Partnering with bioaccess®: Your Gateway to Successful Medtech Clinical Trials in LATAM
In the ever-evolving world of medical technology, finding the right partner for clinical trials can mean the difference between success and failure. With the Latin American market emerging as a hotspot for Medtech innovations, choosing a capable collaborator is essential for navigating its unique complexities. Enter bioaccess®, a leader in clinical trial management across LATAM, ready to transform your Medtech journey.
bioaccess® is not just a contract research organization; it embodies a mission dedicated to advancing medical technology through strategic partnerships and innovative research solutions. With a seasoned leadership team, including industry veterans Dr. Pedro Martinez-Clark and Dr. William O'Neill, bioaccess® offers a wealth of expertise and insights into the regional market dynamics. Their commitment to quality and operational excellence positions bioaccess® as the gateway to achieving successful clinical outcomes.
This article delves into the myriad services and advantages of partnering with bioaccess®, exploring their early phase trials, full-service offerings, and deep-rooted commitment to enhancing healthcare outcomes. By prioritizing innovative research and strong partnerships, bioaccess® not only aims to expedite product development, but also to ensure improved health solutions for all. Let’s unlock the potential of your Medtech trials in LATAM together.
What is bioaccess®?
bioaccess® is a leading contract research organization (CRO) based in the United States, dedicated to propelling innovative Medtech companies through successful clinical research in Latin America. As the region's only Medtech-focused CRO, bioaccess® offers unmatched expertise in navigating the complex regulatory landscape and cultural nuances vital for conducting effective clinical trials.
Founded originally in 2010 as Interventional Concept and rebranded in 2016, bioaccess® has become a beacon for early-stage medical device startups. It specializes in first-in-human (FIH), early feasibility (EFS), pilot, pivotal, and post-market clinical follow-up (PMCF) studies. Their services extend across a wide network, including countries such as Mexico, El Salvador, Panama, Dominican Republic, Colombia, Chile, Brazil, Paraguay, and Argentina.
Services Offered:
Regulatory approval assistance
Feasibility and First-in-Human Studies
Cost-effective clinical trial solutions
High-quality clinical data support
By providing rapid, high-quality clinical data, bioaccess® empowers Medtech startups, ensuring they meet the highest standards in clinical development. Whether you're aiming to run a medical device clinical trial or seek greater access to the Latin American market, bioaccess® is your trusted partner.
Mission and Vision
Mission and Vision of bioaccess®
bioaccess® thrives on the mission of bridging innovative Medtech companies with the immense yet underutilized clinical research potential of Latin America. Our commitment to delivering fast, cost-effective, and high-quality clinical data empowers Medtech startups to overcome development hurdles efficiently.
We envision Latin America as a strategic hub for conducting early feasibility and first-in-human (FIH) studies. Our leadership team is dedicated to expanding our service capabilities across the continent, ensuring that we meet the unique clinical research needs of our Medtech associates.
By offering personalized care and advocacy, bioaccess® empowers Medtech companies to achieve optimal wellness and successful clinical trial outcomes.
Key Aspects of Our Mission:
Bridging Medtech innovation with Latin America's potential.
Delivering cost-effective and high-quality clinical data.
Supporting early feasibility and FIH research endeavors.
Personalized care and advocacy for successful trials.
Vision: To establish Latin America as a leading destination for pivotal clinical development, thereby transforming the landscape for Medtech startups seeking regulatory approval and success.
Leadership Team
At bioaccess®, our leadership team is composed of seasoned professionals with over 15 years of experience in the Medtech industry, ensuring our ability to provide specialized clinical research services. Each team member plays a critical role in fulfilling our mission of making Latin America a premier destination for clinical research, ultimately facilitating the success of Medtech startups in achieving regulatory approval and market success.
Dr. Pedro Martinez-Clark
Dr. Pedro Martinez-Clark is a distinguished physician renowned for his exceptional contributions to medical care and innovation. Based in Miami, Florida, Dr. Martinez-Clark's journey in medicine began at the esteemed Universidad del Norte in Barranquilla, Colombia, where he earned his medical degree.
His pursuit of excellence led him to Case Western Reserve University in Ohio for post-graduate training in Internal Medicine. Further honing his expertise, he secured a highly competitive Clinical Fellowship in Cardiovascular Disease at Beth Israel Deaconess Medical Center, affiliated with Harvard Medical School.
