The most expensive FIH decision a founder makes is not the per-patient cost of a single study. It is the calendar cost of choosing the wrong study to run first. Argentina’s May 19-20 sequence makes the calendar argument harder to ignore.

    If you are evaluating a 2026 FIH sequencing decision and want a country-level model that reflects the new Argentina policy environment, the team at bioaccess® can produce a tailored proposal within two weeks. We have run FIH trials across Argentina, Colombia, Brazil, and Mexico since 2010, and our U.S. EFS plus LATAM FIH practice is the only one in Latin America structured to deliver both pathways under a single operational team.

    Citations:

  • First-In-Human In Brazil In 2026: A Practical Timeline For Sponsors

    First-in-Human in Brazil in 2026: A Practical Timeline for Sponsors

    Primary keyword: first-in-human trial Brazil timeline

    Brazil is increasingly on the shortlist for early-stage clinical development because sponsors can combine a large patient base with growing regulatory clarity. A recent policy analysis argued that Lei 14.874 de 2024 created the basis for a more predictable environment and, for the first time, establishes timelines and greater regulatory clarity for clinical studies.

    This article gives a practical, sponsor-side timeline for launching a first-in-human (FIH) study in Brazil in 2026—what to do first, what typically slows teams down, and how to sequence work so you do not lose weeks to preventable back-and-forth.

    1) Define the “Brazil-ready” FIH package (Weeks 0–2)

    Before any submission, align internal stakeholders on what “Brazil-ready” means. For most MedTech and biopharma sponsors, FIH readiness is not only a protocol question—it is also a documentation and site execution question.

    • Protocol and IB alignment: Ensure endpoints, safety monitoring, and dose-escalation logic are consistent with your global plan.
    • Country adaptations: Identify what must be localized or supplemented (consent language, site materials, labeling, and investigator documentation).
    • Feasibility assumptions: Confirm whether required imaging, lab, or procedural capabilities exist at target sites.

    Internal best practice: Create a single “FIH Brazil master checklist” with owners and due dates. Treat it as a deliverable, not an afterthought.

    2) Select sites for speed, not just prestige (Weeks 1–4)

    In FIH, startup speed is highly correlated with site readiness. Sponsors often choose sites based on reputation, then discover contracting and operational realities late.

    • Prioritize operational maturity: Look for sites with dedicated research staff, established ethics processes, and experience with sponsor audits.
    • Validate recruitment pathways: Treatment-naive populations can be an advantage, but referral networks still matter.
    • Assess import and handling constraints: If your study uses temperature-sensitive materials, confirm storage and chain-of-custody procedures early.

    3) Build a parallel workstream plan (Weeks 2–6)

    The most common timeline mistake is running tasks sequentially that can be executed in parallel. Even when formal review clocks improve, sequential execution can erase the benefit.

    To compress time, run these workstreams at the same time:

    • Regulatory dossier preparation (quality, safety documentation, and trial authorization package)
    • Ethics submission package (site-specific documents and consent)
    • Contracts and budgets (CTA, indemnities, payment schedules, and monitoring model)
    • Supply and logistics readiness (import planning, labeling, storage validation, and back-up scenarios)

    Even when legal reforms aim to improve predictability, sponsors still need coordinated execution across stakeholders to realize those gains.

    4) Anticipate “hidden” startup time: contracts, import, and training (Weeks 4–10)

    Even when review timelines are favorable, sponsors can lose time after approvals due to operational bottlenecks:

    • Contract negotiation cycles: Build buffer time for legal review, redlines, and institutional sign-off.
    • Import and release: If your investigational product or device must be imported, confirm lead times and documentation requirements early.
    • Site initiation and training: FIH trials require strict adherence to safety procedures; schedule training sessions while approvals are in progress.

    Practical tip: Maintain a “go-live readiness dashboard” that tracks contract status, shipment readiness, and training completion. This prevents surprises when the green light arrives.

    5) A sponsor-friendly 2026 FIH timeline (example)

    Every program is different, but a realistic planning template looks like this:

    • Weeks 0–2: Brazil-ready protocol package, checklist, and internal alignment
    • Weeks 1–4: Site selection, feasibility, and early budget/CTA drafts
    • Weeks 2–6: Parallel dossier + ethics package finalization
    • Weeks 4–10: Contracts, import planning, training, and vendor setup
    • Weeks 10–14: Final site activation steps and first-patient readiness

    If you are aiming for speed, measure time-to-ready as rigorously as you measure time-to-approval. In many FIH programs, the fastest sponsors are simply the ones that avoid rework.

    FAQ: First-in-human trial Brazil timeline

    • How long does it take to start a first-in-human trial in Brazil?
      Timelines vary by protocol complexity and site readiness, but sponsors should plan for parallel regulatory and ethics pathways, early document localization, and realistic contracting and import lead times.
    • What is the biggest cause of FIH delays in Brazil?
      In practice, delays often come from incomplete documentation, late site selection, and underestimated startup logistics (contracts, import permits, and investigational product readiness), not just the formal review clock.
    • Can Brazil FIH data support US or EU submissions?
      Yes, when the trial is designed to international GCP standards and endpoints align with your global regulatory strategy, Brazilian data can be part of a broader evidence package.

    Need help planning an FIH startup in Brazil or across Latin America? bioaccess® supports sponsors with country startup planning, site activation, and operational execution—without exposing confidential details publicly.

  • Radiopharma Trials In Latin America: Designing Operations For 6 Hour Half-Lives

    Radiopharma Trials in Latin America: Designing Operations for 6-Hour Half-Lives

    Primary keyword: radiopharmaceutical clinical trial logistics Latin America

    Radiopharmaceuticals are one of the most promising frontiers in oncology, but they force clinical teams to operate on a different clock. An industry announcement noted that because these materials decay in hours rather than months, the operational window for patient administration is extremely narrow, leaving very little margin for error.

    Latin America can be an attractive region for radiopharma development, but sponsors need an operating model that is designed for short half-lives, just-in-time supply, and site readiness. This article outlines a practical framework for radiopharmaceutical clinical trial logistics in Latin America—without duplicating country-specific checklists already covered elsewhere.

    1) Start with the “decay clock” and design backward

    Radiopharma operations should start with physics. If a product’s usable window is measured in hours, then every downstream step must be planned backwards from the scheduled administration time:

    • Manufacturing slot and release testing (including potential rework)
    • Packaging and validated temperature control
    • Transportation and customs risk (for cross-border moves)
    • Site receipt, verification, and patient preparation

    Operational principle: Do not treat shipment as a “logistics problem.” Treat it as part of the dosing procedure.

    2) Build site readiness around minute-by-minute workflows

    In many conventional trials, small workflow inefficiencies are tolerated. In radiopharma, they can cause missed windows or protocol deviations.

    • Define a standard receiving workflow: who signs, where it is stored, and how identity and activity are verified.
    • Train for exceptions: delayed flights, partial shipments, or last-minute patient rescheduling.
    • Synchronize departments: nuclear medicine, pharmacy, imaging, and the clinical team must share one operational plan.

    3) Manage supply risk with redundancy and “plan B” lanes

    A radiopharma webinar announcement highlighted just-in-time manufacturing and strict cold-chain requirements as differentiators from standard investigational products, and emphasized that protocol pivots and supply disruptions are expected rather than rare. In Latin America, the right mitigation strategies can include:

    • Backup transport lanes: pre-qualified couriers and alternate airport routing options.
    • Site network design: cluster sites to reduce travel time from production to administration.
    • Inventory philosophy: you cannot “stockpile” short half-life product, so redundancy must come from operations, not storage.

    4) A practical operating model for Latin America radiopharma programs

    To make logistics predictable, sponsors can standardize four elements across countries:

    • Readiness checklists: site staffing, equipment calibration, temperature monitoring, and emergency procedures.
    • Scheduling discipline: patient scheduling should be tied to confirmed manufacturing slots and transport windows.
    • Visibility: live tracking of manufacturing status, shipment milestones, and site receipt confirmation.
    • Contingency triggers: pre-defined thresholds for when to reschedule a patient, re-route a shipment, or activate an alternate site.

    When these elements are standardized, the operational advantage of Latin America—experienced research sites and growing infrastructure—can translate into reliable execution, not just theoretical speed.

    5) Data integrity and chain-of-custody: treat the dose as a specimen

    With radiopharmaceuticals, sponsors should document the product journey with the same rigor used for biospecimens. This reduces deviations and supports inspection readiness.

    • Time-stamped handoffs: manufacturing release, courier pickup, arrival at site, and administration time.
    • Temperature and shielding logs: continuous monitoring, out-of-range triggers, and documented corrective actions.
    • Identity checks: verify patient, product label, and activity at the moment of administration.

    Practical tip: Create a single-page “dose administration record” that sites can complete in real time and upload the same day.

    6) Regulatory and customs planning: design for border reality

    Latin America is not one regulatory system. Cross-border moves can introduce unpredictable delays, so logistics planning should assume variability and reduce exposure wherever possible.

    • Prefer in-country or near-country production when feasible: shorter transit times reduce decay loss.
    • Pre-clear documentation: align on import documentation, labeling, and receiver information well before first shipment.
    • Schedule around local constraints: weekends, holidays, and airport cutoffs matter more when the product lifetime is measured in hours.

    When sponsors plan for these constraints, Latin America sites can deliver high-quality execution even for time-sensitive protocols.

