First-in-Man Clinical Trial Site Selection, Set-Up, and Approval

We are a US-based contract research organization (CRO) that focuses on Colombia. We can assist you with the search, site selection, and approval of your planned early-stage/early feasibility/first-in-man (FIM)/first-in-human (FIH)/pilot/concept/clinical trial in Colombia.

There are four steps for us to get your trial approved in Colombia:

1. We will review your site selection criteria and study goals. We will then search the 110+ clinical research sites in Colombia that are ICH-GCP (certified by Colombia's regulatory agency, INVIMA) to find the ideal site and principal investigator that matches your study.
2. We will put together the dossier package to get the study approved at the site's institutional review board (IRB) or ethics committee(EC).
3. We will get your trial approved at INVIMA.
4. We will obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia.

Note: Please be aware Colombian regulations prevent healthy volunteers from participating in phase I trials; only sick patients with the disease related to the therapeutic area of your investigational products are allowed. 

Site Selection

1. One-hour session with the sponsor to review clinical goals, answer clinical and operational questions, and to formulate a strategy for its trial in Colombia.
2. Review of study documents (i.e. study protocol, patient informed consent, investigator's brochure, lab tests, etc.).
3. Recommendations to successfully creating a clinical trial regulatory, clinical, and operational strategy in Colombia. 
4. Creation of study budget template. 
5. Review of the patient population, searching, conducting due diligence, and selecting site(s) and principal investigator(s).
6. Interviews with candidate site(s) and principal investigators.
7. NDA signing with candidate site(s) and principal investigators, sharing and explanation of protocol.
8. Meetings with the site to answer questions and to create the trial budget.
9. Budget negotiation and interactions with medical and administrative staff at sites to negotiate and finalize budget(s).
10. Gathering of candidate investigators' CVs, summarization, and presentation to sponsor. 
11. Coordination and participation in the introductory conference call with the selected site(s) and sponsor. 

Start-Up and Approval (IRB/EC and INVIMA)

1. Coordination and attendance of sponsor pre-trial visit in Colombia.
2. Coordination and execution of the clinical trial agreement (CTA provided by sponsor).
3. Gathering, reviewing of sponsor's study documents (protocol, investigator's brochure, insurance policy, principal investigator (PI) training certification, and additional supporting documentation as required for approval). 
4. Submission of protocol application to site's ethics committee (EC): Includes gathering of local EC requirement checklist, editing, and assembly of submission package (excludes submission fee of about USD1,000). 
5. Submission of protocol application to INVIMA: Includes completing the application, editing of study documents to comply with INVIMA's guidelines, and final assembly (excludes submission fee of about USD1,000).
6. Submission of one (1) import permit application to Colombia's Ministry of Industry, Commerce, and Tourism.
7. Coordination and attendance of site initiation visit and training to site's PI, study coordinator, and relevant staff. 

Approval Requirements

Read the INVIMA requirements and meeting dates for first-in-man clinical trials involving medical devices: See here.