The Answer is Colombia

First-In-Human Medical Device Clinical Trials

Fast approval. Cost savings. Easier patient recruitment. Quality sites. bioaccessla.com

Who We Are

We are a US-based CRO that helps innovative medical device companies conduct cost-effective first-in-human clinical trials in Colombia.

Our Promise

Our promise is for foreign life science companies that believe that Latin America offers untapped potential to conduct research and sell their products. We focus on forward-looking life science companies that want to run a first-in-human clinical trial and want to have long-term sales growth in the region. We promise that by engaging with us as your CRO, regulatory, or market access consultants, your company will cost-effectively get the clinical data it needs or will be able to increase its sales in Colombia and the rest of Latin America. 

Why Colombia

Colombia is the best country in Latin America for medical device first-in-human clinical trials

  • 30-day MoH approval (after IRB approval).
  • ~30% cost savings.
  • 50-million population with universal health care.
  • 120+ GCP-MoH-certified research sites with over 30 years conducting trials.
  • Quality health care: 50% of the top hospitals in Latin America are located in Colombia. Many of them are Joint Commission-accredited. staffed with US board-certified physicians, and have academic affiliations with US universities.
  • Read more.
  • How We Help

    We partner innovative life science startups with top clinical research sites in Colombia for faster regulatory approval, significant cost savings, and easier patient recruitment.

    Service Capability

    Study design

    Principal Investigator & site selection

    Trial set-up

    IRB and MoH (INVIMA) regulatory submission and approval

    Importation and logistics

    Project/study management

    Patient Recruitment Campaigns

    Study monitoring

    Medical writing/study report

    The World Invests in Colombia


    Colombia, with a population of 50 millions, is the third largest and one of the top performing economies in Latin America. It has a well performing universal healthcare system, and 50% of the best hospitals in the region. It is an OECD member to ensure alignment of its legislation, policies and practices to global first-world standards. It has a free-trade agreement with the US, the EU, and the Pacific Alliance (a future single economic and regulatory market for Mexico, Peru, Chile, and Colombia). It has a fast and efficient regulatory pathway for medical devices —acceptance of USA, EU, Canada, Japan, and Australia free-sale certificates.

    Traditional clinical trials in the U.S. can take years and millions — or even billions — of dollars. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster in Colombia. —Jeff Mathis, Ph.D, President at Libella Gene Therapeutics, LLC


    Testimonials

    William (Bill) Niland, CEO & President, ReGelTec, Inc. | John Simpson, MD, CEO, Avinger, Inc. | William (Bill) Andrews, CEO & President, Sierra Sciences, Inc.


    Client References

    Name

    Company

    Title

    E-mail

    William (Bill) Niland

    ReGelTec, Inc.

    Co-Founder & CEO

    Bniland@regeltec.com

    Dr. William (Bill) Andrews

    Sierra Sciences, LLC

    Founder & CEO

    bandrews@sierrasci.com

    Dr. Marc Glickman

    Hancock Jaffe Laboratories, Inc.

    Senior Vice President and Chief Medical Officer

    mglickman@hancockjaffe.com

    Dr. Jeff Mathis

    Libella Gene Therapeutics, LLC

    President & CEO

    Jeff@libellagt.com

    Shaun ONeill

    PAVmed, Inc.

    Chief Commercial Officer

    smo@pavmed.com


    Obtaining approval for a foreign study is always a challenge. bioaccess™ assistance was invaluable in getting our study approved in Colombia. In addition to having an in-depth knowledge of the regulatory approval process, they also have a deep understanding of the culture. As a result, bioaccess™ has the ability to identify and troubleshoot potential problems before they arise. For companies considering a trial in Colombia, I recommend bioaccess™ without hesitation.” 

    Robert Berman, CEO, Hancock Jaffe Laboratories

    Colombia is Now in Peace

    The Economist named Colombia 'Country of the Year.' Each year, London-based news magazine The Economic selects its “country of the year,” and it named Colombia as its 2016 honoree. “Our pick is Colombia, for making peace in 2016,” wrote The Economist. “This was a colossal achievement.

  • Civilian homicides have decreased 53.3% from 2003 to 2017
  • Kidnappings have decreased 90% from 2003 to 2017
  • The first and only Latin American NATO global partner
  • 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

    CenterWatch Weekly, Miami-based consultancy bringing more U.S. startups’ phase I trials to Colombia, April 6, 2015

    About Us

    bioaccess™: CRO. Regulatory. Commercialization.

    bioaccess™ is a Florida-based CRO and market access consulting company founded in 2010 under its previous name as Interventional Concepts Inc. by Dr. Pedro Martinez-Clark —a Harvard-trained interventional cardiologist, an innovator, founder and advisor to Medtech companies.

    We realized that foreign medical device companies struggle to find a cost-effective early-stage clinical trial site or to gain market share in Colombia —and the rest of Latin America. They are unfamiliar with the region and lack in-house experts who can operationalize a successful clinical research, market access, or regulatory strategy.

    bioaccess™ delivers a full spectrum of clinical research, market access, market entry, and regulatory offerings from bench to commercialization so that foreign life science companies can have long-term success in Colombia.


    CenterWatch Weekly Featured Our Work in Colombia

    Read the article here.



    bioaccess™ has been vetted and selected by the U.S. Department of Commerce to be a preferred Healthcare & Life Sciences Business Service Provider to help U.S. companies succeed in Colombia.