During his tenure at Harvard, Dr. Martinez-Clark participated in groundbreaking clinical trials and delved into numerous research projects. It was here that his passion for medical device innovation began to flourish.
Highlights of Dr. Martinez-Clark’s Career:
Medical Degree: Universidad del Norte, Colombia
Post-graduate Training: Case Western Reserve University, Ohio
Clinical Fellowship: Beth Israel Deaconess Medical Center, Harvard Medical School
Dr. Martinez-Clark's commitment to advancing healthcare through clinical trials and medical device innovation continues to make a significant impact, cementing his reputation as a pioneer in the field.
Dr. William O'Neill
Dr. William O'Neill stands as a beacon in the field of interventional cardiology, revolutionizing practices with his pioneering work in mechanical rotational atherectomy. This innovative technique utilizes a catheter equipped with a rotating, diamond-tipped burr to effectively remove arterial plaque, offering new hope to countless patients.
He is a founding member of the American Board of Internal Medicine Interventional Cardiology Board, playing a crucial role in shaping the certification process for interventional cardiologists. His scholarly contributions are monumental, with over 300 peer-reviewed articles and abstracts, numerous book chapters, and editing one of the first textbooks in interventional cardiology.
Dr. O'Neill's excellence has been celebrated with numerous accolades, including recognition in Best Doctors in America and America's Top Doctors. In 2002, he received the prestigious TCT Lifetime Achievement Award, underscoring his lasting impact on the field.
Achievements
Pioneering Techniques: Developed mechanical rotational atherectomy.
Leadership: Founding member of Interventional Cardiology Board.
Publications: 300+ Articles, Numerous book chapters.
Awards: TCT Lifetime Achievement Award, 2002.
Dr. O'Neill's work continues to inspire current and future generations of cardiologists.
Advisory Board
The advisory board stands as a pillar of expertise and innovation, boasting remarkable talent from the healthcare sector. At the forefront is Ron Zelhof, a seasoned leader with a distinguished 30-year career marked by transformative contributions to high-growth healthcare services companies. His tenure at private-equity-backed giants such as Surgery Partners and AirSculpt Technologies showcases his ability to propel organizations to new heights.
Zelhof brings unparalleled expertise in executive roles and a keen ability to foster growth in portfolio companies, honed over a dynamic 15-year partnership with leading private equity firms. In his most recent role, he excelled as president and chief operations officer at AirSculpt Technologies, providing strategic vision and operational excellence.
Key Contributions of Ron Zelhof:
Leadership in healthcare service expansion
Success in private-equity environments
Driving growth in portfolio companies
Innovative approaches in operational strategies
Alongside Zelhof, the advisory board features a cadre of experts armed with significant backgrounds in healthcare innovation and operational excellence. This blend of knowledge and experience serves as a critical asset, driving progress and ensuring strategic guidance for emerging challenges in the healthcare industry.
Services Offered by bioaccess®
bioaccess® is at the forefront of facilitating medical device clinical trials, providing a broad spectrum of services specifically designed to meet the needs of Medtech startups aiming to break into the market. Specializing in first-in-human (FIH), early feasibility (EFS), pilot, pivotal, and post-market clinical follow-up (PMCF) studies, bioaccess® leverages its expertise and strategic location in Latin America to offer unmatched support throughout the clinical development lifecycle.
Early Phase Trials
bioaccess® excels in delivering early phase trial services, focusing on FIH and EFS clinical studies. These early trials are crucial for Medtech startups, as they require meticulous planning and execution to ensure devices are safe and effective. Notably, bioaccess® offers expedited evaluation timelines, facilitating a swift 30-90 day process through the national Ministry of Health in various Latin American countries. This accelerated timeline helps medtech companies initiate their studies quickly, gaining a competitive edge.
With operations expanded across the entirety of Latin America, bioaccess® provides comprehensive early phase clinical research services. Its track record includes over 100 successful clinical trials, a testament to its ability to effectively manage the complexities of early-stage studies. The clinical research team at bioaccess® brings over 15 years of specialized experience, ensuring that each trial is executed with precision and attention to detail.
Key Features:
FIH and EFS specialization
30-90 day MoH evaluation timeline
Operations across all of Latin America
100+ successful early phase clinical trials
15+ years of clinical research expertise
Full-Service CRO Offerings
As a full-service Contract Research Organization (CRO), bioaccess® is committed to providing innovative and cost-effective clinical research solutions tailored to Medtech startups. By supporting efforts for faster regulatory approval and efficient trial processes, bioaccess® empowers companies to focus on innovation and market expansion.
