Clinical Trial Site Selection, Set-Up and Approval in Colombia

 
 TRIALREADY℠_Medical device clinical trial site selection in Colombia
 

Clinical Trials in Colombia

We are a contract research organization (CRO) in Colombia and can assist you with the search, site selection, and approval of your planned clinical trial in Colombia. We will review your site selection criteria and study goals. Then, we will 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 for your clinical trial. We will then get the study approved at the site's institutional review board (IRB, or ethics committee), and then we will get it approved at INVIMA. The next step is to obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia. Please be aware Colombian regulations prevent healthy volunteers from participating on Phase I trials; only sick patients with the disease related to the therapeutic area of your investigational products are allowed. 

Approval Requirements

  • Medical devices: See here
  • Pharmaceutical drugs: See here
  • Biotechnology drugs, gene therapy, tissue regenerating technologies, and other biotech products that are not classified as medical devices or pharmaceutical drugs do not need INVIMA approval; only ethics committee approval is necessary. 

Read the FAQ here

 

Trial Site Selection in Colombia

USD 3,499*

  1. One-hour session with 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 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 site(s) to answer questions and create 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 introductory conference call with selected site(s) and sponsor. 

Trial Set-Up and Approval in Colombia

USD 14,999*

  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 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. 

We also offer study design, study/project management, study monitoring, trial close-up, and other related offerings in Colombia. Ask us about it

Notes(*):

  • 50% payable upon receipt of invoice, and remaining 50% payable upon selection of your site.
  • Limited to finding one (1) site in Colombia.
  • Excludes a 20% 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.
  • Excludes translations to Spanish. 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.
  • Excludes submission of subsequent import permit applications to Colombia's Ministry of Commerce, Industry and Tourism. Sponsor will need one import permit submission for each shipment to a site in Colombia, and every import permit application submission will be billed per shipment.
  • Excludes technovigilance post-approval trial reporting requirements to IRB and INVIMA. Duration (approx.): 30-45 days for site selection and about 30-45 days for INVIMA approval.
  • Excludes registered agent/legal representation services in Colombia

Terms and Conditions

 
 

 
Colombia clinical trial guide-steps to approve a clinical trial.png

6 STEPS TO APPROVE YOUR CLINICAL TRIAL IN COLOMBIA

learn the regulatory pathway to GET YOUR clinical trial APPROVED in colombia

 

 
 

 
 
Colombia has a well-established legal framework and is currently one of the fastest-growing countries for clinical trials and the approval timelines also at 3-4 months. Since 2008, a new bylaw has established that research sites must be certified by Colombia’s regulatory agency INVIMA to conduct clinical studies, which caused some additional work, but also increased the quality standards of the accredited sites.
— Pharmaceutical Outsourcing, 2011