    Read more.


    bioaccess™ Video

    Clinical Trial Experience

    University of Miami, DirectFlow, InterValve, Avinger, Mitralign, MitraSpan, CeloNova BioSciences, Kona Medical, ForSight VISION5, Keraderm, Libella Gene Therapeutics, Hancock Jaffe Laboratories, EOFlow, Establishment Labs, ReGelTec, PAVmed, Flow-FX, BridgeBio/Orfan Biotech, etc.

    Click here for news about our work in Colombia

    Patient Recruitment Campaigns






    We can design, implement, and manage an effective patient recruitment campaign for you in Colombia. The scope of our services include,

  • Social media ads (Facebook & Instagram), Facebook page and landing page.
  • Outreach to referring physicians and searches in patient databases.
  • Patient engagement (calls to patients to schedule visits).
  • See a sample Facebook page here.





    We create a landing page for every patient recruitment campaign to direct the social media ad clicks to it. The landing page informs patients about the clinical trial and provide a click-to-action button to complete a form with a logic map that will helps the patient follow the path most relevant to them while completing the form so that we can pre-qualify them in the trial based on the inclusion and exclusion criteria. 

    See a sample landing page here.



    Our FAQ

    Get answers to the most common questions about how to run a first-in-human clinical trial in Colombia

    Click here for details

    Team

    Our team is comprised of international senior clinical research, regulatory, business development, and sales & marketing professionals specialized in the life science industry with extensive experience in Latin America. They have a proven record of developing and implementing regulatory and business strategies in the region.


    This engagement will be led by,

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

    CEO

    Julio has been working with US life science companies for over 10 years helping them design and implement successful clinical trial, regulatory, and market entry & access winning strategies. Julio is a recognized medical device expert and his insights on the medical device industry have been featured on the industry-leading Med Device Online publication. Julio's latest published article is titled Succeeding In The Latin American Medtech Market: Three Tips, Five Trends. He is the host of the LATAM Medtech Leaders podcast: A weekly conversation with leaders who have succeeded in Latin America. Julio has a B.S. degree in electronics engineering and a masters in business administration (MBA). Read more.

    Hernán Orjuela —a famous Colombian TV presenter— Interviews Julio G. Martinez-Clark, bioaccess.™, CEO. Learn more.


    Listen to LCDR (Select) Jason A. Duprat, MBA, MSA, BSN, CRNA (USNR) interview Julio G. Martinez-Clark on his podcast (The Healthcare Entrepreneur Academy). Learn more.


    Monica C. Mora

    Vice President of Operations

    Monica leads the company's operations, logistics, accounting, human resources and general corporate and project-related administrative matters. Monica has worked for global companies including Alcatel-Lucent and Toshiba and has managed the design and execution of a myriad of first-in-human clinical trials. She has a B.S. degree in computer sciences and graduate studies in business management. Monica is based in Orlando, FL.




    Patricia Durango

    Director of Clinical Operations (Panama)

    Patricia is a regulatory expert in Panama. She was associated at Panamas Ministry of Public Health (MINSA) and led a leadership position at that agency. Patricia has many years of experience in clinical research in Panama, Colombia, Mexico, Honduras, El Salvador, and Guatemala. Patricia contributed to creating the 2019 law No. 84 in Panama that established the current clinical research regulations. She has been a consultant for the Pan American Health Organization, for the Interamerican Bank (BID), and worked for Panama's National Secretary for Science, Technology, and Innovation (SENACYT), and global Pharma companies such as Novartis and Glaxo Smith. Patricia has an M.B.A. in health administration from Universidad del Valle in Colombia and a bachelor's degree in respiratory physiotherapy from Universidad Santiago de Cali in Colombia.


    Ana G. Criado

    Director of Regulatory Affairs

    Ana is our regulatory affairs expert and leader. She worked at Colombia’s regulatory agency —INVIMA— for over five years in different executive and leadership roles. She is a biomedical engineering university professor at Universidad Javeriana and Universidad de los Andes; two of the top private universities in Colombia. Ana is an external regulatory consultant for the Colombian operations of global companies such as General Electric, Omron Healthcare, Mindray, and others. She has a degree in chemical pharmacology; a master's degree in health economics & pharmaeconomics; and certificate degrees in clinical epidemiology, good clinical practices & study monitoring, and pharmacovigilance. Ana is also the founder and CEO of Mahu Pharma; a Colombian company with licenses to cultivate cannabis for medicinal and scientific use and for the manufacturing of raw materials for cannabis-based products. Ana is based in Bogota, D.C., Colombia.


    Cris Venner, EPI, M.R.M.

    Director of Clinical Research

    Cris leads our clinical research projects. She has a microbiology degree from Javeriana University —one of the top universities in Colombia and in Latin America; she worked for Quintiles (now IQVIA™) —the leading CRO in the world; she has a master’s degree on epidemiology from Universidad del Norte —the leading university in Colombia’s Caribbean coast. She was the research director at COFCA—one of the leading ophthalmology research centers in Colombia. Cris has worked in a number of study protocols that have been approved for trials and have successfully managed these trials. Cris is based in Barranquilla, Colombia.




    Takeoff for Colombia?

    bioaccessla.com| info@bioaccessla.com