RARAS CRO is one of the few homegrown Latin American firms that publicly positions itself as a medical-device CRO, not only a drug shop with a devices footnote. That makes it a real name on a MedTech shortlist. It does not make it the same product as a first-in-human / early-feasibility (FIH/EFS) specialist that anchors the protocol to FDA from Miami and executes through its own local entities — including Colombia — as a dedicated implant operating system.
This is a practitioner comparison, not a takedown. Facts about RARAS come from rarascro.com, who-we-are, and our-services, retrieved 23 August 2026. Where a figure is a company claim, it is labeled as one.
What RARAS CRO publishes
RARAS describes itself as “the next generation of clinical research in Latin America,” with a bench-to-bedside platform spanning product development, clinical research (Phase I–III), and real-world evidence. The home page states that RARAS is “the first CRO in Latin America to have distinctive teams focusing on the specificities of MedTech and Pharma.” The MedTech tile carries the line “RARAS is the #1 CRO in Latin America in Medical Devices” — that is a company claim, not an independently audited ranking, and it is treated as such here.
The origin story on the site is specific. RARAS was “born from the merger of EUGEN, the only CRO in Uruguay, and an experienced team trained by CRC (Cardiovascular Research Center), the largest medical device CRO in Brazil.” A 2020 timeline item says two leading investigation groups merged to found RARAS with offices in Uruguay, Brazil, and Panama. The Peru office opened in 2020. Medical writing was added in 2022; a data-management team in 2023. In 2023 the company “consolidates presence in LATAM and opens its own operations in Argentina, Chile, Colombia.” The published office list is Argentina, Brazil, Colombia, Chile, Panama, and Uruguay.
Client geography is listed as countries, not logos: Austria, Brazil, Canada, China, Germany, Israel, Ireland, France, Sweden, Switzerland, and the USA. No named sponsors appear on the public pages reviewed. The pharma side of the home page states that the team “has conducted over 240 projects in 9 countries in Latin America” — again, a company claim.
A Healthtech Colombia member listing has been cited in industry maps as saying RARAS accounts for “más del 70% de todos los estudios clínicos con dispositivos en Brasil.” That sentence is a company / directory claim. It is not treated as an independently verified market share in this article.
Leadership published on the who-we-are page includes Claudia Rodriguez Verde, Co-Founder & CEO (former CEO / Director roles at Quintiles / IQVIA for Brazil, Colombia, and Uruguay); Leonardo Abizaid, Co-Founder, Director of Business Development and Medical Affairs (former COO of CRC since 2007, cardiovascular-device portfolio described in qualitative terms); Sandra Facincone, Co-Founder & Director of Clinical Development; and Marisa Sanvito, MD, MBA, Director of Clinical Operations. Jaqueline Reis leads Medtech regulatory and Brazil ethics submissions. Carolina Duque is named Quality Assurance Manager and as representing RARAS on the board of Avanzar in Colombia.
Services published: feasibility and regulatory-agent work; Phase I–IV trial execution (start-up, monitoring, site management, project management, SAE/safety, data management); post-marketing registries, compassionate use, RWE; medical writing (protocols, IB, CSR, DSUR, publications); and a product-development launch platform that names Phase I–FIM through Phase III and post-market. The services page says the suite has “in-depth expertise in medical device trials” and that data can be used for FDA, EMA, ANVISA, and other agency purposes — as a capability statement, not as a named clearance.
What that profile is good at — and what it is not
On the public record, RARAS is a Brazil-centric, full-service regional CRO with a genuine MedTech story (CRC cardiovascular-device legacy + a dedicated MedTech regulatory lead in Brazil) and a growing Andean/Southern Cone office list. That is a credible vendor for later-phase or multi-country LATAM device work when the sponsor already has a protocol, a regulatory strategy, and a U.S. agent — or when the job is ANVISA-heavy cardiovascular device research inside Brazil.
It is a weaker match when the job is the first five-to-thirty implants of a U.S. startup device, designed from a Pre-Sub, executed under ISO 14155, imported into one or two fast LATAM sites, and packaged as an English 21 CFR 812.28 data room. That job is not “Phase I–III plus a MedTech team.” It is a different product: small n, high touch, FDA-facing, multi-entity, often multi-country, with a Miami counterpart who sits in the diligence call.
RARAS does not, on the pages reviewed, publish a named EFS, a named investigational implant, or a named U.S. startup case. Absence of a logo wall is not proof the work was never done. It is proof a sponsor cannot diligence FIH device depth from the public site alone.
What bioaccess® is selling instead
bioaccess® is The First-in-Human CRO — built for the U.S. and Latin America. Co-founded in 2010 by Dr. Pedro Martinez-Clark, Dr. William O’Neill, and Julio G. Martinez-Clark (CEO). Legal entity IMH ASSETS CORP. Headquarters at 1200 Brickell Ave, Suite 1950 #1034, Miami, FL 33131. Regional offices in Bogotá, Mexico City, Santiago, São Paulo, and Buenos Aires. FIH-only focus since 2010. U.S. regulatory anchoring (FDA Pre-Sub, IND/IDE) plus Latin American execution. ISO 14155 for devices; ICH E6 for drugs. 50+ pre-qualified sites across 19 countries; 50+ FIH/EFS studies supported; 50+ client companies served (company about page).