    FAQ: Radiopharmaceutical clinical trial logistics Latin America

    • Why are radiopharmaceutical trials harder to run than conventional trials?
      Because many products decay in hours, the operational window is extremely narrow and sites must coordinate manufacturing, shipping, and patient readiness with little margin for error.
    • What is the most common operational failure mode?
      Missed administration windows caused by delays in manufacturing release, transportation, site workflow issues, or patient no-shows.
    • How can Latin America sites reduce missed dosing windows?
      By building standardized readiness checklists, aligning patient scheduling with shipment timelines, and designing contingency plans for transportation or manufacturing disruptions.

    Planning a radiopharma study in Latin America? bioaccess® can help sponsors design site networks, readiness plans, and startup execution models that reduce missed dosing windows.

  • COFEPRIS Just Made Clinical Research Approval Simpler In Mexico. Here’s What Changed.






    COFEPRIS Just Made Clinical Research Approval Simpler in Mexico. Here’s What Changed.


    COFEPRIS Just Made Clinical Research Approval Simpler in Mexico. Here’s What Changed.

    Published: May 18, 2026 | bioaccess® Research and Regulatory Team

    The Acuerdo and Its Limits

    On May 4, 2026, Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios published a Diario Oficial de la Federación Acuerdo that took effect two days later, on May 6. The Acuerdo formalized mandatory digital submission of all clinical research protocols through DIGIPRiS — COFEPRIS’s electronic platform — and introduced an exemption category that removes the authorization requirement entirely for a defined class of low-risk studies. The headline reads as regulatory modernization. For a first-in-human founder evaluating Mexico as a clinical site, the reality is more textured than the headline suggests.

    Mexico has long held structural advantages for clinical research that its regulatory timeline has historically undercut. It is the second-largest pharmaceutical market in Latin America. Its urban research sites in Mexico City and Monterrey are well-staffed and experienced. The patient population for therapeutic categories ranging from urology to metabolic disease is large. What founders and regulatory directors have historically encountered is a submission process that, by COFEPRIS’s own published data, averaged up to 400 days for clinical trial approval before the current modernization wave began.

    The May 4 Acuerdo does not eliminate that history overnight. It signals a directional change — one that is already showing measurable effects in the data — and it introduces two specific operational shifts that matter more than the general narrative of “faster approvals”: a mandatory digital platform with concrete submission requirements, and an exemption classification that most non-Mexico-specialist CROs do not surface for their clients. Understanding both is how founders use this moment rather than simply noting it.

    bioaccess® has operated across 10 Latin American countries since 2010, supporting 58 client companies through first-in-human programs. This post draws on that operational context to translate the Acuerdo from regulatory text into a practical framework for founders and regulatory affairs directors building or revising their LATAM clinical strategy.

    What the Acuerdo Actually Changed

    The May 4 DOF Acuerdo, published at sidof.segob.gob.mx/notas/5786604, mandates three operational shifts:

    • DIGIPRiS is now the mandatory submission channel for all new clinical research protocols. Sponsors and CROs must submit new protocols, amendments, and technical reports exclusively through the DIGIPRiS portal. Legacy paper-based filing pathways are no longer accepted for new submissions. This applies regardless of study phase, therapeutic category, or sponsor geography. An active institutional account with delegated user roles — authorizer, editor, viewer — must be established before any submission clock starts. First-time submitters without existing platform credentials should allow 2–4 weeks for account setup and role delegation before protocol review begins.
    • “Investigación sin riesgo” studies are fully exempt from COFEPRIS authorization. Mexico’s health research regulatory framework (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud) classifies research into risk tiers. “Investigación sin riesgo” — no-risk research — covers studies that use documentary techniques, structured interviews, observation, and non-invasive physiological measurement without procedures that exceed standard clinical contact. Studies in this category do not require COFEPRIS authorization under the Acuerdo and do not submit through DIGIPRiS for authorization purposes. Device sponsors developing companion diagnostics, observational registries, or instrument-only studies should determine whether their study qualifies before assuming full COFEPRIS submission overhead. Misclassification in either direction costs time.
    • Single-opportunity prevention and immediate resolution schemes. The Acuerdo introduces a single-opportunity rule for submission completeness — incomplete dossiers are flagged at intake rather than returned weeks into the review cycle. For defined categories, immediate resolution pathways are introduced. Both changes are designed to reduce the back-and-forth that historically inflated review timelines well beyond regulatory normatives.

    Prior to the Acuerdo, DIGIPRiS had been in partial rollout since 2025. As of May 2026, the platform manages 90% of protocol amendment workflows. The transition to mandatory full-protocol submission through the same channel completes that digital migration. For CROs and sponsors with established accounts, this is an efficiency gain. For those entering Mexico for the first time, platform credentialing is now a prerequisite step, not a parallel task.

    The 400-Day Baseline: What the Data Actually Says

    Any accurate assessment of the Acuerdo’s significance requires anchoring in the numbers COFEPRIS itself has published. The agency’s Digitalización 2026 Plan — a 60-million-peso initiative with a December 2026 completion target, surfaced in mid-May 2026 — explicitly acknowledges that historical clinical trial approval times averaged up to 400 days prior to the current modernization wave. That number is not an advocacy figure. It is the baseline COFEPRIS used to set its own performance improvement targets.

    Against that baseline, the 2025 DIGIPRiS implementation data is meaningful: average protocol approval times dropped from 90 to 45 calendar days between January and April 2025 as the platform was progressively deployed. Amendment reviews averaged 57 days — a 37% improvement over prior normatives. By May 2026, the platform manages 90% of amendment workflows. These numbers reflect a partial rollout; the full mandatory deployment that began May 6 will produce new performance data over the coming quarters.

    The honest framing for a founder: the Acuerdo signals structural intent backed by published data. It does not transform Mexico’s regulatory environment overnight. Budget conservatively on timeline while treating the directional improvement as real. For programs that can align protocol submission with a Mexico study start, the compression from 90 to 45 days — let alone from 400 — is structurally significant.

    The Fastest Route: COFEPRIS Reliance for Reference-Authority Protocols

    For sponsors whose protocols have already received authorization from a WHO-recognized high-level regulatory authority — including the FDA, EMA, or MHRA — the fastest Mexico submission route is not the standard DIGIPRiS pathway. It is the COFEPRIS reliance mechanism published in the Diario Oficial de la Federación on March 24, 2025, as analyzed by Global Regulatory Partners.

    Under the reliance framework, protocols already authorized by reference regulators receive an abbreviated COFEPRIS review with target timelines of:

    • 30 business days for medical devices
    • 45 business days for drugs and biologics

    These timelines are not guarantees — they are regulatory normatives. But for a device sponsor who has already completed an FDA Early Feasibility Study, or whose protocol carries CE mark approval, the reliance pathway represents a materially faster entry than standard review. DIGIPRiS makes the submission process for reliance applications cleaner and more trackable than the legacy paper system.

    The practical implication: device founders should confirm whether their existing FDA or EMA documentation qualifies their Mexico protocol for the reliance pathway before defaulting to standard submission. The 30-business-day target for devices under reliance — approximately six calendar weeks — positions Mexico competitively with other LATAM FIH markets when this pathway applies.

    For sponsors evaluating Mexico as part of a U.S.-plus-LATAM clinical strategy, the reliance pathway and the standard DIGIPRiS route serve different program types. Reliance is the right tool for sponsors with prior reference-authority approval. DIGIPRiS standard review is the route for novel protocols. Knowing which applies to your study at the outset determines whether Mexico belongs in your Year 1 clinical plan or your Year 2.

    Where Mexico Fits in a LATAM Clinical Portfolio

    Mexico’s regulatory position in the LATAM FIH landscape is distinct from its regional peers. A direct comparison helps founders understand where Mexico fits in a multi-country program design.

    Country Regulatory Authority Target Review Timeline Fastest Ethics Timeline Key Pathway Feature
    Colombia INVIMA ~30 days (authority) 15–18 days (bioaccess®-managed) Fastest FIH ethics timeline in LATAM; strong site density
    Mexico COFEPRIS 30 BD (devices, reliance) / 45 BD (drugs, reliance) / 45 CD (standard DIGIPRiS) 4–8 weeks (typical) Reliance pathway for FDA/EMA-approved protocols; second-largest LATAM pharma market
    Brazil ANVISA 90 days (parallel review, RDC 945/2024) Concurrent with ANVISA review Parallel ethics and authority review; largest LATAM market by patient volume
    Argentina ANMAT 62 days (Disposición 7516/2025) Concurrent with ANMAT review Streamlined 62-day normative; strong oncology and metabolic disease site base

    Colombia remains the fastest LATAM jurisdiction for first-in-human medical device studies on a combined authority-plus-ethics basis. For sponsors whose primary objective is speed to FIH data, Colombia typically anchors the program.

    Mexico’s distinct value is patient population size, strong research sites in Mexico City and Monterrey, and — post-Acuerdo — a materially improved submission process for both standard and reliance pathways. It is not the fastest LATAM market, but it is increasingly competitive for sponsors requiring large patient pools, FDA/EMA-eligible reliance, or a Mexico regulatory track record for commercial purposes. For a multi-country program — Colombia for FIH speed, Mexico for expanded cohort enrollment — the post-Acuerdo improvement changes the sequencing calculus.

