Medical Device Clinical Trial Site Selection and Study Approval in Colombia
Interventional Concepts can assist with the search, site selection, and approval of your medical device study in Colombia. We will review your site selection criteria or site pre-qualification form and study goals. Then, we will search the 100+ clinical research sites in Colombia that are ICH-GCP (certified by Colombia's regulatory agency, INVIMA) to find the ideal site and principal investigator for your medical device clinical trial. We will then get the study approved at the site's ethics committee, and then we will get it approved at Colombia's Ministry of Health's medical device regulatory agency (INVIMA). Once we get your study approved, we will then get your import permit approved so that you can ship your investigational devices to your site in Colombia.
This offering includes,
- One-hour session with sponsor to review clinical goals, answer clinical and operational questions, and to formulate a strategy for its trial in Colombia.
- Review of sponsor's trial readiness (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.
- Protocol review, identification of schedule of events, creation of budget template.
- 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 of protocol.
- Session(s) with site(s) to answer questions about the trial to create draft trial budget(s).
- Budget negotiation and interactions with medical and administrative staff at sites to negotiate and finalize budget(s).
- Coordination and participation in introductory conference call with selected site(s) and sponsor.
Study Approval (medical devices)
- 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 $1,000).
- Submission of protocol application to INVIMA: Includes completing application, editing of study documents to comply with INVIMA's guidelines, and final assembly (excludes submission fee of about $1,000).
- Submission of 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.
*50% payable upon receipt of invoice, and remaining 50% payable upon selection of your site. Limited to finding one (1) site in Colombia. We will add a a 15% administrative fee to any third-party payments. Excludes travel-related expenses (e.g. airfare, lodging, ground transportation, meals, etc.). Excludes IRB and INVIMA submission fees. When applicable, we will add a 16% sales tax charge to pass-through expenses. If sponsor requires it, we will translate study documents into Colombian Spanish and will invoiced them based on the total number of words in Spanish at the rate of USD 0.25 per word in Spanish. Sponsor will need one import permit submission for each shipment to a site in Colombia. Additional import permit application submissions will be billed at $700 per shipment. Duration (approx.): 30-45 days for site selection and about 30-45 days for INVIMA approval.