Raising the Bar for Clinical Research Quality in Latin America Unidad de Estudios Clínicos del Hospital Internacional de Colombia – FCV Achieves GCSA Site Certification
Clinical research quality standards in Latin America have reached an important new milestone. The International Accrediting Organization for Clinical Research (IAOCR) is proud to announce that Hospital Internacional de Colombia – FCV has become the first clinical research site in Colombia to achieve GCSA Site Certification.
This landmark achievement represents a major step forward for the region and firmly positions HIC – FCV among a global community of leading clinical tria sites recognized for excellence, quality, and operational capability.
A First for Colombia - and a Significant Milestone for the Region
Achieving GCSA Site Certification places Hospital Internacional de Colombia – FCV at the forefront of clinical research excellence in Colombia and across Latin America. As the FIRST site in the country to meet this internationally benchmarked quality standard, it is setting a new reference point for clinical research quality, governance, and business operational excellence across the region and globally.
The certification reflects not only alignment with sponsor/CRO defined quality standards across seven critical business operational areas, but also provides a demonstrable commitment to delivering consistently high-quality clinical trials that meet the expectations of participants, sponsors, and CRO partners worldwide.
Leaders in Clinical and Research Excellence
The Hospital Internacional de Colombia – FCV is internationally respected for its advanced infrastructure, commitment to innovation, and dedication to improving patient outcomes. Its membership in the Mayo Clinic Care Network further reinforces its standing as a leader in clinical care and clinical research excellence across Latin America.
By achieving GCSA Site Certification, HIC–FCV has reinforced its strategic vision to embed quality at every level of its research operations and to deliver world-class research experiences for both participants and sponsor/CRO partners. This achievement also reflects its broader ambition to expand access to high-quality clinical research across Colombia, the wider Latin American region and globally.
“For the Clinical Research Unit of the Hospital Internacional de Colombia – FCV, advancing through the GCSA certification process marked an important step in our commitment to quality, ethics, and excellence in clinical research. We have always believed that every study is an opportunity to change lives, which is why we worked with rigor, care, and a strong commitment to continuous improvement, always placing the well-being of our participants at the centre of everything we did.
More than a recognition, the certification process gave us the opportunity to take a critical look at how we worked, strengthen our culture of quality, and align our practices with international standards. The assessment was demanding, yet highly valuable, helping us strengthen governance, improve our processes, and continue to grow as a clinical research unit.
Through this achievement, we hope that sponsors from around the world will see in Colombia and in our team a reliable, committed, and well-prepared partner for conducting clinical trials with excellence. This recognition reflects the dedication of our multidisciplinary team and the trust placed in us by our investigators, sponsors, CROs, and strategic partners. To grow in quality is to grow in impact, and our focus has always been on people,” says Dr. Diego Gómez Abreo, Medical Director of the Clinical Studies Unit at Hospital Internacional de Colombia – FCV.
What Is GCSA Site Certification?
The GCSA Quality Standard and Certification was developed in direct response to industry demand from sponsors and CROs for a quality standard that determined operational excellence in clinical trial sites from a business and partner perspective. It was built to address key industry challenges and facilitate synergistic working between sites and sponsors/CROs to enable better participant (and client) experiences.
GCSA was developed by IAOCR over a four-year period in close consultation with a ‘Global Advisory Board’ made up of key stakeholders from the global clinical research industry.
The structured and supportive GCSA Certification Journey guides sites through a comprehensive review, assessment and gap analysis process, leading to a tailored action plan that ensures the integration of global best-practice business processes and procedures across the end-to-end clinical trials pathway. The Standard evaluates seven core business operational areas identified by Sponsors and CROs as critical to the successful delivery of high-quality clinical trials – these include:
Sites that achieve the GCSA Quality Standard are awarded the GCSA Certification Mark, a clear sign of quality denoting them as ‘Trusted Global Clinical Research Partners’ and providing them with clear differentiation in an increasingly competitive clinical research marketplace.
A Commitment to Global Standards
“We’re delighted to see Colombia represented among the global community of sites committed to excellence in clinical research,” states Jacqueline Johnson North, CEO and Founder of IAOCR. “By achieving GCSA Site Certification, HIC–FCV is demonstrating leadership and a proactive commitment to international clinical research standards, both regionally and globally.”
Learn MoreTo learn more about IAOCR, the GCSA Global Site Certification Standard, and how we can support your organization on its quality and certification journey, contact Vicki Booth, Director of Marketing and Partnerships - email vbooth@iaocr.com / www.IAOCR.com
To learn more about Hospital Internacional de Colombia – FCV please contact Yira Guerrero, Head of Press and Protocol, based in Santander, Colombia, at yiraguerrero@fcv.org or +57 322 525 1793, or Pilar Salcedo, International Public Relations Specialist, based in South Carolina, United States, at internationalpr@fcv.org or +1 854 236 9726. Website: hic.fcv.org/co/