The Answer is Colombia

First-In-Human Medical Device Clinical Trials

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


bioaccessla.com

What

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

Our Promise


Our promise is for foreign medical device companies that believe that Latin America offers untapped potential to conduct research and sell their products. We focus on forward-looking medical device 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%-50% cost savings.
  • 50-million population with universal health care.
  • 110+ 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 partner innovative medical device startups with top clinical research sites in Colombia for faster regulatory approval, significant cost savings, and easier patient recruitment.

    Early-Feasibility and First-In-Human Clinical Trial Services

    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

    John B. Simpson, MD

    CEO, Avinger, Inc.

    William Andrews, PhD

    CEO, Sierra Sciences Inc.

    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 based 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.

    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 medical device manufacturers can have long-term success in Colombia.


    CenterWatch Weekly Featured Our Work in Colombia

    Read the article here.



    Company Video

    CLIENTS

    DirectFlow, InterValve, Avinger, Mitralign, MitraSpan, ClarVista Medical, CeloNova BioSciences, Kona Medical, Abiomed, Volcano, Mount Sinai's Center for Personalized Cancer Therapeutics, Keraderm, Libella Gene Therapeutics, Medimaps Group, Omron, Hancock Jaffe Laboratories, EOFlow, ReGelTec, and others.

    Click here for news about our work in Colombia

    Document Requirements

    This is what you need to get your first-in-man trial started in Colombia

    Click here for details

    Team

    Our team is comprised of international senior 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.


    Julio G. Martinez-Clark

    CEO

    Julio has a B.S. degree in electronics engineering and a masters in business administration (MBA). He has been working with US medical device 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.


    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. She has a B.S. degree in computer sciences and graduate studies in business management.


    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 20 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

    Director of Clinical Research

    Cris is our lead clinical research and epidemiology expert. She has a microbiology degree from Javeriana University —one of the top universities in Colombia and in Latin America; she worked for Quintiles —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 also 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.


    Yasmin S. Hernandez

    Senior Regulatory Associate

    For over 20 years, Yasmin has been involved in clinical research in different roles. She has been directly involved in clinical trial IRB/EC and INVIMA regulatory submissions, adverse event reporting, trial start-up and closures, logistics and inventory management of investigational products, etc. From 2006 to 2014, Yasmin worked for Sanofi —one of the top 10 global pharmaceutical companies— as clinical trial regulatory affairs and investigational product coordinator, and from 2014 to 2018 she worked for PRA Health Sciences —one of the top 10 global CROs— as regulatory affairs specialists. Yasmin is based in Bogota, D.C., Colombia.

    TAKEOFF FOR COLOMBIA?

    bioaccessla.com| info@bioaccessla.com