Interventional Concepts, a leading clinical research organization for innovative pharma, biotech and medtech development-stage companies proposing to conduct clinical trials in Colombia, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit operating in the public interest and committed to transforming the global clinical research environment, have announced a Strategic Alliance, joining Interventional Concepts with current ACRES Allies in their efforts to build ACRES’ shared global clinical research system.
In addition to contributing expertise to ACRES Site Accreditation and Standards Initiative (SASI), Interventional Concepts will work with ACRES and other stakeholders to create ACRES-Colombia, an endeavor that will help link Colombia’s clinical research capacity and stakeholders to the world.
Interventional Concepts, dedicated to life science innovation, has been providing clinical trial regulatory, operational and logistics support since 2010 to development-stage life science startup companies looking for cost-effective clinical research sites in Colombia capable of conducting early-stage human studies. Strategically located close to the US East Coast and sharing the same time zone, Colombia has a free trade agreement with the US and a predictable national regulatory pathway for clinical trials—30 days for medical devices and 60 days for drugs, the fastest in Latin America. It has the healthcare infrastructure and business environment necessary for clinical trials—including the highest ranked hospital in Latin America, over 120 ICH GCP-certified sites and a population close to 50 million with universal healthcare coverage.
Interventional Concepts will work with Colombian institutions, organizations, and companies to set up an ACRES national affiliate in Colombia. ACRES-Colombia will create mechanisms to facilitate appropriate contact between ACRES and Colombian academic institutions, regulatory agencies, and professional associations and to identify opportunities to further develop ACRES-related initiatives. It will promote an all-encompassing system for clinical research in Colombia to ensure the quality, safety, and ethical conduct of trials, including site accreditation, qualification, and certification according to globally-acceptable standards and the communication mechanisms needed to address site-specific needs.
ACRES brings together stakeholders from across the international clinical research eco-system to collaborate on building a much-needed, shared global system for safe, high-performance, clinical research. “Efforts to enhance clinical research capacity and quality in Latin America are very exciting, and Colombia has stepped forward to take a leading role. We are delighted to be working with our colleagues there since a global system only works if it embraces, mobilizes and unifies local resources,” noted Greg Koski, ACRES Co-founder and CEO.
Julio G. Martinez-Clark, Interventional Concepts’ Chief Executive Officer stated, “We look forward to using our experience and expertise to further advance the international expansion of ACRES endeavor to create a collaborative global system for clinical research into Colombia; the first ACRES initiative in Latin America!”
“Bogota welcomes ACRES-Colombia as a catalyzer to transform the local clinical research sector into one that is internationally competitive and aligned with ACRES’ vision to build a global system for excellence in clinical research based on the values of Integrity, inclusiveness, innovation and implementation,” said Diana Gaviria, Executive Director of Connect Bogota.
About ACRES
The Alliance for Clinical Research Excellence and Safety (ACRES) is a non-profit multi-sector alliance working in the public interest. It brings together diverse stakeholders across clinical research, harnesses their expertise to collaboratively build an open, integrated global system based in principles of Accountable Research™ and adapts lessons from industries that successfully implemented principles of systems and safety engineering, such as transportation, communications and information technology. For further information please contact: Mary F. Tobin, PhD, Special Advisor to the President and CEO at mtobin(at)acresglobal(dot)net.
About Interventional Concepts
Interventional Concepts is a contract research organization (CRO) for innovative life sciences startup companies looking to conduct their clinical trials in Colombia. It provides study design and operational support services such as site selection, trial set-up, study project management, regulatory management, logistical management, patient recruitment, techno or pharmacovigilance, medical safety monitoring, adjudication of adverse events, and study monitoring. For further information please contact: Julio G. Martinez-Clark, President & CEO, at jmclark(at)interventionalconcepts(dot)net.
