Read answers to the frequently asked questions (FAQ) we receive about conducting early-stage, early-feasibility Studies (EFS), and first-in-human (FIH) clinical studies in Colombia

Colombia checks positively on cost, speed, and quality; the main requirements for a medical device company to select a destination for its early-stage/feasibility human studies:

1. Cost: Savings are +30 percent over what the same trial would cost in North America or Western Europe.

2. Speed: The total IRB/EC and MoH (INVIMA) review in Colombia takes 90-120 days.

3. Quality:

   • The World Health Organization ranked Colombia's healthcare system as #22 in a review of 191 countries (read more).

   • The “America Economía" magazine ranked Colombia's hospitals as some of the best in Latin America (read more).

   • The International Living publication ranked Colombia's healthcare system within the top five in the world (read more).

   • Hospitals in Colombia are only allowed to conduct clinical research with pharmaceutical drugs after they have passed a rigorous ICH/GCP certification process.

4. Patient recruitment: Colombia's population is +50 million. About 95 percent of the Colombian population is covered by universal healthcare.

5. R&D tax and financial incentives: Investments in science, technology, and innovation projects get a 100% tax deduction, a 25% tax discount, a 50% future tax credit, and about $10 million in free government money grants. Read more.

1. Obtain study approval from your site's institutional review board (IRB)/ethics committee (EC).

2. Obtain study approval from Colombia's regulatory agency (INVIMA)/Ministry of Health (MoH).

3. Obtain an import permit at Colombia's Ministry of Industry and Commerce (MinCIT) and ship your investigational devices to your site in Colombia.

Read more.

Yes. Clinical Leader has articles here about clinical research in Latin America and in Colombia.

It all started when Dr. Pedro Martinez-Clark —a Harvard-trained interventional cardiologist was a professor at the University of Miami (UM) and in the late 2000s, with Dr. William O'Neill, Dr. Eduardo DeMarchena, and other US physician researchers at UM, started collaborating with a research center in Colombia to do the clinical validation of a new cardiac valve in Colombia being developed by a US Medtech startup. This led Dr. Martinez-Clark to realize that US medical device companies needed help finding cost-effective, ethical and fast investigator and clinical research centers in Latin America, and operationalizing their first-in-human clinical trials in the region.

This led Dr. Martinez-Clark to start a company called Interventional Concepts, Inc. —a Miami-based contract research organization (CRO) dedicated to helping US medical device startups conduct first-in-human clinical trials in Colombia (read more). Later in 2016, the company changed its name to bioaccess™ to reflect its wider focus on clinical research, regulatory, and market access services.

bioaccess™ is now a CRO, regulatory, and market access consulting company that delivers a full spectrum of clinical, regulatory, and market access offerings from bench to commercialization so that medtechs can succeed in Colombia. Our promise is for medtechs that believe that Colombia offers untapped potential to conduct clinical trials or to sell their innovations. We focus on medtechs that want to run a clinical trial or want to have sales growth in Colombia. We promise that by engaging with us, you will cost-effectively get the clinical data you need or will be able to obtain regulatory market clearance in Colombia.

bioaccess™ is the only CRO, regulatory, and market access consulting company vetted and approved as a business service provider to help US medical device companies do business and succeed in Colombia.

Yes, we do. See it here.

We can help you operationalize your planned first-in-human medical device clinical trial in Colombia by providing you with the following services:

• Study design (i.e., protocol writing, production of the study documents including study protocol, investigator's brochure, subject informed consent, case report form) –in partnership with Beacon Launch Partners.

• Feasibility (i.e., investigator/site selection).

• Coordination and attendance of sponsor pre-trial visit in Colombia.

• Coordination and execution of the clinical trial agreement (CTA).

• Gathering, reviewing study documents, and translations to Spanish: 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 the MoH (INVIMA): Includes completing the application, editing of study documents to comply with INVIMA's guidelines, and final assembly (excludes applicable submission fee).

• Submission of the import permit application to Colombia's Ministry of Industry, Commerce, and Tourism (MinCIT).

• Processing of the importation/nationalization of the investigational product.

• Coordination and attendance of site initiation visit and training to site's PI, study coordinator, and relevant staff.

• Project management.

• Study monitoring.

• Reporting (as mandated by INVIMA and the IRB/EC).

INVIMA (Colombia National Food and Drug Surveillance Institute) or “Instituto Nacional de Vigilancia de Medicamentos y Alimentos” in Spanish is a regulatory authority created in 1992 under Colombia's Ministry of Health and Social Protection (MoH or MinSalud). INVIMA is in charge of inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards or procedures, and implementing best practices and providing medical approval for the import and export of products.

The entity within INVIMA that deals with medical device matters is the Directorate for Medical Devices and other Technologies or “Dirección de Dispositivos Médicos y Otras Tecnologías” in Spanish; subordinated directly to the General Directorate. The directorate monitors and controls medical devices, tracks pre- and post-market programs and, among others, suggests technical standards for the manufacturing, marketing, surveillance, and quality assurance of devices.

The Pan American Health Organization/World Health Organization has categorized INVIMA as a Level 4 regional reference health authority. A Level 4 national regulatory authority is one that is competent and efficient in performance of the health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines. Read more.