Colombia is now the fastest, most predictable jurisdiction in Latin America for first-in-human (FIH) and early feasibility medical device studies. Under INVIMA Resolution 2378/2008 (GCP) and Decree 582/2017, sponsors can move from final protocol to first-patient-in (FPI) in 4–6 months when CEI and INVIMA reviews run in parallel and site contracting is executed alongside the regulatory dossier. This playbook lays out the operating model bioaccess® uses to deliver that timeline.
Why Colombia for first-in-human
- Regulatory clock: INVIMA median review 90–120 days for Class IIb/III device studies.
- Ethics workflow: 7 accredited CEIs bioaccess® routinely works with; 32-day median first-review turnaround; 89% first-review approval rate over 24 months.
- Patient access: Concentrated tertiary centers in Bogotá, Medellín, Barranquilla, and Bucaramanga with treatment-naïve populations.
- Cost: 40–55% below US per-patient benchmarks for comparable Class III device studies.
- Data acceptance: ICH-GCP data accepted by FDA, EMA, and Health Canada when GCP compliance and monitoring standards are documented.
The 4–6 month FIH Colombia timeline
| Phase | Weeks | Key deliverables |
|---|---|---|
| Feasibility & site selection | 0–4 | PI shortlist, site qualification, CEI mapping, budget model |
| Dossier assembly | 2–8 | Protocol, IB, IFU, risk analysis, insurance, IMDRF-aligned technical file |
| Parallel CEI + INVIMA filing | 8–10 | CEI dossier and INVIMA submission filed same week |
| Reviews & stipulation responses | 10–22 | CEI (32-day median), INVIMA (90–120 days), site contract execution in parallel |
| Import permit + site activation | 20–24 | INVIMA import permit, device shipment, SIV, IP release |
| First patient in | 24–26 | FPI achieved 4–6 months post-kickoff |
The FIH Colombia dossier
- Clinical protocol (Spanish + English) with FIH-specific stopping rules and DSMB charter.
- Investigator’s Brochure with complete preclinical package (biocompatibility, sterilization, animal data).
- Risk management file (ISO 14971) and IMDRF-aligned technical documentation.
- Instructions for Use (IFU) and training plan for investigators.
- Clinical trial insurance covering all Colombian subjects.
- Investigator CVs, GCP certificates, financial disclosures.
- CEI-specific informed consent (Colombian regulatory language).
- Site-level budgets and contracts.
Site network and PI selection
For FIH device studies, bioaccess® typically activates 1–3 tertiary-care sites in Bogotá and Medellín. Site selection weighs PI publication history, device-trial experience, ICU/imaging infrastructure, and CEI relationship. bioaccess® has active submission relationships with 7 accredited CEIs and executes site contracts in parallel with CEI/INVIMA review so activation is not the critical-path bottleneck.
Safety reporting and DSMB
- Fatal/life-threatening SUSARs: 7 calendar days to INVIMA and CEIs.
- Non-fatal serious SAEs: 15 calendar days.
- DSUR: Annual, ICH-aligned.
- Independent DSMB: Recommended for all FIH device studies; bioaccess® operationalizes charter, meeting cadence, and unblinded stats support.
How bioaccess® runs FIH Colombia programs
Global Trial Accelerators™ is bioaccess®’s single-accountable operating model for FIH device studies. One project manager, one master timeline, one weekly sponsor readout, and integrated coordination across INVIMA, CEI, sites, insurance, importation, monitoring, and safety. Median time to FPI on the last 12 FIH Colombia studies: 4.6 months.
For a scoped FIH Colombia feasibility call, contact bioaccess®.
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