Medical Device First-In-Human Clinical Trial Approval in Colombia
Get your research site activated and your medical device first-in-human 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-Human Clinical Trials in Colombia
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)/proof-of-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 your study submitted at the site's institutional review board (IRB) or ethics committee(EC).
We will put together the dossier package to get your study submitted at INVIMA.
We will obtain an import permit approved so that you can ship your investigational medical products to your site in Colombia.
We can also provide study management, monitoring, and other services related to making sure your trial is a success in Colombia.
Sessions with the sponsor to review clinical goals, answer clinical and operational questions, and to formulate a strategy for its clinical trial in Colombia.
Review of study documents (i.e. study protocol, patient informed consent, investigator's brochure, lab tests, etc.).
Search for potential sites/investigator at the national patient registry database at Colombia's Ministry of Health*
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.
*bioaccess.™ is the only CRO in company in Colombia that licenses and has exclusive access to a patented algorithm to do data mining, business analytics and visualization of the national government-sponsored patient registry managed by the Ministry of Health. This patient registry covers over the 94.8% of the Colombian population that is part of the country’s universal healthcare system. With this software, bioaccess.™ can determine —among other things— the number of patients for a determined condition/disease, what drugs they take, what medical procedures they underwent, and in what specific hospital(s) patients are been treated. This significantly speeds up and facilitates the site selection process, and patient research and recruitment.
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).
Gathering, reviewing study documents: Protocol, investigator's brochure, insurance policy, principal investigator (PI) training certification, and additional supporting documentation as required for approval.
Study submission to the site's ethics committee (EC): Includes gathering of local EC requirement checklist, editing, and assembly of submission package (excludes applicable submission fee).
Study submission to INVIMA: Includes completing the application, editing of study documents to comply with INVIMA's guidelines, and final assembly (excludes applicable submission fee).
Submission of one (1) import permit application to Colombia's Ministry of Industry, Commerce, and Tourism (MinCIT).
Coordination and attendance of site initiation visit and training to site's PI, study coordinator, and relevant staff.
We will assist you in submitting your medical device study protocol approval application. Our product development team can also assist you in designing your human study and in creating the necessary documents for submission to INVIMA. Our US and Colombia-based team will assist you in gathering the necessary documentation, translating it to local Colombian Spanish, completing and submitting the application to INVIMA in Colombia.
Medical Device Development
Our clinical group has extensive experience in designing and developing medical technologies. We have the capabilities to offer a complete clinical testing and verification pathway from production ready prototype to acute and chronic animal experiments to first in man and feasibility clinical trials with the highest clinical research standard. We are familiar with the regulatory pathways and its overall impact in bringing a product to market.