What to expect when you partner with bioaccess® for a first-in-human trial
The goal of this guide is straightforward: walk you, a MedTech, Biopharma, or Radiopharma startup founder or clinical leader, through every stage of a first-in-human (FIH) trial engagement with bioaccess®, from the first conversation to the moment your first patient is enrolled.
bioaccess® has operated as a specialist contract research organization (CRO) focused exclusively on FIH and early-feasibility trials since its co-founding in 2010. Headquartered at 1200 Brickell Ave, Miami, FL, the team has served 50+ client companies, operates across 19 Latin American and Caribbean countries, and maintains a network of 50+ pre-qualified clinical trial sites. The model is designed for one job: generate submission-ready human clinical evidence faster than is typically achievable in the U.S., while keeping that evidence anchored to U.S. Food and Drug Administration (FDA) strategy.
Latin American ethics committees routinely review FIH protocols on a timeline set by each committee’s meeting schedule, compared with 6 to 12 months in the U.S. (bioaccessla.com/first-in-human-cro). On the regulatory side, in-country approvals commonly land in 1 to 3 months versus 3 to 12 months in the U.S. First patient enrolled runs 4 to 8 months in LATAM versus 12 to 18 months in comparable U.S. programs (bioaccessla.com/costs-and-timelines). These are published experience-based benchmarks, not guarantees for any single program.
The engagement runs through bioaccess®’s FIH-12™ program: a 9-component clinical development methodology with a 12-month timeline guarantee. FIH-12™ covers U.S. regulatory strategy and pre-submission planning; parallel ethics and regulatory filings; pre-qualified site activation; accelerated patient enrollment; real-time remote monitoring; streamlined data management; and FDA bridge data package preparation.
You’ll own certain decisions throughout. bioaccess® owns execution. The sections below map exactly who does what at every handoff.
Step 1: Gather your documents before the intake call
The pre-engagement goal is to convert whatever your startup currently has into a submission-ready dossier. The sooner you assemble these materials, the sooner bioaccess® can deliver a Pre-Sub Gap Analysis (within 48 hours of intake) and an FIH Budget and Timeline Blueprint.
Sponsor readiness intake checklist
Technical and protocol inputs:
- Device or therapy description (name, mechanism of action, intended use, indication)
- Protocol draft or study design outline (even a concept document is useful)
- Investigator Brochure (IB) or equivalent technical file
- Risk/benefit narrative or safety rationale summary
- Any prior clinical use data, bench testing, or animal study summaries
Nonclinical inputs:
- Preclinical package summary (in vitro, in vivo, biocompatibility as applicable)
- Supporting rationale for first-in-human dosing or device operating parameters
- Any regulatory correspondence already received (e.g., FDA feedback, prior Pre-Sub responses)
Regulatory and evidence strategy inputs:
- Your intended U.S. pathway: Investigational Device Exemption (IDE), Pre-Submission (Pre-Sub), Investigational New Drug (IND), 510(k), De Novo, Premarket Approval (PMA), or Humanitarian Device Exemption (HDE). If you haven’t committed, share your current thinking.
- Whether you’re targeting an Early Feasibility Study (EFS) under the FDA’s EFS Program or a standard FIH design
Operational inputs:
- Target countries or regions (Colombia/INVIMA, Panama/MINSA, El Salvador, other LATAM markets)
- Intended site types (hospital, ambulatory, academic center)
- Investor or board milestone pressure: dates that create hard constraints
What happens at the handoff
You deliver the materials above. bioaccess® produces: a Pre-Sub Gap Analysis (48-hour turnaround), an FIH Budget and Timeline Blueprint, and a country and pathway recommendation.
Checkpoint: If you can’t provide a preclinical safety summary or a defined U.S. pathway intent, bioaccess® can still initiate a discovery plan and gap analysis. Submission timelines will extend, though. Resolve both items before you commit to an ethics submission date.