The organization offers a comprehensive suite of services covering the entire spectrum of clinical studies, from early feasibility and pivotal studies to post-market clinical follow-ups. By expanding its operations beyond Colombia to all of Latin America, bioaccess® ensures accessible, high-quality clinical research support wherever it's needed.
bioaccess® streamlines the clinical trial process through services like clinical research site activation, subject recruitment, and meticulous trial data management. With over 100 Medtech firms placing their trust in bioaccess®, the CRO has established a reputation as a vital partner, adept at navigating the intricate regulatory landscapes across multiple countries.
Comprehensive CRO Services Include:
Early feasibility and pivotal studies
Post-market clinical follow-ups
Clinical research site activation
Subject recruitment and data management
Trusted by over 100 Medtech companies
By offering these robust services, bioaccess® is dedicated to accelerating the path from concept to commercialization for medtech innovators, ensuring reliable, repeatable, and regulatory-compliant results.
Operational Excellence
Operational excellence in the healthcare sector is not just a goal—it's a necessity for transforming Medtech startups into successful ventures. At the forefront of this transformation is Ron Zelholf, whose leadership at AirSculpt Technologies is a shining example of turning a founder-led startup into a successful enterprise, facilitated by a strategic initial public offering (IPO). Leading the operational charge at Surgery Partners, Ron was instrumental in optimizing processes across Florida's ambulatory surgical centers, proving the power of effective operational management.
Similarly, bioaccess® embodies this excellence through its experienced clinical research team in Latin America. With over 20 years of expertise, bioaccess® excels at regulatory dossier processing and study approvals. Julio G. Martinez-Clark, the CEO, has supported over 100 Medtech companies, helping them design and operationalize winning clinical trial strategies. This strategic approach highlights the importance of structured operational frameworks to conquer market access challenges in Latin America.
Clinical Site Network
Innovative Medtech startups seeking to advance their clinical research should look no further than bioaccess®—a matchmaker connecting these startups with top-ranked clinical research sites across Latin America. This connection ensures efficient trial data management and smooth regulatory approval processes. The team has a track record of processing and approving hundreds of regulatory dossiers for medical device clinical trials, demonstrating their robust expertise in the field.
By identifying several Latin American countries as untapped for first-in-human clinical research, Julio G. Martinez-Clark positions bioaccess® as a visionary leader in the CRO landscape.
Local Presence
Rooted in Colombia, bioaccess® has strategically expanded its operations across Latin America, becoming a leading contract research organization (CRO) in the region. Specializing in first-in-human (FIH), early feasibility (EFS), pilot, pivotal, and post-market clinical follow-up (PMCF) studies, the company tailors its services to meet the unique needs of Medtech startups.
Julio Martinez-Clark champions Latin America as an untapped destination for Medtech clinical research, offering U.S.-based startups a cost-effective and high-quality alternative. By facilitating the regulatory approval process, bioaccess® ensures efficient trial management and execution, accelerating clinical study results in the Latin American market. The emphasis is on providing expert, cost-effective medical device CRO services that drive growth and innovation for Medtech startups.
Clinical Site Network
When navigating the complex landscape of medical device clinical trials, choosing the right Clinical Site Network is crucial for success. bioaccess® stands out as a leading partner, offering unparalleled support to Medtech startups. With a strong foothold in Latin America, bioaccess® connects innovators with top-ranked clinical research sites, ensuring efficient data management and smooth regulatory approvals.
bioaccess® has a proven track record, having processed and approved hundreds of regulatory dossiers in the region. Under the leadership of CEO Julio G. Martinez-Clark, they identify untapped markets in Latin America as prime locations for First-in-Human (FIH) trials, offering unique opportunities for groundbreaking Medtech advancements.
The involvement of bioaccess® regulatory experts in supporting submissions ensures a streamlined process, making bioaccess® an invaluable partner in accelerating clinical research. Their approach focuses on expediting site activation and patient recruitment, crucial stages that often hinder timely completion.
Whether you're an established company or an early-stage startup, leveraging the expertise and network of bioaccess® can significantly enhance your clinical development journey, positioning you for success in reaching pivotal study milestones. Unlock the potential of Latin America's emerging market with bioaccess®—your gateway to successful medical device trials.
Local Presence
bioaccess® has firmly established itself as a leading contract research organization (CRO) in Latin America, dedicated to advancing Medtech clinical research. bioaccess® boasts a robust Latin America regional presence, catering specifically to Medtech startups' needs.
