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Easy Clinical Trials for Medtech & Biotech Startups.

Quality clinical research–done quickly, ethically and at a highly competitive rate in Colombia.

Get US-standard, ethical trials in Colombia; a world leader in volume of clinical research.

Shorten trial start-up. Lower your costs. Recruit more patients, faster. With over 120 government ICH/GCP certified clinical research sites and 30 years of experience, you can run your clinical trials by highly qualified principal investigators.

We have the capacity to run your medtech & biotech clinical trials TODAY.

We'll help you get your import permit approved, import the medical products to be tested, store them in our government-certified warehouse and then manage the trial on your behalf. You'll reach your clinical goals faster, and conduct a completely ethical and accurate trial in the premier destination for early-stage clinical research.

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

The world's most attractive country for clinical testing, with over 115 trials received annually.

  1. With a short, direct flight from Miami, 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 90 days for pharma.

  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
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 medtech & biotech startups looking to conduct their clinical trials in Colombia. We provide operational support services including site selection, trial set-up, study project management, regulatory management, logistical management, patient recruitment, techno or pharma vigilance, medical safety monitoring, adjudication of adverse events, and study monitoring.

We recognized that development stage startups 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.

We recognized that the country of Colombia, with a population of almost 50 million, has over 120 government-GCP-certified clinical research sites. These sites have been conducting trials for almost 30 years, have very little international exposure and are unknown to the medtech & biotech 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 your startup.

Our founder —Dr. Pedro Martinez-Clark, a Harvard-trained interventional cardiologist— envisioned a clinical development and research organization that helped innovative startups reach their clinical development and research goals by partnering them with cost-effective, quality and ethical clinical research sites in Colombia —a hidden gem unknown to the medical technologies industry— and by operationalizing their trials at these sites by providing regulatory, clinical and logistical support.


How we help

Medtech & biotech startups engage our services because they trust us to search, evaluate and select the best site in Colombia where they can conduct their early-stage clinical trial. They trust us to operationalize the logistics and project management of their trials by transferring to us some of their FDA-sponsor-defined obligations. The scope of our services include, 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.


Who trusts us

Clients such as the University of Miami (DirectFlow Medical, NeuroTronik), Mitralign, Roxwood Medical, InterValve, Avinger, CeloNova BioSciences, Syntheon Medical, MitraSpan, Kona Medical, Keraderm, among others, have trusted us with their clinical trials in Colombia. 

We have a true passion for medical innovation.

 

We believe that Colombia represents an untapped opportunity for startup medtech & biotech 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.

Chief Medical Officer

Dr. Martinez-Clark is an interventional cardiologist trained at Harvard University's Beth Israel Deaconess Medical Center, who 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., who is part 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. 


Carlos Valverde, M.D.

Director of Clinical Studies

Dr. Valverde has a 15-year proven track record in clinical research. His experience in medical research include project management and reporting as a consequence of past duties such as research assistant for academic groups at his medical school and for the pharmaceutical industry; he was also a research assistant for the critical care team at Jackson Memorial Hospital in Miami, FL, where he completed his last year of medical school. Dr. Valverde has been the principal investigator for research studies designed by him and financed by a private health insurer. During his studies in Quality Management of Health Services at Pontificia Universidad Javeriana in Bogotá, Colombia, Dr. Valverde learned to apply his research knowledge to the field of health services administration using evidence-based medicine and focused on clinical effectiveness. Dr. Valverde has international certifications that include ECFMG and GCP, and has been the author of several publications. He has also given lectures and has presented posters with the results of his clinical studies.


Osvaldo Martinez-Clark

Vice President of Clinical Development

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 and earned a prior A.A. degree in Computer Networking from Keiser College in Ft. Lauderdale, FL.


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

President & CEO

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. Since late 2012, Mr. Martinez-Clark has led Interventional Concepts, Inc. as its president & CEO.