full_d_e266ac91-56b4-43e7-8743-a9c805ef9522-interventional_concepts_clinical_trials.jpg

Did you know that Colombia's national regulatory agency can approve a medical device trial in 30 days and a drug trial in 60 days?

Did you know that Colombia has over 120 government ICH/GCP certified clinical research sites with 30 years of experience where you could run your clinical trials by highly qualified principal investigators? 

Did you know that Colombia offers fantastic cost savings over 30% of what it will cost to run a trial in the US or Europe?

Imagine if you could shorten your trial start-up time, save over 30% on your trial costs, and access a 50-million-patient population with universal health coverage.

You don't have to imagine it. In fact, we have created a way to easily bring Colombia's excellent clinical research capacity to you so that you run your clinical trial TODAY. Colombia has the fastest regulatory approval time is the most clinical trial-friendly country in Latin America. 


Trusted by


I can only say good things about our experience in Colombia.
— John B. Simpson, MD. CEO, Avinger, Inc.

Shorten trial start-up. Lower your costs. Recruit more patients, faster. All in Colombia!

  1. With a short, direct flight from Miami, FL, you'll find that Colombia is well worth the quick journey, compared to wait times and hurdles for other countries with the same exact standards
  2. Get fast product importation with a free trade agreement with the US. And a fast and predictable regulatory pathway —about 30 days for medical devices and 60 days for pharma or biotech.

  3. Great healthcare infrastructure and business environment for clinical trials. Universal healthcare coverage and unparalleled patient pool of all ages.

CenterWatch is talking about Colombia

 
The combination of good healthcare (95% of Colombian citizens have health insurance), an already strong clinical trial industry, stringent regulations issued in 2008 that requires sites to be certified by INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) and a relatively quick and predictable approval process for launching a trial has made it a desirable clinical trial destination.
— Ronald Rosenberg, CenterWatch Weekly, April 6, 2015
 
 
 
 

 
 
 
 
 
The government of Colombia, in collaboration with the clinical development firm Interventional Concepts, is actively seeking to promote Colombia as a destination for early-stage clinical trials. Between 1995 and 2013, 738 clinical trials were conducted in the country. Although approximately 90 percent of those studies were in the pharmaceutical space, a growing number are being performed in the medical technology field for companies such as Avinger, Kona Medical, and InterValve.
— Stanford University, Biodesign

When it comes to launching early clinical trials for medical devices, the three leading Latin American countries are Colombia, Paraguay and Chile...Colombia also is relatively close to the East Coast with short flights, has a stable government and is the only country trying to attract startups and small companies for phase I. It is harder and more costly to do early stage trials in the U.S., and Colombia hospitals and some doctors have close relationships with the University of Miami Medical School, a teaching hospital.
— Jonathan Rourke, CEO & co-founder, Mitraspan, Inc., CenterWatch Weekly, April 6, 2015

Who we are

We are a contract research organization (CRO) for life sciences startups looking to conduct their clinical trials in Colombia. We provide study design and operational support services such as site selection, trial set-up, study project management, regulatory management, logistical management, patient recruitment, techno or pharmacovigilance, medical safety monitoring, adjudication of adverse events, and study monitoring.

Development stage life science (medtech, biotech and biopharma) startup companies struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality and ethical clinical research at a very competitive cost. The regulatory process of conducting a first-in-human or any type of early-stage clinical research trial in the US is very lengthily due to current FDA regulations and institutional review board processes. This forces startups to look "outside of the US" (OUS) to find a competent clinical research site where they can conduct their feasibility or first-in-man study. Startups have no well-defined, professional and structured process to identify OUS sites; startups mostly rely on word-of-mouth to identify OUS sites. Interventional Concepts is the only CRO company in the world that helps life science startups find an OUS clinical research site where they can quickly, safely and ethically conduct their early-stage trials. 

We recognized that the country of Colombia, with a population of almost 50 million, has over 120 government ICH/GCP-certified clinical research sites and has the fastest regulatory process in Latin America —studies can be approved by the national regulatory agency in 30 days for medical device and in 60 days for drugs. These sites have been conducting trials for almost 30 years, have very little international exposure and are unknown to the life sciences industry around the world. These are highly qualified sites that receive about 100 annual trials sponsored mainly by the local Colombian subsidiaries of multinational pharmaceutical companies. These sites are staffed by experienced and highly trained personnel and can be made available to any life science startup. 

Our founder —Dr. Pedro Martinez-Clark, a Harvard-trained interventional cardiologist— was inspired at the University of Miami by his product development work alongside the world-renowned Dr. William O'Neill. He and Dr. O'Neill —a member of our advisory board— envisioned a clinical development and research organization that helped innovative startups reach their goals by partnering them with cost-effective, quality and ethical clinical research sites in Colombia —a hidden gem unknown to the life sciences innovation industry— and by operationalizing their trials at these sites by providing regulatory, clinical and logistical support.


How we help

Our clients trust us to search, evaluate and select the best site in Colombia where they can conduct their early-stage clinical trials. We help with medical device development, study & protocol design, site selection, trial set-up, regulatory submission, study project management, study monitoring, safety monitoring, logistics (import, distribution, disposal, export), data management, and patient recruitment. Read more


Free Colombia Clinical Trial Guide

Download our free guide to conduct a clinical trial in Colombia. Learn about the regulatory pathway to get your trial approved now!

We have a true passion for medical innovation.

