Medical Device First-in-Man Clinical Trial Approval in Colombia
Medical Device First-in-Man Clinical Trial Approval in Colombia
$19,999.00
Get your research site activated and your medical device first-in-man clinical trial quickly approved at the IRB/EC and the Ministry of Health (INVIMA) in Colombia. Start collecting your clinical data in Colombia now.
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:
- 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.
- We will put together the dossier package to get the study approved at the site's institutional review board (IRB) or ethics committee(EC).
- We will get your trial approved at INVIMA.
- 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
- 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.
- Review of study documents (i.e. study protocol, patient informed consent, investigator's brochure, lab tests, etc.).
- Recommendations to successfully creating a clinical trial regulatory, clinical, and operational strategy in Colombia.
- Creation of study budget template.
- Review of the patient population, searching, conducting due diligence, and selecting site(s) and principal investigator(s).
- Interviews with candidate site(s) and principal investigators.
- NDA signing with candidate site(s) and principal investigators, sharing and explanation of protocol.
- Meetings with the site to answer questions and to create the trial budget.
- Budget negotiation and interactions with medical and administrative staff at sites to negotiate and finalize budget(s).
- Gathering of candidate investigators' CVs, summarization, and presentation to sponsor.
- Coordination and participation in the introductory conference call with the selected site(s) and sponsor.
Start-Up and Approval (IRB/EC and INVIMA)
- Coordination and attendance of sponsor pre-trial visit in Colombia.
- Coordination and execution of the clinical trial agreement (CTA provided by sponsor).
- 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).
- 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).
- 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).
- Submission of one (1) import permit application to Colombia's Ministry of Industry, Commerce, and Tourism.
- 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.