    What Founders Should Do Now

    If Mexico is in your clinical plan for 2026 or 2027, three actions should happen before your next protocol submission discussion:

    • Establish DIGIPRiS credentialing immediately. The platform requires institutional account setup, user role delegation, and CRO authorization documentation. This is not a same-day process. For sponsors working with a CRO that already holds active DIGIPRiS credentials, this step is absorbed into existing infrastructure. For sponsors engaging a CRO for the first time, confirm credential status before the contract is signed. A CRO without an active account adds 2–4 weeks before your protocol review clock starts — time that has nothing to do with the regulatory review itself.
    • Determine if your study qualifies as “investigación sin riesgo.” Sponsors developing observational registries, companion diagnostics, or non-invasive measurement instruments should review their study design against the risk classification framework before assuming full COFEPRIS submission overhead. A regulatory classification confirmation at protocol design stage is a 2–3 day exercise. Misclassification costs 4–8 weeks.
    • Confirm your protocol’s reliance eligibility. If your study has received FDA or EMA authorization, the reliance pathway targets 30 business days for devices and 45 business days for drugs. This is the fastest available COFEPRIS review track and requires specific documentation at submission. DIGIPRiS submission under the reliance pathway follows the same platform process as standard review but with a different regulatory dossier structure. Confirm reliance eligibility and documentation requirements with your CRO before drafting the submission package.

    Navigating DIGIPRiS requires an institutional account with established COFEPRIS relationships, documented sponsor delegation, and a track record of dossier completeness under the single-opportunity rule. A first-time submitter absorbs the platform learning curve on your protocol’s timeline. A CRO with active Mexico credentials absorbs it before your protocol arrives.

    Three Questions to Determine Whether Mexico Belongs in Your 2026 Clinical Plan

    The Acuerdo doesn’t change the fundamental logic of LATAM site selection for FIH programs. It changes one variable — submission timeline and process — in a direction that favors Mexico more than the previous two years did. The three questions that determine whether that change is material for your program:

    1. Does your protocol have FDA, EMA, or MHRA authorization? If yes, the COFEPRIS reliance pathway positions Mexico’s device review at 30 business days — competitive with Colombia on a combined basis for sponsors who don’t need ultra-fast ethics timelines. If no, standard DIGIPRiS review timelines apply and Colombia likely leads on speed.
    2. Does your primary endpoint require a large patient pool that a single Colombia site cannot support? Mexico’s site density in Mexico City and Monterrey, combined with the post-Acuerdo submission improvement, makes Mexico a natural partner for expanded cohort enrollment in programs that opened in Colombia. For sponsors needing 30–50+ patients in a single FIH program, a Colombia-plus-Mexico multi-site design may be the right structure.
    3. Is Mexico a target commercial market? If your device’s commercial path includes Mexico — a market of 130 million people with a growing private healthcare sector — building a Mexico regulatory track record at FIH stage is not just a trial design question. It is a commercial infrastructure question. The DIGIPRiS improvement makes it less costly to establish that track record early.

    If you answer yes to any of these three questions, Mexico belongs in your 2026–2027 clinical planning discussion. The Acuerdo gave it a better position on the board than it held twelve months ago.

    Next Steps

    If you are evaluating Mexico as part of a LATAM FIH or multi-country clinical program, the time to establish DIGIPRiS infrastructure and confirm your study’s regulatory classification is before your protocol is finalized — not after. The window where Mexico’s post-Acuerdo momentum aligns with available site capacity and a CRO team already credentialed on the platform is now.

    Book a meeting to discuss where Mexico fits in your clinical strategy, or use the clinical trial cost calculator to model per-patient and total program costs across LATAM jurisdictions.

    Sources


  • Proyecto de Ley 191 de 2025: una oportunidad histórica para la investigación clínica en Colombia

    Proyecto de Ley 191 de 2025: una oportunidad histórica para la investigación clínica en Colombia

    El pasado 7 de mayo de 2026, asistí como presidente de la Asociación Latinoamericana de Comités de Ética en Investigación Clínica (ALCEIC) a la audiencia pública convocada por la Comisión Séptima Constitucional Permanente de la Cámara de Representantes del Congreso de la República, en la que se adelantó la discusión del Proyecto de Ley 191 de 2025, iniciativa que busca establecer el marco regulatorio integral para la investigación clínica con seres humanos en Colombia.

    Siete meses después: un texto más maduro y concertado

    El pasado 20 de octubre, en el marco de la primera audiencia pública convocada por la Comisión Séptima de la Cámara de Representantes, se realizó un primer debate del Proyecto de Ley 191 de 2025 que busca regular la investigación clínica en Colombia. Después de una ardua sesión, en la que se presentaron distintos puntos de vista frente a la iniciativa, una de las principales conclusiones fue clara: esta es una gran oportunidad para que el país cuente con una legislación actualizada que responda a las necesidades del sistema de salud y, en especial, a las necesidades de los pacientes.

    Han pasado siete meses desde aquel primer debate. Durante este período, los distintos actores del ecosistema —desde su misión y su visión particular— han venido revisando el proyecto, actualizando su contenido y ajustándolo a las observaciones realizadas en esa primera audiencia. El texto que llegó a la sesión del 7 de mayo es, por tanto, un texto más maduro, más concertado y mejor alineado con las realidades del país.

    ¿Qué le aportaría al país una Ley de Investigación Clínica?

    En estos momentos, en los que nos encontramos inmersos en un mundo globalizado y en los que la investigación clínica constituye un área estratégica para Colombia, es legítimo preguntarse qué aportaría una ley de este tipo al desarrollo y fortalecimiento de nuestro ecosistema. Entre los principales aportes encontramos los siguientes:

    • Facilita la innovación.
    • Genera beneficios concretos para los pacientes, quienes tendrían acceso a tratamientos innovadores antes y de manera más equitativa.
    • Es una fuente de generación de empleos, en especial de personal altamente calificado.
    • Permite mejorar la calidad de las instituciones públicas y privadas que participan en el ecosistema.
    • Genera networking con países desarrollados, lo que favorece la competitividad y permite que Colombia participe en estudios clínicos multicéntricos de fase tardía y temprana, acercándonos a la frontera de la innovación.

    Argentina y Brasil entendieron esto rápidamente e implementaron un marco regulatorio que permitió comenzar de manera ágil el reclutamiento de pacientes. Nosotros no podemos seguir esperando.

    La lección de México: propiedad intelectual como motor

    En el caso mexicano, el país avanza en esa dirección con la implementación del T-MEC y el Plan México. El sector farmacéutico salva la vida de miles de mexicanos y la protección de la propiedad industrial es el motor de esa iniciativa, ya que garantiza la inversión en biotecnología y medicina.

    La industria farmacéutica tiene una gran capacidad de generar empleos y se ha planteado la meta de atraer 2.000 millones de dólares de inversión en el sector. Pero para alcanzar esas metas se requiere una mayor agilidad en la aprobación de los ensayos clínicos. Por eso la Cofepris, agencia regulatoria mexicana, se ha fijado como meta aprobarlos en un plazo no mayor a 40 días, además de la expansión de la infraestructura y de los estímulos fiscales para incentivar la investigación.

    La innovación generada en México requiere un marco legal centrado en la propiedad intelectual. Y México presenta varias ventajas comparativas frente a otros países de la región:

    • Una población de gran tamaño y con una amplia diversidad genética.
    • Un perfil epidemiológico similar al de otros países del hemisferio norte —cáncer, enfermedades cardiovasculares, obesidad y diabetes—, lo que la convierte en un sitio estratégico para desarrollar ensayos clínicos.
    • Una posición geográfica estratégica como puente natural entre Estados Unidos y Latinoamérica, que les permite centrar y coordinar políticas públicas que los consoliden como región frente a un entorno altamente competitivo.
    • Una capacidad humana y física con centros de investigación y hospitales especializados.
    • Un marco normativo en mejora constante que da las garantías necesarias para que la inversión pueda generarse, en especial mediante medidas dirigidas a la protección de la propiedad intelectual: protección de patentes, protección extensiva, exclusividad, mecanismos ágiles para el otorgamiento de patentes y mecanismos de seguimiento.

    En este sentido, el Estado juega un rol fundamental, dado que es el garante de que la legislación se cumpla. Esta legislación, además, debe estar armonizada con la normativa internacional, generando confianza y facilitando la transferencia tecnológica. Cuando existen mecanismos claros de protección de los activos intelectuales, la inversión llega.

    Por eso considero que el sector privado y la academia tienen el papel de impulsar políticas públicas que vayan más allá del gobierno de turno y que coloquen a la propiedad intelectual en el centro del desarrollo económico y de la inversión en los distintos países.

    Qué debe contener la Ley colombiana

    Con base en lo anterior, en el caso de Colombia, una Ley de Ensayos Clínicos debe estar centrada, además de en los pacientes, en la innovación como motor de generación de capital en ciencia, tecnología e innovación, tanto a nivel local como nacional o regional. Asimismo, debe centrarse en la resolución de las necesidades sentidas de la población, en especial de las poblaciones vulnerables, como ocurre con las enfermedades huérfanas.

    Desde el punto de vista económico, contar con una Ley de Ensayos Clínicos permitirá el acceso a nuevos tratamientos, reducirá la brecha de accesibilidad y permitirá una mayor equidad y cobertura para el bienestar de los pacientes. Esto se traduce en un alto impacto en el bienestar colectivo de la población colombiana.