 

We believe that Colombia represents an untapped opportunity for life science startup companies to conduct cost-effective, quality and ethical early-stage clinical trials —with the same quality standards that they would find in the U.S. or Europe.

 

Leadership Team


Pedro Martinez-Clark, M.D.

Pedro Martinez-Clark, MD

Chief Medical Officer

Dr. Martinez-Clark is an interventional cardiologist trained at Harvard University's Beth Israel Deaconess Medical Center. He later became assistant professor at the Miller School of Medicine at the University of Miami where he worked side-by-side with the internationally renowned William O'Neill, M.D. —a member of our advisory board. Dr. Martinez-Clark was part of the University of Miami's International Medicine Institute where he acquired extensive experience in international clinical trials and program development. Dr. Martinez-Clark currently serves as Chief Medical Officer for Interventional Concepts, Inc. With board certifications in internal medicine, cardiovascular medicine and interventional cardiology Dr. Martinez-Clark has developed an international cardiovascular practice in Miami, FL and has positioned himself as one of the top cardiologist in the region.  

  • Pioneer in percutaneous aortic valve replacement in South Florida.
  • Co-developed several cardiovascular technologies and procedures.
  • Winner of the “best research award” at the 2014 SCAI meeting.
  • Past medical director for Syntheon, LLC —a medical device firm in South Florida.
  • Co-founder of Miami MedTech, the first Miami-based healthcare incubator for medical technologies.
  • Founder and chief medical officer of Interventional Concepts, Inc., a contract research organization for early-stage life science startups.
  • International speaker, author of numerous juried and indexed journal publications, and co-author of the Hurst medical textbook chapter on systems of care for primary angioplasty. 
  • Read more

Julio G. Martinez-Clark, M.B.A.

President & CEO

Julio G. Martinez-Clark

Mr. Martinez-Clark is an accomplished international business executive with experience in different industries. Mr. Martinez-Clark holds a Bachelor of Science in Electronics Engineering (BSEE) and a Master of Business Administration (MBA) and is fluent in Spanish, English, and Portuguese. He has extensive business experience in the US, Europe and Latin America & the Caribbean. His professional experience includes positions at Nortel and Alcatel-Lucent. At Alcatel-Lucent, he was the technical leader of the implementation of Spain's Telefonica’s IP network in Colombia; later, as an offer manager, he established executive level relationships with end-customers, distributors, and regional and global partners such as IBM and Oracle. He had the unique opportunity to re-create Alcatel-Lucent Business Partner program in Latin America from a 1-page agreement to a world-class channel program. He gained experience driving business projects and programs, measuring business performance and trends, and communicating cross-functionally. In 2003, Mr. Martinez-Clark was the co-founder and president of a real estate investment firm in Orlando, FL; here, he gained invaluable business, investment, legal and financial skills. Martinez-Clark has led Interventional Concepts, Inc. as its president & CEO since late 2012.


Osvaldo R. Martinez-Clark

Senior Director of Business Development

Osvaldo R. Martinez-Clark

Mr. Martinez-Clark is a highly accomplished business executive and management professional with over ten years of successful experience in business development, operations management and purchasing. Mr. Martinez-Clark is well versed in helping companies achieve their clinical development and research goals by expediting their required clinical trials of new products and devices prior to their FDA approval and/or CE Marking and has acquired exceptional negotiation skills in dealing with a broad spectrum of businesses in a variety of multicultural and competitive business environments. Mr. Martinez-Clark has demonstrated a career-long commitment to cultivating and sustaining long-term, mutually beneficial relationships with key clients and vendors based on trust and integrity; he was born and raised in Colombia and came to the U.S. after completing his high school education and  earned his two B.A. degrees in International Relations and Political Science from Florida International University.


Carol A. Pregonero, PhD

Carol A. Pregonero, Ph D.

Director of Clinical Development & Regulatory Affairs

Dr. Pregonero earned her PhD in biomedical engineering from Mississippi State University in 2009 and her B. Sc in biomedical engineering from Escuela de Ingeniería de Antioquia (Medellín, Colombia) in 2004. She has over 5 years of experience in the life sciences industry and has participated in various roles in multi multicentric clinical trials in Europe and Colombia. Dr. Pregonero is a results-driven individual always willing to take new challenges and responsibilities. She successfully initiated Theradex —a leading oncology-focused CRO— operation in Spain by initiating the company's first phase I/II clinical trial in the country. She has expertise in setup and management of the complete cycle for phase I/II/III trials (in different therapeutic areas with special emphasis in oncology) across Europe and Colombia. In 2014 she was appointed project manager for a phase I clinical trial with a gene therapy medicinal product (GTMP) for cervical intraepithelial neoplasia (CIN). In early 2015 she became the clinical operations manager for a CCBR —one of the world’s largest organizations dedicated to conducting clinical trials— site in Medellín, Colombia.


Jorge Franceschi, MSH, RDN, CCRC

Business Development & Project Manager

Mr. Franceschi has been in the research industry and involved in the development of pharmaceuticals, devices, vaccines, and biotechnology for the past 15 years. During that time, he has had roles in operations, business development, finances, and market intelligence. In pharma, he has experience with Phase I, Phase II, Phase III, & Phase IV research including PK/PD studies. This has also included pharmacogenetics research and he has worked with both pediatric and adult research subjects. He has been involved in 510k submission research, novel vaccine research, and AMP vaccine research.