- What Altasciences Does
- What bioaccess® Does
- Altasciences vs bioaccess®: A Direct Comparison
- Why the Distinction Matters for Device Sponsors
- The Geography Question
- The Cost Structure
- Radiopharmaceuticals: A Specific Differentiator
- Which CRO Fits Which Sponsor
- Frequently Asked Questions
- Conclusion
Before any side-by-side comparison of Altasciences and bioaccess® makes sense, one detail needs to be on the table: Altasciences operates a site branded "Altasciences LA" — and that LA stands for Los Angeles, not Latin America. These two organizations serve different sponsor profiles, operate in different geographies, and are built around fundamentally different regulatory strategies. What follows breaks down where each CRO fits, what each actually delivers for device sponsors, and how they compare on the dimensions that matter most to a startup working within a $1 million to $5 million FIH budget with a funding milestone approaching.
What Altasciences Does
Altasciences is a Canadian-founded CRO with North American operations, including a clinical pharmacology unit in Los Angeles. Its core business is early-phase drug and molecule work: Phase I pharmacokinetics, bioavailability, bioequivalence, and first-in-human dosing studies for pharmaceutical and biotech sponsors.
The organization has built a solid reputation in small-molecule and biologic Phase I work. Its clinical pharmacology units are designed for controlled, single-site drug administration studies where the primary endpoint is a PK or PD measurement.
For medical device sponsors, that creates a structural mismatch. Device FIH trials require a different operational model entirely: multi-site enrollment, implant or procedure-based endpoints, Ethics Committee (EC) review under ISO 14155, and a data package structured for FDA 21 CFR 812.28 or IDE submission. Altasciences' infrastructure is built around drug metabolism — not device implantation or procedure-based evidence generation. The company has no documented LatAm FIH capability, no 30-to-90-day regulatory approval positioning, and no published device-specific trial network in Latin America.
That is not a criticism. It is simply a description of what Altasciences is built to do. Device FIH is not it.
What bioaccess® Does
bioaccess® is a Miami-headquartered CRO built specifically for medical device, biopharma, and radiopharmaceutical sponsors running first-in-human and early feasibility studies. Its primary service, the FIH-12™ program, is a nine-workstream, 12-month engagement covering FDA Pre-Sub and IDE/IND pathway alignment, protocol development, site activation, patient enrollment, data management, and delivery of a submission-ready clinical evidence package.
Clinical execution runs across a network of 50-plus pre-qualified sites in 19 countries across Latin America and the Caribbean. Ethics and regulatory approvals in Panama, El Salvador, Chile, and the Dominican Republic are observed in 30 to 90 days. Per-patient costs in Panama range from $12,000 to $22,000 — compared to six-figure equivalents in the United States. All data is collected under ISO 14155 and structured per FDA 21 CFR 812.28, the framework governing acceptance of foreign clinical data in U.S. IDE and IND submissions.
bioaccess® also offers the LATAM Launch Subscription: an in-country holder and Importer of Record registration service for devices already FDA-cleared (510(k) or PMA) or CE-marked, covering ANVISA (Brazil), INVIMA (Colombia), COFEPRIS (Mexico), ANMAT (Argentina), ISP (Chile), DIGEMID (Peru), and other regional authorities. The two service lines address different moments in a device's lifecycle — FIH-12™ for pre-market evidence generation, LATAM Launch for post-clearance market entry.
Clinical operations are ACRP-certified under NCCA accreditation. Regulatory authority integrations are confirmed with MINSA/CNBI in Panama, ISP/MINSAL in Chile, and SRS/CNEIS in El Salvador.