    Epidemiológicamente, tenemos la población y tenemos la experiencia. Lo que necesitamos es un andamiaje jurídico que permita agilizar los procesos para que Colombia sea considerado un país de primera elección por la industria farmacéutica. Este proceso, a su vez, impulsa el desarrollo de la industria nacional a partir de la infraestructura ya existente. La innovación es un catalizador del desarrollo económico y social: en la revisión del T-MEC, la propiedad intelectual ocupa un papel preponderante, porque permite el respeto a los datos, su registro y la utilización de herramientas como la inteligencia artificial.

    Un marco regulatorio que genere confianza

    Contar con una Ley de Investigación Clínica proporciona un marco regulatorio y ético que da claridad a los patrocinadores, a las organizaciones de investigación por contrato (CRO), a las organizaciones de gestión del sitio (SMO), a los centros de investigación, a los investigadores y a los comités de ética en investigación clínica (CEIC). Define las responsabilidades de cada actor del ecosistema y, con ello, genera un escenario de transparencia y de confianza pública.

    Cuando el ecosistema funciona con confianza —y muy en especial cuando protege a los pacientes—, se definen estándares éticos claros, se delimita la mala praxis, se facilita la participación de los pacientes y aumenta la inversión, porque las compañías cuentan con reglas claras en materia de propiedad intelectual y de protección de datos. Esto repercute en la calidad de la evidencia que generamos, en publicaciones de mayor impacto y en el reconocimiento internacional de Colombia como un país que cuenta con un instrumento que protege a los pacientes.

    La base jurídica del ecosistema de investigación clínica, bajo un marco regulatorio estricto, brinda seguridad a los centros de investigación y a los investigadores y permite que el trabajo se realice de manera uniforme, sin subjetividades y centrado en los participantes. Le corresponde al Estado el deber de vigilar la protección jurídica tanto de los participantes como de sus familias por causa de los estudios clínicos.

    La Ley debe contemplar reglas claras para todos los actores, para que estén en pleno conocimiento de las sanciones a las que se exponen cuando no cumplan con lo normado. También debe establecer que los derechos de los pacientes sean diáfanos y que se adhieran a principios universales, como la Declaración de Helsinki y las Normas ICH.

    El rol de los Comités de Ética (CEIC)

    En el caso de los CEIC, estos se constituyen como garantes de la protección de los sujetos que participan en un ensayo clínico. Por ello, sus miembros deben tener una sólida formación en:

    • Los principios bioéticos y su aplicación práctica.
    • La regulación tanto local como internacional.
    • La metodología de la investigación clínica.
    • La evaluación riesgo/beneficio, en especial frente a poblaciones vulnerables.
    • El consentimiento informado.
    • El manejo de bases de datos, incluidos los datos del mundo real (real-world data).

    Mesa Nacional, Foro CELAC–África y un horizonte regional

    Finalmente, deseo resaltar el trabajo que hemos venido realizando en la Mesa Nacional en Investigación Clínica liderada por el Invima, en la que a lo largo de estos meses se ha venido trabajando, de manera concertada, en una nueva propuesta del proyecto, destacando la participación de los distintos actores del ecosistema y, muy en especial, de los representantes de los pacientes.

    En este mismo sentido, deseo destacar los resultados del Foro de Alto Nivel CELAC–África, celebrado en Bogotá entre el 18 y el 21 de marzo pasado. En él se propuso que la base de la cooperación entre la CELAC y la Unión de Naciones Africanas debe estar centrada en tres pilares fundamentales: la colaboración técnica, el compromiso político y la existencia de marcos legales sólidos.

    Estos tres pilares permiten desarrollar mecanismos de confianza como procesos graduales que requieren la participación activa de los países y una adecuada adaptación a las realidades nacionales. Todo ello derivará en procesos de integración y convergencia regulatoria que fortalecerán los mercados farmacéuticos, ampliarán el acceso, consolidarán la producción local de medicamentos, harán posibles evaluaciones conjuntas y articularán a los diferentes actores del sector salud.

    De ahí la importancia de que Colombia cuente con una sólida Ley de Ensayos Clínicos que constituya un pilar más en el avance hacia la firma de un Memorando de Entendimiento entre el Invima y la Agencia de Desarrollo de la Unión Africana (AUDA-NEPAD).

    Una invitación final

    Colombia tiene la población, la experiencia, los centros certificados en Buenas Prácticas Clínicas y un talento humano comprobado. Lo que necesitamos hoy es un marco legal moderno, predecible y armonizado con los estándares internacionales. El Proyecto de Ley 191 de 2025 representa una oportunidad histórica para responder a las necesidades de los pacientes, fortalecer la innovación y posicionar al país como destino de primera elección en investigación clínica de la región.

    Mi invitación, como presidente de ALCEIC y como bioeticista, es a que sigamos trabajando de manera concertada, con los pacientes en el centro y con la mirada puesta en una Colombia que produce, atrae y protege la investigación clínica de la más alta calidad.

    Muchas gracias.

    Sobre el autor: El Dr. Luis Gustavo Celis Regalado es Magíster en Biología con énfasis en Genética Humana de la Universidad de los Andes y especialista en Bioética por la Universidad de La Sabana. Es profesor de la Facultad de Medicina de la Universidad de La Sabana, presidente del Comité de Bioética en Investigación Clínica de la misma institución y presidente de la Asociación Latinoamericana de Comités de Ética en Investigación Clínica (ALCEIC).

  • 5 Questions Every MedTech Team Asks Before Running Their First-in-Human Trial in Latin America

    On May 8, 2026, 98 MedTech professionals from 17 countries joined our Friday In Focus webinar on running first-in-human (FIH) clinical trials in Latin America. 59% stayed past 46 minutes in a 62-minute session — and they didn’t ask curiosity questions. They asked execution questions: country selection, ethics, FDA acceptability, statistical power, step-by-step playbooks for medical device sponsors who are actively planning their first FIH outside the United States.

    If you’re evaluating whether to run your next first-in-human study in Latin America, here are the five questions your peers pushed hardest on — and how to think about each one before you commit to a country, an ethics committee, or an FDA submission strategy.

    1. Which country in Latin America is the easiest?

    This was the first question out of the gate, asked by Rocío Paublete (Sweden, PMCF & Clinical Investigation Project Manager) and echoed throughout the chat. The honest answer is: it depends on what you’re optimizing for.

    “Easy” decomposes into three orthogonal dimensions:

    • Patient recruitment speed — how quickly you can enroll the first 5–30 patients for an FIH or early feasibility study. Colombia, Mexico, and Brazil typically lead here because of dense urban hospital networks and high physician engagement with research.
    • Ethics committee turnaround — how long the IRB/CEI review cycle takes from submission to approval. Chile and Costa Rica run faster review cycles than Brazil, where amendments through CONEP can stretch.
    • Regulatory authority predictability — INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), DIGEMID (Peru), and ISP (Chile) all have different timelines, fee structures, and documentation expectations.

    For most US-headquartered MedTech sponsors running an FIH, the practical sweet spot is Colombia or Costa Rica for first-patient-in speed, with Brazil considered when the indication requires larger patient diversity or when the eventual commercial path runs through Latin America’s largest market.

    2. Are those countries easier because of recruitment, or because of ethics committees?

    Rocío came back with this follow-up — and it’s the right one to ask. The two drivers behave differently:

    • Recruitment speed is largely a function of investigator network density, hospital infrastructure, and patient population. It’s a relatively stable property of the country and the indication.
    • Ethics committee speed varies by which committee, not just which country. A Bogotá-based academic medical center’s CEI may turn around in 4–6 weeks; a regional committee might take 12. The same country can deliver dramatically different timelines depending on site selection.

    The implication for sponsors: pick countries where both the recruitment and the committee math work, then pick sites where you’ve already mapped CEI cycle times empirically. Don’t optimize one without the other.

    3. Will the FDA accept clinical data generated in Latin America?

    This question, from Bhavik Gondaliya (Germany, RA), is the one that gates every conversation about whether LatAm FIH data will actually contribute to a US regulatory submission. The short answer: yes, with conditions.

    The FDA’s longstanding position on foreign clinical data is codified in 21 CFR 814.15 for PMA submissions and reflected in their 2018 guidance “Acceptance of Clinical Data to Support Medical Device Applications and Submissions.” LatAm data is acceptable if:

    • The study was conducted in accordance with Good Clinical Practice (GCP), including independent ethics review and informed consent
    • The data are applicable to the US patient population (the FDA looks for population overlap on the relevant clinical and demographic axes)
    • The site investigators were qualified, the protocol was scientifically sound, and the data are auditable by FDA inspectors

    For most early-stage MedTech sponsors, the practical playbook is to design the LatAm FIH so that its protocol, endpoints, and case report forms look like what an FDA reviewer would expect to see in a US pivotal study. Doing this work upfront makes the eventual bridging to a US IDE or 510(k)/De Novo dramatically smoother.

    4. How do you handle the ethics of providing investigational therapy “for free” in lower-resource settings?

    Nyerngoor Korda Hewitt (UK, Director of Regulatory Affairs and Quality) raised this — and it’s a question every sponsor should be ready for. The concern is real: when an FIH protocol provides expensive investigational therapy at no cost in a country where standard care is often unaffordable, you can create undue inducement.