Here's how bioaccess® stands a class apart:
Comprehensive Study Support: Specializes in first-in-human (FIH), early feasibility (EFS), pilot, pivotal, and post-market clinical follow-up (PMCF) studies.
Expert Regulatory Guidance: Works closely with startups, easing the pathway to regulatory approval.
Efficient Trial Management: Ensures timely, effective execution of clinical trials.
Cost-Effective Services: Provides high-quality CRO services while maintaining cost efficiency.
Julio Martinez-Clark, CEO of bioaccess®, champions Latin America as a hidden gem for Medtech clinical research. He highlights the region's potential to accelerate clinical study results, particularly for U.S.-based startups.
By leveraging bioaccess®'s local expertise, Medtech startups can navigate the complexities of clinical development more efficiently and cost-effectively in Latin America.
Therapeutic Areas of Focus
When it comes to medical device clinical trials, bioaccess® stands out with its exceptional expertise across a wide range of therapeutic areas, ensuring comprehensive support for Medtech companies in Latin America. Our focus spans several crucial fields, ensuring that innovative solutions are brought to life and patient care is enhanced.
Therapeutic Areas of Focus:
Neurology: Tackling complex brain and nerve disorders with cutting-edge technologies.
Ophthalmology: Advancing eye care through novel devices and treatments.
Odontology: Revolutionizing dental care with innovative oral health solutions.
Cardiovascular: Covering cardiac, veins, and peripheral vascular interventions for better heart health.
Orthopedics: Enhancing mobility and recovery with state-of-the-art orthopedic devices.
General Surgery: Facilitating precise surgical solutions for various conditions.
Robotic Surgery: Leading the charge in minimally invasive and highly accurate surgical technologies.
Oncology: Focusing on cancer treatment with pioneering devices and approaches.
bioaccess® not only supports Early-Feasibility, First-In-Human, and Post-Market Clinical Follow-Up Studies but also ensures smooth regulatory approvals crucial for trial success. By bridging Medtech startups with clinical sites in Latin America, bioaccess® is dedicated to driving clinical development and securing timely regulatory approval, vital for every emerging medical device.
Innovative Research Solutions
In the competitive world of Medtech, securing regulatory approval and executing clinical trials are crucial for success. For over 15 years, bioaccess® has been a leader in providing innovative research solutions tailored for early feasibility and first-in-human studies across Latin America.
Key Advantages:
Expertise: With a profound understanding of regulatory dossier processing, bioaccess® has facilitated successful clinical trials in Latin America, a region seen as a burgeoning opportunity for Medtech startups.
Comprehensive Support: The organization aids over 100 Medtech companies by designing and implementing effective clinical trial and market access strategies since 2010.
Strategic Connections: Partnering with top-ranked clinical research sites, bioaccess® ensures efficient patient recruitment and seamless navigation through regulatory landscapes.
Under the leadership of CEO Julio G. Martinez-Clark, bioaccess® offers Medtech startups unparalleled opportunities to carry out pivotal studies with dependable and timely results. Latin America's untapped potential as a hub for early-stage clinical research is within reach, paving the way for your medical innovations. Choose bioaccess® for a strategic partner in clinical development and market success in Latin America.
Partnerships to Advance Medical Innovation
At bioaccess®, we are dedicated to advancing medical innovation by serving as the essential bridge between Medtech startups and premier clinical research sites in Latin America. Our core mission is to enable cost-effective, high-quality medical device clinical research, positioning startups for successful regulatory approval and investment opportunities. By collaborating with us, companies gain access to comprehensive clinical development services that include early feasibility studies and pivotal studies tailored for Medical Device Clinical Trials.
Our accomplished Chief Operations Officer, Monica C. Mora, has spearheaded the implementation of effective regulatory and clinical strategies since 2013, ensuring that our clients navigate the complex healthcare landscape with ease and confidence. Moreover, our advisory board consists of industry veterans who bring diverse expertise in entrepreneurship and healthcare innovation, further strengthening the support available to our clients.
Benefits of Partnering with bioaccess®:
Connection to top-ranked clinical research sites
Reliable and timely trial outcomes
Enhanced pathways for regulatory approval
Strategic partnerships for funding and development
Join us at bioaccess® and unlock the potential for your Medtech startup to thrive in one of the world's most dynamic regions for clinical studies. Together, we can turn groundbreaking medical innovations into reality.