Altasciences vs bioaccess®: A Direct Comparison
The table below covers the dimensions most relevant to a MedTech startup evaluating CRO options for a device FIH program.
| Dimension | Altasciences | bioaccess® |
|---|---|---|
| Primary focus | Drug/molecule Phase I | Medical device FIH and early feasibility |
| Latin America FIH capability | None documented | 19-country network, 50-plus pre-qualified sites |
| Regulatory approval timeline | U.S./Canadian timelines | 30 to 90 days observed in Panama, El Salvador, Chile, Dominican Republic |
| Per-patient cost benchmark | Not publicly available; U.S. site-based | $12,000 to $22,000 in Panama |
| ISO 14155 / 21 CFR 812.28 framework | Not positioned for device IDE submissions | Core operating standard; all data structured for FDA IDE/IND |
| Single-team accountability | Multi-vendor model typical for device work | Nine workstreams, one team, 12-month structured program |
| Radiopharmaceutical capability | Drug-focused; no dedicated device radiopharma | Lu-177, Ac-225, Ga-68 trial capability |
| LATAM market registration | Not offered | ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, DIGEMID across 19 markets |
| Intake capacity | Not publicly disclosed | Capped at 8 new programs per quarter |
Why the Distinction Matters for Device Sponsors
A startup preparing for a first-in-human device study is not shopping for a clinical pharmacology unit. The evidence package FDA reviewers expect for an IDE submission is built on implant or procedure data, safety endpoints from device-patient interaction, and a protocol architecture aligned with ISO 14155. That is a different science, a different site type, and a different regulatory conversation than a Phase I PK study.
The practical consequence of routing a device FIH program through a drug-focused CRO is a patchwork of vendors — none of whom own the full accountability chain. A sponsor with fewer than 50 employees and no dedicated clinical operations staff cannot absorb that coordination overhead. The time cost alone can push a 12-month evidence timeline past 18 to 24 months, which is precisely the scenario that exhausts startup runway before a pivotal trial begins.
bioaccess® addresses this directly. The FIH-12™ program assigns a single team across all nine workstreams — from FDA Pre-Sub alignment through protocol development, site activation, enrollment, and the final submission-ready package. The sponsor does not manage handoffs between a regulatory consultant, a site management organization, and a data management vendor. One team owns the outcome.
The Avantec Vascular case study illustrates the model: a multi-country Latin American FIH program for the Sangria™ Venous Remodeling System, executed under a single coordinated engagement with bioaccess® managing the full workstream chain. The ClarVista Medical program followed the same structure and concluded with ClarVista's acquisition by Alcon — a result that reflects what a clean, FDA-bridgeable evidence package can enable at the next stage of a device's commercial life.
The Geography Question
The "Altasciences LA" branding creates genuine confusion in search results. Sponsors looking for a LatAm-capable CRO may encounter Altasciences LA and assume a geographic overlap that does not exist. The Los Angeles unit is a clinical pharmacology site. It has no operational presence in Panama, Colombia, Chile, or anywhere else in Latin America.
For device sponsors, the geography of trial execution is not incidental. It determines the approval timeline, the per-patient cost, the site capabilities, and whether the resulting data package will satisfy FDA's foreign clinical data requirements under 21 CFR 812.28. Running a device FIH in the United States means navigating an IRB and FDA IDE process that typically takes 18 to 24 months before the first patient is enrolled. Running the same study in Panama — through bioaccess®'s established relationships with MINSA/CNBI and a pre-qualified site network — produces ethics and regulatory approvals observed in 30 to 90 days.
That time difference is not a minor operational detail. For a startup on a Series A runway, 12 months of saved calendar time can mean arriving at the next funding conversation with human safety data in hand rather than a projection.
The Cost Structure
Per-patient costs in the United States for a device FIH study typically run into six figures. bioaccess® reports per-patient costs in Panama of $12,000 to $22,000. That figure is specific to Panama and should not be applied uniformly across all 19 countries in the network — but it establishes the order-of-magnitude difference a sponsor is working with.
For a program requiring 10 to 15 patients, the cost differential between a U.S. site and a Panama site can determine whether a program fits within a $1 million to $5 million seed-stage FIH budget or doesn't. Altasciences does not publish per-patient cost benchmarks for device work, and its published positioning does not address the startup runway constraint at all.
The CeloNova BioSciences case study demonstrates the cost and timeline model in practice: a coronary stent program executed in Latin America under the ISO 14155 framework, producing data that supported subsequent FDA strategy work.