    The frameworks that govern this are well-established — the Declaration of Helsinki (especially Articles 19–20 on vulnerable populations), the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and country-specific implementations. Operationally, robust sponsors design their LatAm FIH protocols to address inducement directly:

    • Post-trial access — explicit commitments about whether participants will continue to receive the therapy after the trial ends, and under what conditions
    • Standard-of-care arms — when ethically and statistically appropriate, designing comparator arms so participants aren’t forced to choose between trial enrollment and accessible care
    • Independent ethics review in the host country, with documented review of the inducement question by the local CEI
    • Community engagement — particularly for indications where the trial may shape future access in the country

    The audience response on this question made clear: it’s a topic experienced sponsors and their RA teams take seriously, and one ethics committees in Colombia, Mexico, Chile, and elsewhere actively probe.

    5. Step-by-step: I have a de novo medical device and I want to do FIH in Panama or Bolivia. What does it actually look like?

    This question, from Joseph Skraba (University of Texas at Austin, Manager of Medical Device Commercialization), was the most operational of the session. Here’s the compressed playbook for a de novo Class II/III medical device sponsor:

    1. Pre-clinical foundation — bench testing, biocompatibility (ISO 10993), sterilization validation, and animal study data sufficient to support first human exposure. This is non-negotiable.
    2. FDA pre-submission (Q-Sub) is optional but strongly recommended — even for studies conducted entirely outside the US, a Q-Sub conversation aligns the FDA’s expectations for how the foreign data will support a future US submission. This is “free insurance” for your eventual regulatory path.
    3. Export approval — for a non-US-cleared device, you’ll need an FDA Export Certificate (typically a Certificate to Foreign Government, CFG) under Section 801(e) of the FD&C Act. Lead time is usually 4–6 weeks.
    4. In-country regulatory approval — country-specific medical device authorization. INVIMA (Colombia) and ANMAT (Argentina) have streamlined pathways for clinical investigation devices; smaller markets like Panama and Bolivia rely on Ministry of Health approvals that vary in predictability. Plan 8–16 weeks.
    5. Ethics committee review — single-site or multi-site CEI approval. Allow 4–12 weeks depending on country and committee. Many sponsors run this in parallel with regulatory.
    6. Site activation — investigator agreements, indemnification (and clinical trial insurance — required in most LatAm countries), training on the IFU and protocol, IRT/EDC system rollout.
    7. First-patient-in — typically 6–9 months from kickoff for a well-prepared sponsor, faster with an experienced in-country CRO.

    The realistic end-to-end timeline from contracting to first-patient-in is 6–9 months for sponsors who arrive prepared, longer for sponsors who try to compress pre-clinical or skip the FDA Q-Sub.

    Bonus: “Statistical power with 5 patients?”

    Stephanie Grassmann (Switzerland, MedTechXperts LLC) lobbed this one in — and the answer is: FIH studies aren’t powered for inferential statistics, and that’s by design.

    An FIH/early-feasibility study (typically 5–30 patients) is designed to evaluate safety, device handling, procedural success, and preliminary signals of efficacy. The endpoints are descriptive: rates, intervals, mean changes from baseline. The next study (pilot or pivotal, often 50–300+ patients) is where powered hypothesis testing begins. The two studies serve different scientific purposes and are evaluated by the FDA on different criteria.

    For sponsors evaluating whether their LatAm FIH will “count” toward their eventual US submission: it counts if it answers the questions a 5–30 patient study is designed to answer. Don’t try to make it carry weight it wasn’t designed to bear.

    Who was in the room

    The 98 attendees came from 17 countries across North America, Europe, Latin America, and Asia, with roles ranging from Regulatory Affairs leaders and Quality directors to MedTech founders and CEOs. The session ran from 11:00 AM to 12:02 PM ET on Friday, May 8, 2026, and 20% of listeners stayed for the final two minutes — an engagement signal that tracks with the seriousness of the questions asked.

    Next steps for your team

    If your team is actively planning a first-in-human study and wrestling with any of the questions above, here’s how to move forward:

    • Free 30-minute feasibility screen — share your indication, target patient count, and target FPI date, and we’ll tell you which 2–3 LatAm countries are realistic for your specific case. Book a call →
    • Read the case studies — bioaccess® has supported FIH and early-feasibility studies for cardiology, neurology, ophthalmology, and orthopedic device sponsors across Colombia, Mexico, Chile, Costa Rica, and Brazil. See recent case studies →
    • Stay current — we publish new analyses of LatAm regulatory shifts (ANVISA’s 2026–2027 international convergence agenda, FDA’s December 2025 RWE guidance and what it means for LatAm data, ophthalmic FIH dynamics in smaller markets) every week. Subscribe via the form below.

    Thanks to the 98 MedTech professionals who joined the session, and to the panelists and moderators who made the depth of the discussion possible. The next Friday In Focus session will be announced shortly.

  • How To Read A CRO Capability Deck Like A Regulator (What The Marketing Doesn’t Say)






    How to Read a CRO Capability Deck Like a Regulator (What the Marketing Doesn’t Say)


    How to Read a CRO Capability Deck Like a Regulator (What the Marketing Doesn’t Say)

    Published May 11, 2026 | bioaccess®®

    You have $8 million in runway, a novel cardiac device, and a 10-patient first-in-human study to execute before your Series A conversation begins. A CRO has just sent you a 40-slide capability deck. The deck opens with a world map covered in pins. It lists therapeutic area expertise across oncology, cardiology, and neurology. It has a slide on “integrated Phase 1–4 capabilities” and another on “global QMS infrastructure.” It closes with a client testimonial from a pharma sponsor who ran a 200-site Phase 3 program.

    The deck is professionally produced and factually accurate. It is also almost entirely uninformative for your decision.

    Read it the way an FDA reviewer reads an IND submission: with a deliberate bias toward what is absent, not what is highlighted. A well-constructed IND foregrounds safety rationale, device description, and study design. A skilled reviewer immediately turns to what is omitted — the gaps in the risk analysis, the unstated assumptions in the device description, the absence of site-specific data. The omissions are where the decision lives.

    CRO capability decks follow the same logic in reverse. They are built to foreground strengths and suppress comparative weaknesses. For a founder making a CRO selection at the most consequential stage of clinical development — the first-in-human study — the standard capability deck is an exercise in strategic omission. This post identifies what to look for in the gaps.

    The “Risk-Reduction Partner” Tell

    In May 2026, ERGOMED ran a session at OCT Europe in Barcelona titled “Reframing the CRO: From Vendor to Risk-Reduction Partner.” The session is worth examining not as a critique of ERGOMED — it is a thoughtful positioning move for their target market — but as a diagnostic tool for understanding how full-service CROs think about their value proposition.

    “Risk-reduction partner” is Phase 3 enterprise vocabulary. In the context it is designed for, it is entirely appropriate. Sponsors running 200-site global oncology programs have a legitimate problem: execution risk at scale. The CRO’s job in that world is to absorb institutional complexity, manage deviation escalation across jurisdictions, and maintain data quality across a program that may run five years and involve hundreds of investigators. “Risk-reduction partner” accurately describes what those sponsors need.

    A MedTech founder with $8 million in runway and a 10-patient first-in-human study does not have that problem. The founder’s risk is not execution complexity. It is time-to-data and capital burn before the Series A window. Those are structurally different problems, and they require structurally different operational models.

    When a CRO’s conference positioning, capability deck language, and testimonial library are uniformly oriented toward large pharma sponsors managing late-phase complexity, that is a tell. The CRO has built its systems, its hiring model, its regulatory relationships, and its project management infrastructure for that world. When a FIH-focused MedTech founder engages that CRO, they are not in the wrong room — they are in a room designed for a different problem. The capability deck will not surface this distinction, because the CRO has no incentive to name it. The founder has to read it out of the omissions.

    The question is not whether a CRO is good at what it does. The question is whether what it does is what you need.

    What Gets Emphasized vs. What Gets Omitted

    CRO capability decks are designed by marketing and business development teams. They foreground what differentiates the firm in competitive presentations to late-phase sponsors, because that is the primary audience most CROs are selling to. When you receive one as a FIH MedTech founder, you are reading a document optimized for a different buyer.

    What is consistently foregrounded:

    • Integrated Phase 1–4 capability (breadth signals institutional scale)
    • Global site footprint (pin maps create an impression of reach)
    • Late-phase QMS infrastructure (relevant to sponsors managing multi-site Phase 3 programs)
    • Therapeutic area expertise in high-revenue categories (oncology, CNS, rare disease)
    • Client testimonials from pharma sponsors, typically Phase 2–3 programs

    What is systematically omitted:

    • Per-patient cost ranges at the FIH stage. Capability decks price by service line, not by patient. A 10-patient FIH study in the United States or EU runs approximately $40,000–$75,000 per patient at comparable Latin American sites, the same study costs $15,000–$35,000. That is a $250,000–$400,000 difference on a 10-patient program. No capability deck will surface this unprompted.
    • Jurisdiction-specific approval timelines. U.S. academic IRBs average 6.5 months for initial review of a novel device protocol. That number does not appear in any capability deck from a CRO built on U.S. site infrastructure, because it is not a competitive advantage for them. It should be the first number you ask for.
    • The percentage of active portfolio that is first-in-human. A CRO that is 90% concentrated in Phase 2–4 programs has built its project management systems, its site relationships, and its hiring model for that concentration. Ask for the actual number.

