From site selection to regulatory mastery — bioaccess® has managed one of Colombia's most complex, longest-running FIH vascular device studies for Cook Advanced Technologies and MED Institute.
Cook Advanced Technologies, a division of Cook Medical — one of the world's largest family-owned medical device companies — engaged MED Institute, Inc. as their clinical research partner to execute a first-in-human early feasibility study of a novel Artificial Venous Valve in Colombia. The study targeted patients with deep venous insufficiency, a serious and undertreated vascular condition. The challenge was substantial: Colombia's INVIMA regulatory framework for investigational devices requires meticulous, ongoing regulatory management including multi-site Ethics Committee submissions, annual insurance policy renewals, device importation permits, INVIMA audits, site improvement plans, and annual reporting — all while managing up to four simultaneous investigational sites and a patient population requiring long-term follow-up.
MED Institute selected bioaccess® as their in-country CRO to manage the full Colombia clinical trial operations. bioaccess® was engaged via Work Order No. 01, executed October 29, 2021, to deliver end-to-end CRO services from site selection through regulatory management and study monitoring. Amendment No. 01 was executed on February 22, 2022, expanding the scope. By 2026, the relationship had grown into one of bioaccess®'s most complex and enduring CRO partnerships, with Amendment No. 02 proposed in March 2026 to address the expanded regulatory workload generated by INVIMA site audits and improvement plan requirements. **Phase 1 — Site Search & Selection (2021):** Full site qualification process across Colombia's vascular surgery programs. Selection of principal investigators and sites. Introductory and follow-up meetings between MED Institute and site PI teams. NDA execution. Final site budget negotiation. **Phase 2 — Trial Set-Up & Start-Up (2021–2022):** Epidemiological and regulatory review of all study documents (protocol, informed consent, investigator's brochure, biocompatibility data). Study budget template creation and negotiation. Document collection and organization. Gantt chart and project timeline development. Supporting documentation drafting. Clinical Trial Agreement coordination and execution with sites. Initial EC submissions per Colombian Resolución 8430 de 1993. Initial INVIMA submission and approval. Site Initiation Visits. Trial Master File setup and management. SARLAFT anti-money laundering compliance forms. Device importation permits (MinCIT) and customs nationalization (DIAN). Registered Agent / Legal Representation in Colombia. **Phase 3 — Ongoing Study Management (2022–2026):** Monthly study management covering all enrolled and non-enrolling sites. Monitoring visits (IMVs). INVIMA annual reports, device usage reports, and deviation quarterly reports. Multi-site Ethics Committee submissions and follow-ups. SAE identification, reporting to EC and INVIMA, and clinical follow-up. Insurance policy renewals — including complex multi-site EC resubmissions of updated insurance certificates. **Phase 4 — Regulatory Complexity Management (2025–2026):** As the study matured, INVIMA's audit activity generated new requirements: formal site improvement plans for each audited site, increasing regulatory filings from 9 (2022) to 57 (2025), and coordination of insurance policy submissions across four sites with staggered Ethics Committee timelines. bioaccess® managed the complete INVIMA submissions log (142 total filings through March 2026) and proposed Amendment No. 02 to align the contractual scope with the actual regulatory workload.
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