Imagine if you could shorten your trial start-up time, save about 50% 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 in Latin America.
Shorten trial start-up. Lower your costs. Recruit more patients, faster. All in Colombia!
- 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.
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.
Great healthcare infrastructure and business environment for clinical trials. Universal healthcare coverage and unparalleled patient pool of all ages.
CenterWatch is talking about Colombia
Who we are
Interventional Concepts is a Miami, FL-based contract research organization (CRO) for life sciences startups looking to conduct their early-stage clinical trials in Colombia (also Poland, India, and Canada). We help clinical trial sponsors with study design, site selection, trial set-up, project management, regulatory submission, product importation and logistics, data management, statistical analysis, study monitoring, and medical writing. Learn more.
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 lengthy due to current FDA regulations and institutional review board processes. This forces startups to look "outside of the US" (OUS) to conduct their foreign clinical trials (FCT) and to look for a country where they can find a competent clinical research site where they can conduct their phase I (drugs) or early-feasibility/first-in-man (medical devices) study. Startups have no well-defined, professional and structured process to identify OUS sites; startups mostly rely on word-of-mouth to identify these sites. Interventional Concepts is the only contract research organization that helps life science startups find an OUS clinical research site in Colombia —now also in Canada, Poland, and India— where they can expeditiously conduct early-stage clinical trials —fast, at lower cost, ethically, and with quality.
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 devices and in 60 days for biotech and pharma. These sites have been conducting trials for almost 30 years, and are unknown to the global life sciences industry. 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 research organization that helped innovative life science startup companies reach their clinical 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 clinical trials (phase I-IV for drugs and early-feasibility, feasibility, pilot, pivotal and post-approval for medical devices). We help with medical device development, study design, site selection, trial set-up, regulatory submission, logistics (import, distribution, disposal, export), project management, study monitoring, statistical analysis, data management, and medical writing. Read more.
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Learn the regulatory pathway to approve your clinical trial faster, save money and recruit patients easier.
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.
Pedro Martinez-Clark, M.D.
Founder & 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. 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.
- Winner of the Life Sciences South Florida's Lifees Award at eMerge Americas 2016.
- 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
Mr. Martinez-Clark is an international business executive with experience in different industries. He holds a B.S. in Electronics Engineering and a Master of Business Administration (MBA). His experience includes positions at Nortel and Alcatel-Lucent. In 2003 he co-founded a real estate investment firm in Orlando, FL. Martinez-Clark has led Interventional Concepts, Inc. since late 2011.
Osvaldo R. Martinez-Clark
Senior Director of Business Development
Mr. Martinez-Clark has over ten years of successful experience in business development, operations management and purchasing. He 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. Mr. Martinez-Clark has double B.A. degrees in International Relations and Political Science from Florida International University.
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.
Michael A. Alvarez
Chief Business Development Officer
Michael A. Alvarez most recently served as vice president for business development for Bell Biosystems, establishing strategic relationships with biotechnology, device and tool companies, and leading the company beta partnership program to engage selected academic and industry labs as early technology adopters. Before this, he was founding director of the MD Anderson Center for Professional Development and Entrepreneurship, facilitating the translation of technologies and expertise into practical application. Prior to this, he founded and directed the Stanford School of Medicine Career Center, establishing external relationships on behalf of the University, advising and developing resources for start-up companies, and designing formal programs to support entrepreneurship and the professional advancement of clinicians and researchers. Throughout more than 20 years, his experience spans both business and academic settings, including coaching and advising at Boston College, management consulting as part of Accenture's NYC practice, founding and directing the UCSF Center for Career & Professional Development, and providing consultation to life science and media companies in the areas of business strategy and organizational design. He is widely sought for input and expert opinion on workforce development, technology commercialization, and medical science training, and has written, reviewed, and published many articles on these topics in key venues. Michael holds bachelor's and master’s degrees from Boston College, a certificate in Intellectual Property Management from the University of Washington, and studied business at IESE in Barcelona, Spain. He is an Emeritus Chair of the BayBio Institute, holds a visiting scholar appointment at UC Berkeley, and actively participates on bioscience boards and committees both regionally and nationally.