    Reading a capability deck as a regulator reads an IND means asking: what would a competent operator omit from this document if they wanted to avoid a comparison they would lose? Those omissions are where your due diligence should begin.

    The 6–12 Month IRB Problem

    The most expensive problem in U.S. first-in-human development is not device complexity, not protocol design, and not CRO selection. It is IRB latency, and almost no CRO capability deck addresses it directly.

    U.S. Institutional Review Board approval for a novel medical device at an academic medical center averages approximately 6.5 months for initial review. When protocol revision cycles are included — which is the norm, not the exception, for first-in-human device studies — full startup-to-approval timelines routinely exceed 12 months. The FDA CDRH Early Feasibility Study program documentation and MDIC’s 10-year EFS program analysis both identify study startup latency as the primary bottleneck in U.S. FIH device development — not regulatory approval, not site selection, but the ethics review cycle itself.

    At typical early-stage burn rates of $500,000–$1,000,000 per month, a 6-month IRB delay consumes $3–6 million in operating capital before a single patient is consented. For a founder with $8 million in runway targeting a 10-patient FIH study, that latency can be program-defining.

    Colombia’s INVIMA approves medical device clinical trial applications in approximately 30 days. Ethics committee approval in bioaccess®-managed studies in Colombia has been achieved in 15–18 days, with a typical portfolio range of 4–8 weeks. Argentina’s ANMAT operates under Disposición 7516/2025, which establishes a 62-working-day maximum review standard. These are not anomalies — they are the output of system design and site relationships built over 16 years of operating exclusively in first-in-human studies across 10 Latin American countries.

    The question every founder should ask every CRO before reviewing a budget proposal: “What is your documented median IRB or ethics committee approval time in your primary operating jurisdiction over the past 24 months?” If the answer is vague, that is informative. If the answer is specific and it runs past 90 days, that is more informative still.

    The First-in-Human Percentage Question

    The second question a founder should ask — and the one most CRO capability decks are built to obscure — is: what percentage of your active portfolio is Phase 1 or first-in-human?

    The three largest contract research organizations globally — ICON, Syneos, and Parexel — are concentrated in late-phase development. ICON’s 2024 Annual Report shows that the substantial majority of its revenue comes from Phase 2–4 programs; FIH studies represent a small fraction of total portfolio activity. The same is true across the large-CRO sector. This is not a criticism — it reflects where the revenue is. But it has direct operational consequences for a FIH-stage founder.

    A CRO with 5% of its active portfolio in first-in-human studies has built its project management infrastructure, its site activation processes, its deviation escalation protocols, and its regulatory file templates for the other 95%. When a FIH MedTech study enters that system, it is managed on infrastructure optimized for Phase 3 complexity: more oversight layers, more standardized QMS requirements, more administrative burden than a FIH study needs or benefits from.

    The capability deck will say “Phase 1–4 integrated capabilities.” It will not say that Phase 1 represents 4% of active studies, that the Phase 1 team shares project managers with Phase 3 programs, or that the ethics committee relationships in your target jurisdiction were last activated 18 months ago on a different therapeutic area.

    A CRO that has run first-in-human studies exclusively since inception has made the opposite set of tradeoffs. Every hire, every site relationship, every regulatory file system, and every approval timeline benchmark in that organization reflects a single operational context. That specialization compounds over time: 16 years of FIH-only operations across 10 countries produces a very different institutional knowledge base than 16 years of integrated Phase 1–4 operations in which FIH is one service line among many.

    Ask the question. Get the number.

    The Concurrent OUS FIH + U.S. EFS Structural Advantage

    The FDA’s Early Feasibility Study program was designed specifically for novel medical devices at the earliest stages of clinical development. Under 21 CFR 812.28, EFS submissions receive expedited CDRH review, with approximately 70% approved within 30 days. The MDIC’s 10-year EFS assessment documents significant improvements in study startup timelines when founders use the EFS pathway rather than traditional IDE submission.

    The structural advantage that no large CRO’s capability deck will surface clearly: a specialized FIH CRO that can execute both OUS first-in-human enrollment (in Colombia, Argentina, or elsewhere in Latin America) and concurrent U.S. EFS enrollment under a single CRO relationship changes the founder’s decision calculus in a material way.

    Under a traditional model, a founder chooses: OUS FIH first, then U.S. enrollment — running two sequential programs, often with different CROs, rebuilding the regulatory relationship each time. The concurrent model eliminates that sequencing. OUS FIH data informs the U.S. EFS design in real time. The regulatory file management, the data quality systems, and the sponsor relationship are continuous rather than episodic.

    For a large full-service CRO, EFS is one line item in a catalog of hundreds. The EFS capability will appear in the capability deck. What will not appear is how many EFS studies the team has actually executed, what their median CDRH response time has been, or whether the team managing U.S. EFS operations has any continuity with the team that would manage OUS FIH enrollment. For a CRO that has built its OUS FIH operations over 16 years and added U.S. EFS as the logical extension of that same operational model, those answers are specific and documentable.

    Ask: “How many EFS submissions has your team submitted in the past 36 months, and what is your documented median CDRH response time?” Then ask the same question about your target OUS jurisdiction. The answers should be specific.

    Three Columns: What the Deck Says, What It Omits, What to Ask

    The following framework is designed to be used during CRO evaluation, before you engage in formal proposal negotiations. Apply it to every capability deck you receive.

    What the Deck Says What It Omits What to Ask to Fill the Gap
    Integrated Phase 1–4 capabilities Percentage of active portfolio that is Phase 1 or FIH “What percentage of your active studies are first-in-human or Phase 1, and what was that percentage 24 months ago?”
    Global site footprint Ethics committee / IRB approval timelines in target jurisdiction “What is your documented median ethics committee or IRB approval time in [your target country] over the past 24 months?”
    Service line pricing / budget proposal Per-patient cost isolated for FIH stage “Please provide a line-item budget with per-patient cost isolated from site management and overhead fees.”
    FDA acceptance language EFS submission volume and documented CDRH response times “How many EFS submissions has your team managed in the past 36 months, and what is your median CDRH response time?”
    Therapeutic area expertise Medical device FIH-specific experience vs. drug/biologic Phase 1 “What percentage of your Phase 1 portfolio is medical device studies under IDE or EFS, vs. drug or biologic IND?”

    The three-column exercise does not require adversarial questioning. A CRO with genuine FIH specialization will answer every question above with specific, documentable data. The absence of specific answers is itself the answer.

    Reading a CRO capability deck like a regulator means treating every foregrounded strength as a signal to ask what is structurally absent on the other side of that strength. The 40 slides are not the decision. The five questions above are the decision.

    Next Steps

    If you are evaluating CRO options for a first-in-human study and want a direct conversation about how bioaccess®® structures FIH programs in Latin America — including ethics committee timelines, per-patient cost benchmarks, and concurrent U.S. EFS execution — schedule a consultation at bioaccessla.com/book-a-meeting.

    To model the cost difference between U.S./EU and LATAM FIH execution for your specific protocol, use the bioaccess® clinical trial cost calculator.

    For the foundational framework this post extends — the five questions to ask before signing a CRO MSA — see Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA.

    Sources


  • Ophthalmic First-In-Human Studies In Latin America: Why Smaller Markets Often Move Fastest

    Ophthalmic First-in-Human Studies in Latin America: Why Smaller Markets Often Move Fastest

    For ophthalmic medical device founders running their first-in-human (FIH) program — intravitreal injectors, glaucoma microshunts, retinal delivery platforms, intraocular lens innovations — the conventional wisdom says you go to a country with the largest patient pool and the most prestigious eye institutes. In Latin America, that usually points sponsors toward Mexico or Brazil first.

    That instinct is right for pivotal studies. For an FIH or early-feasibility study with 5 to 15 patients, however, our operational experience consistently shows a different pattern: smaller markets like El Salvador, Panama, and the Dominican Republic often deliver a faster path to first patient in. Here is why, and how to think about country selection for an ophthalmic FIH program.

    The FIH Math Is Different from the Pivotal Math

    Pivotal studies select for patient pool depth, statistical power, and reimbursement signal. FIH studies select for something else entirely: speed to first dose, regulatory predictability, and quality of investigator engagement on a small handful of patients.

    For a 10-patient ophthalmic FIH study, the binding constraint is rarely “are there enough eligible patients in the country” — almost any LATAM country has thousands of glaucoma, AMD, or refractive candidates. The binding constraints are:

    • Time from sponsor decision to first ethics committee submission
    • Time from EC approval to first patient screened
    • Investigator focus and availability across the dosing window
    • Regulatory predictability for a novel device class

    On all four, smaller markets often outperform the regional giants for FIH-stage work.

    Why Smaller Markets Move Faster on Ophthalmic FIH

    Three structural factors explain it.

    1. Lighter EC and regulatory queues. An ethics committee at a leading eye hospital in El Salvador or Panama might review three to six device protocols per quarter. The equivalent committee at a top São Paulo or Mexico City institute might be working through 30 to 60. Both are competent and rigorous; one simply has more capacity for a fast-track FIH protocol.

