bioaccess™: Empowering Medtech Advancements through Ethical Clinical Research

In the world of medical technology, the journey from innovation to implementation relies heavily on rigorous clinical research. Serving as a beacon of integrity and innovation in this realm is bioaccess™, a distinguished United States-based contract research organization (CRO) committed to facilitating ethical and efficient clinical trials in Latin America for innovative Medtech companies. Founded in 2010 by Dr. Pedro Martinez-Clark, bioaccess™ has emerged as a pivotal player in bridging the gap between Medtech innovation and clinical research opportunities in the region.

Historical Roots

The origins of bioaccess™ trace back to a collaborative research initiative initiated by Dr. Martinez-Clark and his team of physician-researchers at the University of Miami in 2008. This initiative aimed to evaluate the clinical validation of a novel cardiac valve developed by Mitralign, a Medtech company that is encountering challenges in finding suitable research sites in the United States. Recognizing the untapped potential of Latin America, Dr. Martinez-Clark envisioned bioaccess™ as a solution to unlock clinical research opportunities in the region.

Evolution and Expansion

Initially established as Interventional Concepts in 2010, the organization underwent a transformative journey and rebranded as bioaccess™ in 2016 to reflect an expanded focus on various clinical study services. Over the years, bioaccess™ has evolved and expanded its service offerings and geographical reach, now covering all of Latin America. This expansion has enabled bioaccess™ to effectively cater to the diverse clinical research needs of its Medtech partners, ranging from pilot studies to post-market clinical follow-up (PMCF) studies.

Operational Excellence

bioaccess™ operates as a comprehensive CRO, offering a wide array of consulting services tailored to the unique requirements of Medtech companies. From designing and planning clinical trials to managing projects and coordinating patient recruitment campaigns, bioaccess™’s expertise spans every aspect of the clinical research process. The organization also provides business consulting and management services focused on regulatory compliance and market authorization across Latin American countries, ensuring seamless navigation of regulatory frameworks.

Structural Integrity

At the heart of bioaccess™’s operations lies a robust and transparent structure dedicated to upholding the highest standards of integrity and professionalism. Through strategic collaborations with healthcare and regulatory authorities in both the United States and Latin America, bioaccess™ ensures that all clinical trials are conducted ethically and in compliance with regulatory requirements. This commitment to integrity and transparency underscores bioaccess™’s unwavering dedication to advancing medical technology for the benefit of patients worldwide.

Research Collaborations

The impact of bioaccess™ is evident through its collaborations with leading Medtech companies seeking to innovate and advance patient care. In 2022, Spine Stabilisation Technologies, LLC (SST), a pioneering Texas-based company developing innovative spine disc nucleus replacement technology, selected bioaccess™ as its CRO in Colombia. This partnership aims to expand SST’s clinical research network and generate valuable clinical data to support its groundbreaking treatment.

Conclusion

As the Medtech industry continues to evolve and innovate, bioaccess™ remains steadfast in its commitment to facilitating ethical and efficient clinical research in Latin America. Through its dedication to integrity, professionalism, and innovation, bioaccess™ continues to pave the way for Medtech advancements, ultimately improving patient outcomes and transforming lives across the globe.