Miami, FL– July 9, 2025 –bioaccess®, the leading first-in-human contract research organization (CRO) in Latin America, proudly announces that our esteemed clinical research partner, Hospital Internacional de Colombia (HIC), has accepted a proposal to obtain the prestigious GCSA (Global Clinical Site Assessment) certification for their clinical research center[1]. This landmark decision will make HIC the first research site in Latin America to achieve this globally recognized certification, reinforcing the region's growing prominence in international clinical research.
A Historic Achievement for Latin American Clinical Research
The GCSA certification represents the world's only internationally recognized global quality standard for clinical research sites, developed through rigorous collaboration with industry leaders from pharmaceutical companies, CROs, regulatory authorities, and healthcare providers across six continents[2]. This evidence-based certification process evaluates seven critical operational areas: patient engagement, feasibility, study start-up & initiation, study management operations & close down, workforce process quality, site business strategy, and governance[3].
HIC's decision to pursue GCSA certification comes at a pivotal moment in the hospital's trajectory. Just last month, HIC became the first hospital in Colombia and South America to join the prestigious Mayo Clinic Care Network, earning recognition as one of the highest-rated medical institutions in Latin America with a Five-Star Global Hospital Rating by Newsweek and Statista[4]. This dual achievement positions HIC as a true leader in both clinical excellence and research innovation.
Strengthening the bioaccess® Partnership
The relationship between bioaccess® and HIC exemplifies the power of strategic collaboration in advancing medical research. As the only first-in-human CRO in Latin America, bioaccess® has partnered with HIC's clinical research department across multiple clinical trials, leveraging the hospital's world-class infrastructure and expertise to deliver fast, cost-effective, and high-quality clinical data to innovative medical device and biopharma companies[5][6].
"HIC's commitment to obtaining GCSA certification demonstrates their dedication to the highest international standards in clinical research," said Julio G. Martinez-Clark, CEO of bioaccess®. "This achievement will not only elevate the quality of research conducted at HIC but also strengthen our collaborative efforts in advancing medical innovation throughout Latin America."
Setting New Standards for Clinical Research Excellence
The GCSA certification process, which will commence by the end of this month, involves a comprehensive 30-120 day assessment journey that includes document review, staff surveys, gap analysis reporting, and potential reassessment[3]. This rigorous evaluation ensures that certified sites meet the robust global best-practice standards ratified by industry leaders, providing reassurance to sponsors, CROs, and ultimately patients that trials are conducted to world-class standards[2].
The certification's significance extends far beyond individual recognition. GCSA certification provides sponsors and CROs with independent quality assurance that research sites can deliver safe, effective, and efficient clinical trials while maintaining the highest ethical standards[2]. For Latin America, HIC's certification will establish a new benchmark for clinical research excellence and attract increased international investment in the region's research capabilities.
Advancing Medical Innovation Through Strategic Partnerships
The timing of HIC's GCSA certification aligns perfectly with the recent launch of IAOCR/GCSA's accredited clinical research certification programs in Latin America. This expansion, supported by partnerships with leading organizations, including bioaccess®, addresses critical regional challenges and empowers Latin American clinical research stakeholders to achieve globally recognized standards of excellence[7].
Latin America's clinical research potential is immense, with cancer trial participation alone projected to grow by 66% by 2040[7]. Through strategic partnerships like the one between bioaccess® and HIC, the region is positioning itself as a clinical research powerhouse capable of delivering high-quality data while offering significant cost advantages and accelerated timelines compared to traditional markets.
Acerca de bioaccess
bioaccess® is a US-based contract research organization (CRO) that bridges the gap between innovative Medtech, Biopharma, and Radiopharma companies and the untapped potential of conducting clinical research studies in Latin America, Eastern Europe, and Australia. Founded in 2010, bioaccess® delivers approximately 40% faster approvals, 50% quicker patient enrollment, and 30% lower costs compared to the US or EU. The company specializes in early feasibility studies and first-in-human trials, helping life sciences companies navigate the complex regulatory landscape while accelerating their path to market.
For more information about bioaccess® and our clinical research services, visit www.bioaccessla.com or contact our team at info@bioaccessla.com.
About Hospital Internacional de Colombia (HIC)
Hospital Internacional de Colombia (HIC), located in Bucaramanga, is part of the renowned Fundación Cardiovascular de Colombia (FCV). Recognized as one of Latin America's premier medical institutions, HIC holds a Five-Star Global Hospital Rating by Newsweek and Statista. As the first hospital in Colombia and South America to join the prestigious Mayo Clinic Care Network, HIC stands at the forefront of medical excellence in the region.
HIC and its Cardiovascular Institute achieved a significant milestone in 2009 by becoming the first hospital in Colombia—and the ninth in Latin America—to earn Joint Commission International (JCI) accreditation, underscoring their commitment to the highest standards of quality and patient safety. The hospital's clinical research center is a leader in conducting high-quality clinical trials across multiple therapeutic areas, partnering with leading CROs like bioaccess® to drive medical innovation and advance healthcare outcomes throughout Latin America.