    2. Concentrated investigator attention. In smaller markets, a leading ophthalmologist running an FIH study is not splitting attention across 12 simultaneous trials. The principal investigator has direct line of sight on every screening visit, every dosing event, every follow-up — the kind of operational intimacy that materially reduces protocol deviations and data queries on a small-N study.

    3. Tighter sponsor-to-site communication. Smaller hospital systems mean fewer layers between sponsor, CRO, principal investigator, and ethics coordinator. A protocol clarification that takes a week to circulate at a large academic center can be resolved in a 30-minute call in a smaller setting.

    What This Looks Like in Practice for an Ophthalmic FIH

    For an intravitreal device, glaucoma microshunt, or refractive implant FIH program, a well-structured small-market approach typically looks like this:

    • Single-country FIH (5–10 patients). Concentrate enrollment at one or two specialized eye centers in a smaller market. Optimize for speed and data quality, not geographic diversity.
    • Validated translation and regulatory packets ready before EC submission. Smaller markets are fast on substance but unforgiving on document inconsistency.
    • Compressed feasibility-to-FPI window. A 6 to 8 week target from sponsor go-decision to first patient enrolled is achievable when site, EC, and country regulator are aligned from day one.
    • Clean handoff to a multi-country pivotal. Once FIH safety data is in hand, the pivotal can move to Mexico, Brazil, Argentina, or a multi-country footprint with the FIH evidence already supporting site selection conversations.

    When the Conventional Path Still Wins

    Smaller markets are not the right choice for every ophthalmic FIH. Three situations argue for going to Mexico or Brazil first:

    • Genetic ophthalmic indications where a specific sub-population is concentrated in one large country.
    • Complex imaging endpoints requiring a specific OCT, ultra-widefield imaging, or AI-assisted analysis platform that is only operational at a handful of large academic centers in the region.
    • Founder-led key opinion leader strategy where the FIH publication-to-investor narrative depends on a specific principal investigator’s involvement.

    For most early-stage ophthalmic device sponsors, however, the speed advantage of smaller markets at the FIH stage translates directly into reduced cash burn during the most capital-fragile window of the company’s life. In an industry where 90% of MedTech startups fail because they run out of capital before generating clinical evidence, that compression matters.

    Frequently Asked Questions

    How quickly can a well-designed ophthalmic FIH actually start in a smaller LATAM market?
    With prepared documents, an experienced site, and a clear regulatory pathway, 6 to 10 weeks from contract signature to first patient screened is realistic. The variability comes from how prepared the sponsor’s regulatory packet is, not from the country’s regulatory speed.

    Will FDA accept FIH data from El Salvador, Panama, or the Dominican Republic?
    Yes, under 21 CFR 812.28, provided the study is conducted in compliance with ICH-GCP. The FDA does not maintain a country whitelist; it evaluates each study on the quality of its execution, documentation, and ethics oversight.

    Should we run the FIH in a smaller market and then move the pivotal to Brazil or Mexico?
    This is a common and effective sequencing strategy for ophthalmic device programs. Smaller markets optimize for speed at the FIH stage. Larger markets optimize for enrollment depth, infrastructure, and regulatory signal at the pivotal stage. Designing the FIH protocol with the eventual pivotal in mind — same imaging modalities, same primary endpoint definitions, same data capture standards — makes the transition seamless.

    bioaccess® is the world’s only contract research organization built exclusively for first-in-human medical device trials, operating across 10 Latin American countries. Explore the FIH playbook at bioaccessla.com or estimate a study at bioaccessla.com/clinical-trial-calculator.

  • Anvisa’s 2026–2027 International Convergence Agenda: What Medtech Sponsors Need To Plan For

    ANVISA’s 2026–2027 International Convergence Agenda: What MedTech Sponsors Need to Plan For

    Brazil’s medical device regulator, ANVISA, is in the middle of the most aggressive period of international regulatory convergence in its history. Between the mid-2024 Brazilian Clinical Research Law (Lei 14.874) becoming fully operative on January 1, 2025, and the agency’s published 2026–2027 priorities, the rules around clinical trial submissions, post-market surveillance, software as a medical device (SaMD), and unique device identification (UDI) are all changing simultaneously.

    For MedTech sponsors planning to use Brazilian clinical data in US, EU, or Brazilian regulatory submissions, the next 18 months are a strategic window. Here is what is changing, why it matters, and how to plan for it.

    What Is Actually Changing

    Three convergence streams are running in parallel.

    1. Stronger international cooperation on device review. ANVISA has expanded its participation in international regulatory work-sharing arrangements, including the Medical Device Single Audit Program (MDSAP) and increased reliance agreements with FDA, EMA, and Health Canada-equivalent regulators. The practical effect: a device that has cleared review in a recognized reference jurisdiction can move through Brazilian registration substantially faster than under the old country-by-country framework.

    2. New SIUD database and UDI implementation. ANVISA’s Sistema de Informação de Identificação Única de Dispositivos Médicos (SIUD) is being phased in across 2026, requiring UDI assignment, labeling, and database submission for medical devices entering the Brazilian market. The phase-in follows risk class — Class IV (highest risk) and IVDs first, then descending through Class III, II, and I over the multi-year timeline.

    3. Software-as-a-medical-device pathway clarification. ANVISA has published updated normative instructions for SaMD classification, including AI-enabled clinical decision support, aligning more closely with FDA and IMDRF frameworks. For digital health and AI MedTech sponsors, the Brazilian pathway is now substantially more predictable than it was 24 months ago.

    All three streams are happening on top of the already-operative parallel review framework under Lei 14.874, which lets sponsors submit to ANVISA and the institutional ethics review system simultaneously rather than sequentially.

    Why the Window Matters Now

    For sponsors planning a Brazilian arm of a clinical trial — or a market access registration — three strategic implications flow from the current convergence wave.

    Documentation prepared for FDA or EU MDR is increasingly leverageable in Brazil. The technical file structure, risk classification reasoning, and clinical evidence summary you build for an FDA 510(k), De Novo, or EU MDR conformity assessment now translates more directly into ANVISA’s expectations than at any prior moment. The historical penalty of duplicating documentation across regions is materially smaller in 2026 than it was in 2022.

    The window for “first to file under the new framework” is open. Regulatory teams that align Brazilian submissions with the new convergence framework now will move ahead of teams that wait for further clarification. Once a sponsor has navigated one device through the new SIUD or updated SaMD pathway, every subsequent submission moves faster.

    Post-market obligations are being modernized. The new SIUD database is not just a labeling exercise — it forms the backbone of a more sophisticated post-market surveillance regime. Sponsors who structure their data capture and adverse event tracking systems to align with the new SIUD inputs from day one save significant retrofit cost later.

    Practical Planning for the Next 12 to 18 Months

    Three actions are appropriate for any sponsor with Brazilian exposure or plans:

    • Audit your UDI strategy now. If your device class is in the early SIUD phase-in, allocate budget and labeling capacity in 2026. If your device is in a later phase, use the next 12 months to harmonize UDI assignment with the FDA UDI database and the EU EUDAMED framework so all three jurisdictions are covered with a single system.
    • Restructure your technical file with convergence in mind. The 2026 reality is that one well-organized technical file should serve FDA, EU MDR, and ANVISA submissions with mostly mechanical translation steps and only modest jurisdiction-specific addenda. If your team is still maintaining three parallel files, the next 12 months are the right window to consolidate.
    • Engage early on SaMD classification. If your device incorporates software, AI, or clinical decision support, ANVISA’s updated framework means that a pre-submission classification conversation now yields meaningfully more predictable answers than two years ago. Take advantage of that predictability before launching the trial.

    Frequently Asked Questions

    Does the new ANVISA convergence framework affect clinical trial submission timelines?
    Yes — primarily through Lei 14.874’s parallel review mechanism, which lets ANVISA and ethics committees review submissions simultaneously instead of sequentially. The practical effect is a several-week to several-month reduction in start-up timelines compared with the pre-2025 framework, depending on device complexity.

    If my device is FDA-cleared, will ANVISA accept the FDA submission as-is?
    Not as-is. ANVISA’s reliance and convergence framework reduces duplication but does not eliminate the need for a Brazil-specific submission. What it does change is that your FDA-aligned technical file, risk classification logic, and clinical evidence package now translate more directly into ANVISA expectations, with smaller jurisdiction-specific gaps to fill.

    How does the SIUD database affect sponsors who do not yet sell in Brazil?
    If you have no Brazilian commercial presence and no plans for one, SIUD does not directly apply. If you are running a clinical trial in Brazil intending to commercialize there later — or to use Brazilian data in support of a future commercial registration — building UDI alignment into your trial-stage device labeling now is materially cheaper than retrofitting it later.

    bioaccess® supports first-in-human and early-feasibility medical device trials across 10 Latin American countries, including Brazil under ANVISA’s modernized framework. Learn more at bioaccessla.com or book a strategy conversation at bioaccessla.com/book-a-meeting.

  • Five Questions Every Medtech Founder Must Ask A CRO Before Signing The MSA






    Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA


    Five Questions Every MedTech Founder Must Ask a CRO Before Signing the MSA

    Published by bioaccess®® | May 2026

    The Most Expensive Vendor Decision You Will Make Before Your Series B

    The master services agreement you sign with a CRO at the first-in-human stage is not just a vendor contract. It is a commitment to a timeline, a data architecture, a regulatory strategy, and — in ways most founders do not fully price until they are inside the engagement — a bet on whether that organization has ever actually done this before.