Enhancing Healthcare Outcomes
Enhancing Healthcare Outcomes in Latin America
The healthcare innovation landscape in Latin America is undergoing a transformative shift, thanks to key figures like Dr. Martinez-Clark, Julio Martinez-Clark, and Monica C. Mora. Their efforts are pivotal in improving healthcare outcomes across the region through strategic collaborations and expert-led clinical trials.
Dr. Martinez-Clark is a catalyst for healthcare innovation in South Florida, working with both public and private entities to drive medical care advancements. Julio Martinez-Clark's expertise in Medtech clinical trial strategies underscores their importance in advancing medical knowledge and improving patient outcomes. Meanwhile, Monica C. Mora expertly operationalizes clinical trial strategies for medtech companies, paving the way for groundbreaking healthcare solutions throughout Latin America.
These trials are crucial for medtech startups and established companies alike, offering insights for regulatory approval and the development of first-in-human (FIH) studies.
Key Contributions:
Dr. Martinez-Clark: Facilitates public-private partnerships in healthcare innovation.
Julio G. Martinez-Clark: Advances medical knowledge through expert-led trials.
Monica C. Mora: Strategies for clinical trials across Latin America.
The combined efforts of these experts highlight the critical role contract research organizations (CROs) play in Latin America's healthcare evolution, setting the stage for future breakthroughs and healthier communities.
Commitment to Quality Results
bioaccess® is a trusted ally for Medtech companies aiming to achieve excellence in clinical research within Latin America. Our commitment to delivering fast, cost-effective, and high-quality clinical data sets us apart in the clinical development landscape.
Medtech startups and established enterprises alike can benefit from our expert navigation of the regulatory approval processes. With our in-depth knowledge and experience, we ensure that your clinical studies meet stringent standards, paving the way for successful outcomes. Whether it's an early feasibility or pivotal study, we understand the nuances involved in Latin America’s regulatory environment.
Key Commitments:
Speed: Accelerating timelines for clinical trials without compromising on quality.
Cost-effectiveness: Delivering value-driven solutions to optimize research budgets.
Quality: Ensuring robust data and ethical standards across all clinical studies.
Trust bioaccess® for your clinical trials, and experience the seamless integration of quality, speed, and cost-effectiveness, ensuring your medical devices reach the market efficiently and successfully.
Future Directions for bioaccess®
As the landscape of clinical trials continually evolves, bioaccess® is strategically poised to lead Medtech startups through the intricacies of the process with unmatched expertise and localized knowledge in Latin America. Future directions for bioaccess® focus on enhancing their capabilities to assist medical device companies in achieving swift regulatory approval and overcoming recruitment challenges.
Key Future Directions:
Expansion of Services: bioaccess® plans to broaden its suite of services in more Latin American countries to include comprehensive support for Early-Feasibility Studies and First-In-Human (FIH) trials, ensuring that startups can rapidly move from early-stage development to pivotal studies.
Strengthened Local Partnerships: By forging stronger ties with local health systems and regulatory bodies, bioaccess® aims to streamline the clinical trial process further, cutting down on bureaucratic delays.
Innovative Trial Designs: Emphasizing adaptive and hybrid trial designs will facilitate more flexible and efficient clinical studies, optimizing resource allocation and timelines.
Enhanced Data Solutions: Offering cutting-edge data management and analytics tools, bioaccess® will empower Medtech companies to make informed decisions, accelerating progress toward product launch.
Through these initiatives, bioaccess® is committed to solidifying its position as a premier Contract Research Organization (CRO) in Latin America, driving success for Medtech startups with visionary precision.
Conclusion
Partnering with bioaccess® offers Medtech startups an unparalleled opportunity to navigate the complex landscape of clinical trials in Latin America. With their deep regulatory expertise, local market knowledge, and robust, tailored services, bioaccess® is a reliable ally in expediting the pathway to market for innovative medical devices. As the organization continues to evolve and expand its offerings, it remains dedicated to overcoming challenges and embracing new opportunities in the field.
In a region known for its diverse needs and growing healthcare demands, bioaccess® is well-positioned to guide companies through the intricacies of clinical studies, ensuring that groundbreaking solutions are delivered to patients promptly and efficiently. Embrace the future of Medtech with bioaccess®—your trusted partner for successful clinical trials and a brighter healthcare landscape in Latin America. Ready to elevate your medical device clinical trials in Latin America? Contact bioaccess® today to discover how our expertise can support your research initiatives!