Step 2: Lock in the U.S.-anchored regulatory strategy
Running a trial in Latin America doesn’t mean building data that only matters in Latin America. The evidence generated through bioaccess® is structured to support subsequent FDA-related pathways, whether that’s an IDE application, a Pre-Sub package, or a broader regulatory dossier.
FDA acceptance of foreign clinical data is governed by 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs and biologics). bioaccess® builds what it calls an “812.28-Ready Data Room” for device programs under ISO 14155 Good Clinical Practice (GCP), designed so the data structure and quality are consistent with FDA eligibility requirements. Whether FDA accepts any specific submission is FDA’s decision on a case-by-case basis. The design intent, however, is set at the start.
Work through these four steps inside this stage
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Confirm your target U.S. pathway. You finalize the intended route (IDE, PMA, De Novo, 510(k), IND, or equivalent). bioaccess® needs this to architect the protocol and evidence package correctly.
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Complete the gap assessment. bioaccess® reviews your intake documents against the evidence requirements for your stated pathway and identifies missing elements: preclinical gaps, protocol deficiencies, IB gaps, or missing device description components.
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Align protocol architecture and evidence requirements. bioaccess® authors or co-authors the protocol (ISO 14155-compliant for devices; ICH E6/GCP-aligned for drugs), aligns the IB, and sets the standard operating procedures (SOPs) that will govern trial conduct.
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Prepare sponsor-side contributions for local submissions. You’ll need to review and sign off on the technical content of the dossier. bioaccess® handles documentation architecture and submission execution; you own accuracy of the underlying technical information.
Who does what: You provide truthful technical content, approve final filings, and make yourself available for clarification questions with a defined turnaround time. bioaccess® handles strategy alignment, document structuring, and submission mechanics.
Checkpoint: Before moving to ethics submission, confirm the data room structure is in place and that both sides agree on the evidence package approach for the stated 21 CFR 812.28 or 21 CFR 312.120 framing.
Step 3: Submit to the ethics committee and manage the review
In each target country, the FIH protocol and all subject-facing materials must pass review by a local Institutional Review Board (IRB) or ethics committee before enrollment can begin. This step runs in parallel with in-country regulatory submission wherever the jurisdiction allows it, which is one of the structural advantages that FIH-12™ exploits to compress timelines.
The ethics submission sequence
- bioaccess® builds the local ethics dossier: translated and localized protocol, informed consent form (ICF), subject-facing documents, and supporting materials.
- bioaccess® submits the complete dossier to the ethics committee.
- Ethics committee query responses are managed by bioaccess®, with a defined sponsor response window for any questions requiring your technical input.
- Approval letter received.
- Proceed to national regulatory submission (where required sequentially) and site activation.
As published on bioaccessla.com/first-in-human-cro, Latin American ethics committees commonly review FIH protocols on a timeline set by each committee’s meeting schedule. For reference, ethics timing in Colombia (INVIMA pathway) and Panama (MINSA/CNBI) also follows each committee’s meeting schedule. Under Executive Decree 21 of 2026, MINSA also registers the study in RESEGIS (receipt within 3 business days, Art. 86) and, for high-risk research, runs a technical review in parallel with the ethics review that must be resolved before the committee’s final decision (Arts. 88–91); the DNFD pharmacy review applies where Art. 95 says so. El Salvador carries a published 30-day startup benchmark.
Where delays actually come from
Three issues slow ethics reviews more than anything else: incomplete or inconsistently localized ICF content, protocol amendments submitted without version control, and missing principal investigator signatures or institutional authorizations. bioaccess® tracks all committee queries, manages document versioning, and flags any item that needs sponsor input on the same day it arrives.
Checkpoint: Ethics approval letter in hand is the gate to site activation and first-patient preparation. Don’t start activation logistics before this document is received.
Step 4: Select and activate your clinical site
Choosing the right investigator and center matters as much as the regulatory route. For FIH and early-feasibility work, the site needs to have safety infrastructure, qualified investigators with device- or therapy-relevant experience, and the operational capacity to onboard quickly.
bioaccess® maintains 50+ pre-qualified sites across 19 LATAM and Caribbean countries. Site activation is built into FIH-12™ and runs in parallel with late-stage ethics review wherever possible.