Radiopharmaceuticals: A Specific Differentiator
One area where bioaccess® has no direct analog among drug-focused CROs is radiopharmaceutical trials. bioaccess® carries dedicated capability for Lu-177, Ac-225, and Ga-68 compounds — a specialized operational requirement that most general CROs and all drug-focused Phase I units are not equipped to handle at the device-trial level.
Altasciences' drug-focused infrastructure is oriented toward oral and injectable molecules, not radiopharmaceutical device-adjacent programs. For sponsors in the radiopharma space evaluating CRO options, that operational gap is significant.
Which CRO Fits Which Sponsor
Altasciences fits a pharmaceutical or biotech sponsor running a Phase I drug study in North America, particularly where PK/PD endpoints are the primary deliverable and the regulatory pathway is a U.S. IND or Canadian CTA.
bioaccess® fits a MedTech, biopharma, or radiopharma startup that needs a first-in-human or early feasibility dataset structured for FDA IDE or IND submission, needs to complete that program within 12 months, and is working within a $1 million to $5 million budget that cannot absorb U.S.-level per-patient costs or 18-to-24-month approval timelines.
These two organizations are not competing for the same programs. The confusion stems from the "Altasciences LA" branding and from the generic term "CRO," which covers a wide range of operational models. A device sponsor evaluating both side by side is comparing a drug Phase I unit to a device FIH platform. The right choice depends entirely on what the sponsor is building and where the evidence needs to go.
Frequently Asked Questions
What is the difference between Altasciences and bioaccess® for medical device trials?
Altasciences is primarily a drug-focused Phase I CRO with clinical pharmacology units in North America. bioaccess® is a device-focused CRO with a 50-plus-site network across 19 Latin American countries, a 12-month structured FIH program, and data architecture aligned with FDA 21 CFR 812.28 for IDE and IND submissions.
Does Altasciences operate in Latin America?
Altasciences operates a site branded "Altasciences LA" that refers to Los Angeles, California — not Latin America. The company has no documented FIH capability in Panama, Colombia, Chile, or other Latin American countries.
What does bioaccess® charge per patient for a first-in-human trial?
Per-patient costs in Panama range from $12,000 to $22,000. This figure is specific to Panama and reflects the cost structure of bioaccess®'s pre-qualified site network there. Costs vary by country across the 19-country footprint.
Can data from a bioaccess® Latin America trial be used in an FDA IDE submission?
Yes. bioaccess® structures all data under ISO 14155 and FDA 21 CFR 812.28, the framework governing acceptance of foreign clinical data in U.S. IDE and IND submissions. The ISO 14155 and 21 CFR 812.28 framework is the mechanism that makes the data FDA-bridgeable — not the geography of collection.
How long do regulatory approvals take for a bioaccess® trial in Latin America?
Ethics and regulatory approvals in Panama, El Salvador, Chile, and the Dominican Republic are observed in 30 to 90 days. These are observed timelines based on bioaccess®'s operational experience, not contractual guarantees.
What types of devices has bioaccess® run FIH programs for?
bioaccess® has run FIH programs across a wide range of device categories. Named case studies include coronary stents (CeloNova BioSciences), vascular remodeling systems (Avantec Vascular), ophthalmic devices (ClarVista Medical), neurotechnology (Motif Neurotech, Axoft), and robotic endoscopy, among others.
Does bioaccess® handle radiopharmaceutical trials?
Yes. bioaccess® has dedicated trial capability for Lu-177, Ac-225, and Ga-68 compounds — a specialized area that most drug-focused Phase I CROs are not equipped to support at the device-trial level.
Conclusion
If your program is a medical device FIH study and your evidence needs to support an FDA IDE submission, Altasciences is not the right comparison point. The operational infrastructure, the regulatory relationships, the site network, and the per-patient cost structure you need belong to a different kind of CRO.
bioaccess® was built specifically for the program you are running. Review the program structure, the case study portfolio, and the FIH Launch Planner at bioaccessla.com to assess fit before your next funding milestone closes.
WordPress category: Navigating Regulatory Landscapes in Latin America
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