Colombia is not a flag on a map. bioaccess® still runs clinical trials in Colombia, keeps a local Colombian entity and office, manages INVIMA clocks in-country, and has 30+ historical FIH device studies and 20+ sites across Bogotá, Cali, Medellín, and Barranquilla. INVIMA is a PAHO/WHO Level 4 authority. Commercial registro sanitario is a separate live service through bioaccess®’s own in-country entities. See CRO in Colombia and CRO en Colombia.
The product difference is structural. RARAS is a regional full-service house with MedTech and pharma benches. bioaccess® is a specialist FIH/EFS house with a U.S. headquarters, local LATAM entities, and a registration arm that can hold the device after the trial. A U.S. founder buying the second product and receiving the first will feel the gap at Pre-Sub, at import, and at the first investor data room.
RARAS CRO vs bioaccess® — FIH device comparison
| Dimension | RARAS CRO | bioaccess® |
|---|---|---|
| Public origin | Merger of EUGEN (Uruguay) and CRC-trained device team (Brazil) | Co-founded 2010, Miami; Colombian roots + local CO entity |
| Published offices | AR, BR, CO, CL, PA, UY; Peru office 2020 | Miami HQ; Bogotá, Mexico City, Santiago, São Paulo, Buenos Aires; 19-country network |
| Device claim | “#1 CRO in Latin America in Medical Devices” — company claim | FIH/EFS device specialist since 2010; 30+ historical FIH device studies |
| Brazil device share | Healthtech Colombia “70% of Brazil device studies” — company/directory claim, not treated as fact | Not a Brazil-share claim; multi-country FIH network |
| Named sponsors on public site | None; client countries listed | Published case studies on bioaccessla.com |
| Named device EFS / implant protocols | None on public site; CRC legacy described qualitatively | FIH/EFS is the core published product |
| Leadership (public) | Claudia Rodriguez Verde, CEO; Leonardo Abizaid, BD/Medical Affairs; Sandra Facincone; Marisa Sanvito, ClinOps | Julio G. Martinez-Clark, CEO; Pedro Martinez-Clark, CMO; William O’Neill, Medical Director |
| FDA-facing operating model | Capability language for FDA/EMA/ANVISA-usable data; not a Pre-Sub / 812.28 product page | Pre-Sub, IDE/IND planning, 812.28-ready English data room |
| Colombia | Own operations opened 2023 (company timeline) | Trials since 2010; local entity; INVIMA clocks in-country; still executing |
| After the trial | RWE / post-market listed | Live LATAM sanitary registration / holder service |
How a U.S. sponsor should diligence RARAS on a device FIH RFP
Invite RARAS if Brazil cardiovascular device depth or a full-service LATAM pharma/device mix is in scope. Then ask questions the public site cannot answer:
- Name (or de-identify) an investigational-device FIH or EFS: class, implant vs. diagnostic, n, countries, whether an English TMF was delivered, and whether the data were used in an FDA file.
- Who is the legal representative and importer in each country you need — Colombia included — and is that RARAS’s own entity or a third party?
- Who authors the FDA Pre-Sub / IDE-facing protocol language, and where do those people sit?
- How is the MedTech bench staffed versus the pharma bench on a 15-patient implant? Full-service CROs staff to the larger contract.
- What is the path from last patient to sanitary registration if the same partner is expected to hold INVIMA / ANVISA / COFEPRIS?
If the answers are strong, RARAS can be a regional peer for later work. If the answers are capability language, the sponsor still needs a dedicated FIH CRO. That is the lane bioaccess® occupies. Proposal path: contact.
FAQ — RARAS CRO and LATAM MedTech FIH
Is RARAS the #1 MedTech CRO in Latin America?
RARAS states that on its home page. Treat it as a company claim. No public, independently audited ranking was used for this article.
Did RARAS run 70% of device studies in Brazil?
That figure appears as a company / Healthtech Colombia directory claim. It is not treated as verified market share here.
Does RARAS have a Colombia office?
The company timeline says own operations in Colombia opened in 2023, and Colombia is on the office list. That is younger than bioaccess®’s Colombia practice (2010–present, still active).
Are there named RARAS device sponsors?
Not on the public site reviewed 23 August 2026. Client countries are listed; logos and protocol names are not.
When is bioaccess® the better prime?
When the milestone is a U.S. startup’s first implant or EFS, FDA-facing, small n, with local entities and the option to add countries — and when commercial registration should stay with the same partner. Start at CRO in Colombia if Colombia is on the map.
Competitor facts from rarascro.com (home, who-we-are, our-services), 23 August 2026. bioaccess® facts from bioaccessla.com/about, first-in-human-cro, market-access, and the Colombia pillars. No invented stats, emails, sponsor names, or day-count medians.