Site activation sequence
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Run feasibility checks. bioaccess® screens candidate sites against your protocol’s inclusion/exclusion criteria, required equipment, and investigator qualifications. You review the shortlist and confirm.
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Build the activation plan. Contracting, budget agreements, and required institutional sign-offs are coordinated by bioaccess®. You provide device handling requirements, shipping and storage specifications, and any technical documentation the site team needs.
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Complete contracting and approvals workflow. Site contracts and Clinical Trial Agreements are executed. You review and approve financial terms.
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Conduct start-up training. bioaccess® trains the site team on the protocol, data collection systems, device handling (for device studies), and safety reporting procedures.
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Hold the investigator and study team kickoff. The principal investigator, sub-investigators, coordinators, and bioaccess® monitors align on the enrollment start plan.
Who does what: You supply device or investigational medicinal product (IMP) handling requirements and technical documentation. bioaccess® coordinates site readiness, manages activation logistics, and runs the training program.
Checkpoint: Site activation is complete and site team is trained before the first subject is screened. Both items must be confirmed in writing.
If your first-choice site stalls: bioaccess® maintains backup sites in the same country and in alternate countries within the network. Parallel feasibility work across two sites during the ethics phase is the most reliable way to avoid a single-site bottleneck.
Step 5: Screen, enroll, and manage the study through first patient
First patient enrolled (FPE) is the operational milestone that converts planning into evidence. From this point, the study runs under bioaccess®’s ongoing monitoring and data management infrastructure.
Enrollment sequence
- Confirm screening readiness. Site team confirms patient identification processes are active. bioaccess® verifies data capture systems are live.
- Execute the patient recruitment and retention plan. bioaccess® supports accelerated enrollment through site-level recruitment planning; you confirm any sponsor-specific eligibility constraints.
- Complete first implantation or dose administration. The principal investigator performs the procedure. bioaccess® monitors in real time.
- Activate ongoing monitoring. Real-time remote monitoring begins at first patient. Data flow, safety reporting, and query management run through bioaccess®’s systems.
For context, one published device FIH study in Colombia secured regulatory approval in 5 weeks, completed first-in-human implantations, validated a safety profile in human subjects, and generated clinical data for FDA submission planning.
Who does what post-activation: You remain available for safety and medical questions, approve any protocol amendments, and review interim data packages. bioaccess® runs monitoring, data management, safety data flow, and study execution oversight. Monthly board-ready progress reports are standard deliverables.
Checkpoint: First patient enrolled, first data point collected, and milestone reporting cadence established. These three items confirm the study is live.
Sponsor responsibilities and communication cadence
The faster you respond, the faster the timeline moves. Delays in sponsor-side approvals are the most common source of onboarding slippage across all CRO engagements.
What you own throughout the engagement:
- Accuracy of all technical content submitted to any authority
- Timely review and sign-off on localized materials (ICF, protocol, site contracts)
- Response to ethics and regulatory queries requiring technical input (defined turnaround window agreed at kickoff)
- Availability for safety decisions and protocol amendment approvals during conduct
What bioaccess® owns:
- Regulatory anchoring strategy and Pre-Sub/IND/IDE planning inputs
- Ethics and in-country regulatory submission management
- Site activation coordination across the LATAM network
- Enrollment execution support, real-time remote monitoring, and data management
- Assembly and delivery of the submission-supporting evidence package (812.28-Ready Data Room for devices)
Communication structure
Set this up before the first submission:
- Weekly milestone review calls during the pre-submission and ethics phases
- 24- to 48-hour sponsor response SLA for ethics or regulatory queries requiring your input
- A named regulatory or clinical point of contact on your side who can answer technical questions quickly
- An escalation path (to your CEO or CMO) if sign-offs lag and timeline risk accumulates
Checkpoint: Before any document is submitted to an ethics committee or regulatory authority, confirm named document owners, distribution lists, and agreed response turnaround times are documented and shared.