    Most MedTech founders spend more time negotiating SaaS subscription pricing than interrogating the operational fitness of the CRO they are about to trust with their first human study. CROs are practiced at presenting capability decks that are both technically accurate and structurally misleading: yes, they have run first-in-human studies. The questions are how many, how recently, where, and with what kind of dedicated team.

    Getting this wrong is costly in ways that do not appear on the MSA. A generalist CRO that applies Phase 3 operational logic to a 10-patient FIH study produces delays and data packages that do not travel well to FDA. The five questions below are designed for use in an actual vendor conversation, written so that an organization built specifically for first-in-human work answers all five without hesitation and a generalist CRO with Phase 3 heritage struggles on at least three. The contrast is the diagnostic.

    Question 1: “What percentage of your active studies are first-in-human?”

    This question cuts through every capability deck. Most large CROs list “Phase 1-4” as an integrated capability — and that is technically accurate. ICON, Syneos Health, and Parexel all offer first-in-human services. What their materials do not disclose is the proportion of revenue, headcount, and operational attention that FIH commands relative to their Phase 2-4 and post-market portfolio. According to the ICON plc 2024 Annual Report, the company’s growth narrative is anchored in Phase 2-4 and functional service offerings. Syneos Health’s service model is similarly configured around integrated biopharmaceutical solutions at scale — not the 10-patient device feasibility study a seed-stage founder needs to execute.

    The operational implication: when FIH is a small fraction of a CRO’s active portfolio, the project managers on your study are people who primarily run Phase 3 logistics. They understand protocol compliance and site management at the multi-site scale. What they may not have is the judgment that comes from running dozens of first human exposures — the real-time risk calculus of dose escalation, the site selection nuances that matter when you have ten patients rather than three hundred, and the FDA communication posture that FIH-specific experience produces.

    The follow-up question matters equally: “Who on your team has personally run more than ten first-in-human studies from device selection through first patient in?” An organization that cannot surface a dedicated FIH unit with named individuals and verifiable track records has not built FIH as an operational discipline.

    Red flag: Any CRO that cannot give you a clean percentage of active studies that are first-in-human has not built FIH as an operational core. It is a line item in a service menu. A CRO for which FIH is the only practice answers this question with a number above 90 percent — because there is nothing else on the portfolio.

    Question 2: “What is your documented median time from IND/IDE submission to site initiation in your primary jurisdiction?”

    Timeline is not a soft preference. It is a capital efficiency variable. Every month between IND/IDE equivalent submission and first patient in is a month of runway consumed and a month of competitive exposure while your device sits in regulatory review.

    The documented benchmark for ethics committee approval in Latin American FIH programs — for organizations with established site relationships and a mature submission infrastructure — is 4 to 8 weeks. In Colombia, where the regulatory framework has been shaped by over a decade of FIH execution, approval instances as fast as 15 to 18 days have been recorded. This is the result of site-level relationships, submission formatting that ethics committees recognize, and a regulatory team with institutional familiarity with the FIH protocol type.

    The U.S. comparison is not subtle. The average IRB/EC cycle in the United States for a novel device IDE study runs 6 to 12 months from submission to site initiation when you account for FDA review, IRB submission, site contracting, and institutional compliance review. In the EU, a 6-month horizon from IDE equivalent to first patient in remains the conservative planning assumption most regulatory counsel will give you.

    Illustrative Ethics Approval Timeline Comparison
    Jurisdiction Documented Range Basis
    LATAM (Colombia, established sites) 4-8 weeks (fastest: 15-18 days) bioaccess® operational track record, 2010-present
    United States (IDE pathway) 6-12 months (submission to site initiation) FDA CDRH IDE review statistics
    EU (CTR pathway) 3-9 months (submission to site initiation) EMA Clinical Trials Regulation implementation data

    When you ask this question, you are asking for documented median performance, not a best case. An organization that cannot answer with data has not been measuring what matters.

    Question 3: “Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?”

    The most persistent misconception among U.S. device founders about outside the United States clinical data is that FDA will not accept it. This misconception is expensive, because it leads founders to dismiss LATAM and other OUS execution pathways as regulatory dead ends when the regulatory framework explicitly accommodates foreign clinical data.

    21 CFR 312.120 permits FDA acceptance of foreign clinical data when the trial was conducted in accordance with Good Clinical Practice and under a protocol FDA would consider adequate and well-controlled. 21 CFR 812.28 extends parallel provisions to device studies, explicitly addressing acceptance of data from foreign investigations in support of IDE and PMA submissions.

    A first-in-human study conducted in Colombia, Brazil, or Peru under a GCP-compliant protocol, with a data architecture designed to meet FDA standards, can generate the foundational data package that supports a U.S. IDE submission. The LATAM study is not a workaround. It is a legitimate regulatory pathway.

    Executing it correctly requires a CRO that has actually done it. “We could produce FDA-compatible data” is not the same as “we have produced FDA-accepted data from an OUS trial in the past three years.” Ask for the latter. Ask for the regulatory outcomes. Ask whether the data traveled to FDA and what the response was.

    A CRO that has never navigated 21 CFR 312.120 or 812.28 in practice — regardless of what their regulatory affairs team says in a capabilities presentation — is asking you to be their learning case at the stage where you cannot afford that tuition.

    Question 4: “What is your per-patient cost range for a 10-to-15 patient FIH study in your primary jurisdiction?”

    Per-patient cost for a FIH study is the single most compressed way to understand the financial architecture of a CRO engagement before you are inside one. Cost transparency at the proposal stage is not a courtesy — it is a due diligence requirement.

    The documented range for per-patient costs in Latin American clinical trial sites runs from approximately $15,000 to $35,000 per patient for a first-in-human medical device study. The equivalent range in the United States and European Union runs from $40,000 to $75,000 per patient for comparable FIH work. That differential — roughly 59 percent lower cost per patient in LATAM — reflects the structural economics of clinical site operations in markets where investigator compensation, institutional overhead, and support cost structures differ materially from U.S. and EU norms.

    On a 10-patient FIH study, the arithmetic is direct: U.S. execution at $40,000-$75,000 per patient produces a $400,000-$750,000 direct study cost. LATAM execution at $15,000-$35,000 per patient produces a $150,000-$350,000 direct study cost. The difference — $250,000 to $400,000 — is material capital at the seed or pre-Series A stage. It extends runway. It funds the follow-on safety cohort. It covers FDA pre-submission preparation. It is the difference between a founder who enters their Series A with FIH data and remaining runway, and one who spent it all to generate the same data in a U.S. site.

    A CRO that deflects to “it depends on the protocol” without offering a range for a standard FIH configuration has either not run enough FIH studies to have a stable cost model, or does not want you comparing numbers before you have signed.

    Question 5: “Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?”

    The FDA’s Early Feasibility Study program is one of the most underutilized regulatory tools available to U.S. MedTech founders. According to the FDA Early Feasibility Study Program, the EFS pathway is designed for early-stage devices where clinical data is needed to inform device design — precisely the stage at which a FIH study occurs. The MDIC 10-Year EFS Journey analysis documented that approximately 70 percent of EFS submissions receive FDA response within 30 days — a timeline that makes concurrent OUS and U.S. enrollment operationally feasible within the same funding window.

    The strategic logic of concurrent execution is about data architecture, not just speed. A LATAM FIH study generating safety and early efficacy signals in parallel with a U.S. EFS enrollment produces a richer, more FDA-defensible data package than either study would generate independently. The LATAM cohort contributes patient volume and diverse population data; the U.S. cohort generates data with direct site-level FDA familiarity. Together, they build an IDE submission or PMA dataset from a position of evidence rather than assumption.

    Executing this dual-track strategy requires a CRO that can manage both pathways under a coherent operational structure — not two separate vendor relationships requiring a founder as the integration layer. The question diagnoses whether a CRO has built the capacity to hold both regulatory tracks in a single team, or is offering LATAM execution on one hand and a referral to a U.S. partner on the other.

    The U.S. EFS pathway and a concurrent LATAM FIH study are not competing strategies. They are the same strategy, executed in parallel, by an organization that understands both regulatory environments as a single integrated operation.

    How to Use This Checklist

    These five questions are not adversarial. They are clarifying. A CRO that has built its operations around first-in-human work will not find them uncomfortable — they will find them efficient, because the answers surface quickly from an organization that lives in this space every day.

    Use the questions in the initial capabilities conversation, before you have a proposal on the table and a timeline pressure that makes switching feel costly. The moment to evaluate operational fit is before you have signed anything, not after you are inside a study running six months behind the timeline the capabilities deck implied.

    • What percentage of your active studies are first-in-human?
    • What is your documented median time from IND/IDE equivalent submission to site initiation?
    • Have you produced a data package accepted by FDA from a non-U.S. trial in the past 36 months?
    • What is your per-patient cost range for a 10-to-15 patient FIH study?
    • Can you execute an EFS submission and manage a concurrent OUS FIH study under a single operational team?

    If the answers satisfy all five questions, you are talking to a CRO that may be able to run your first human study competently. If they do not, you have learned something before the signature, not after.

    Ready to Run the Evaluation?

    bioaccess® works with MedTech founders at every stage of FIH preparation — from regulatory strategy through first patient in. If you want to talk through your specific program against these five criteria:

    Sources