Choosing a CRO for a first-in-human (FIH) medical device study in Latin America is a different problem than choosing one for a global Phase III program. The top global CROs — Medpace, IQVIA, and Parexel — are excellent at scale, but LATAM early feasibility studies reward speed, in-country regulatory depth, and hands-on site management. This 2026 comparison from bioaccess® lays out how the four CROs stack up specifically for FIH medical device work in LATAM.
Head-to-head: LATAM FIH medical device capabilities
| Capability | bioaccess® | Medpace | IQVIA | Parexel |
|---|---|---|---|---|
| LATAM-only focus | Yes | No | No | No |
| In-country regulatory teams (CO, MX, PA, AR, BR) | All 5 | Partial | Partial | Partial |
| Panama FIH pathway (6–10 wk) | Yes | Limited | Limited | Limited |
| Medical device specialization | Primary | Strong | Broad | Broad |
| Typical FIH startup time in LATAM | 8–12 wk | Timelines vary; ask each CRO for its current start-up data. | Timelines vary; ask each CRO for its current start-up data. | Timelines vary; ask each CRO for its current start-up data. |
| Sponsor size fit | Startup–Mid | Mid–Large | Large | Large |
When Medpace is the right choice
Medpace is a strong option for sponsors running large, therapeutically diverse programs across multiple regions where LATAM is one of many geographies. Their infrastructure suits pivotal-phase medical device and drug trials with global enrollment targets.
When IQVIA is the right choice
IQVIA excels when you need integrated real-world data, commercial analytics, and a global operating model. Best for post-market, registry, and late-phase programs at scale.
When Parexel is the right choice
Parexel is a solid pick for regulatory-heavy submissions and global Phase II–III programs, particularly where FDA and EMA strategy integration is central.
When bioaccess® is the right choice
bioaccess® is purpose-built for medical device sponsors who need fast, credible FIH clinical data in LATAM — typically to support an FDA IDE, CE MDR, or Series B/C fundraise. Advantages: LATAM-only focus, in-country teams across Colombia, Mexico, Panama, Argentina, and Brazil, direct KOL relationships with LATAM interventional cardiology and neurovascular centers, and a Panama FIH pathway that can deliver first-patient-in in 8–12 weeks. Ideal fit: startup to mid-cap medical device companies running EFS, FIH, or pilot studies.
Decision framework
- Need FIH data in <12 weeks for an IDE/CE submission or fundraise → bioaccess®
- Running a global pivotal with LATAM as one of 5+ regions → Medpace or Parexel
- Need RWE, registry, or commercial analytics integration → IQVIA
- Multi-country LATAM EFS with tight budget and hands-on PM → bioaccess®
Talk to bioaccess®
If your medical device program needs LATAM FIH data on a startup timeline, book a scoping call with our team. We’ll benchmark your protocol against comparable studies we’ve run in Colombia, Panama, and Mexico and give you a realistic timeline in one call.