For the full phase-by-phase picture, from protocol synopsis to first patient, with durations and each country’s review order, see our guide to clinical trial site activation timelines in Latin America.
Sample milestone timeline and readiness checklists
Text-based onboarding milestone map
Week 1–2: Sponsor intake documents received
bioaccess® delivers Pre-Sub Gap Analysis (48-hour turnaround)
FIH Budget & Timeline Blueprint issued
Week 2–4: U.S. regulatory strategy confirmed
Protocol architecture and evidence package aligned
Ethics dossier built and localized
Week 4–8: Ethics submission (LATAM ethics committees commonly review on a timeline set by each committee's meeting schedule)
Parallel in-country regulatory submission where jurisdiction allows
Site feasibility checks and backup site work running in parallel
Week 8–12: Ethics approval received (gate)
Site activation and investigator training
Regulatory approval received (LATAM range: 1–3 months)
Week 10–16+: Site activation confirmed (gate)
First patient screened
First patient enrolled (LATAM experience-based range: 4–8 months from program start;
actual timing depends on country, dossier completeness, and enrollment criteria)
Country examples: ethics review in Colombia (INVIMA) and Panama (MINSA/CNBI) depends on each committee’s meeting schedule, with MINSA’s RESEGIS registration (receipt within 3 business days) and, for high-risk research, a parallel MINSA review that must be resolved before the committee’s final decision (Executive Decree 21 of 2026, Arts. 86 and 88–91; DNFD pharmacy review where Art. 95 applies); El Salvador has a 30-day startup benchmark. Chile charges no regulator fee, while Costa Rica adds a 3% CONIS levy, the only such levy in Latin America. For budgets, see the bioaccess® sample budget at bioaccessla.com/sample-budget-fih-trial-latin-america (illustrative, not a quote).
Sponsor readiness checklist (self-validate before your first call)
- Protocol draft or study design concept document exists
- Device description or therapy description written and current
- Investigator Brochure or technical file available (even in draft form)
- Preclinical safety summary available or in preparation
- Target U.S. regulatory pathway identified (IDE, Pre-Sub, IND, 510(k), De Novo, PMA, or HDE)
- Target countries or preferred LATAM jurisdictions identified
- Localized informed consent content status known (not yet started, in draft, or complete)
- Named regulatory or clinical point of contact confirmed internally
- Decision-makers available for document sign-offs within 48 hours
Onboarding milestone gates
- Gate 1: Dossier completeness confirmed by bioaccess® before ethics submission
- Gate 2: Ethics dossier submission complete and confirmation received from committee
- Gate 3: Ethics approval letter received
- Gate 4: Site activation complete and site team trained
- Gate 5: First patient enrolled and data collection active
When things don’t go as planned
Ethics questions arrive later than expected. bioaccess® flags the incoming query on the same day and categorizes it as sponsor-response-required or bioaccess®-answerable. If it’s yours, respond within the agreed SLA. A query that sits unanswered for a week is the fastest way to push a milestone gate by two.
Site activation stalls. If the primary site hits a contract or institutional delay, bioaccess® moves to the pre-identified backup site in the same country. Parallel feasibility work started during the ethics phase means the backup is already partially qualified, not starting from zero.
Enrollment lags because screening criteria are too tight. Review inclusion/exclusion criteria with the principal investigator and bioaccess® medical team. Overly restrictive criteria are typically identifiable during the protocol alignment step (Step 2), but if they surface at enrollment, a protocol amendment may be faster than waiting for a site with a different patient population.
The path from initial consultation to first patient is predictable when every document handoff, milestone gate, and responsibility boundary is clear before work starts. bioaccess® has run this process for 50+ client companies across 19 markets. The infrastructure, pre-qualified site network, and regulatory anchoring methodology are already built.
Book a strategy call to map your FIH onboarding timeline and get your Pre-Sub Gap Analysis within 48 hours.
