Hidra Investigación Clínica Becomes First in Mexico to Pursue GCSA Global Quality Certification, Setting New Benchmark for Latin American Clinical Trials
FOR IMMEDIATE RELEASE
Partnership with IAOCR/GCSA will implement the world’s only evidence-based quality standard for research sites across its network, promising to reduce trial risk and attract global sponsors.
MEXICO CITY – – Hidra Investigación Clínica, a leading clinical research site network, today announced it has become the first organization in Mexico to commit to achieving GCSA (The Global Quality Standard for Clinical Research Sites). This landmark initiative, supported by the new IAOCR/GCSA Americas hub, signals a new era of operational excellence and patient-centricity for clinical research in the region and is set to begin in August 2025.
This commitment positions Hidra Investigación Clínica at the forefront of a region-wide movement toward globally harmonized quality standards. By pursuing GCSA certification, Hidra aims to enhance its capabilities, provide greater assurance to international pharmaceutical and biotech sponsors, and further solidify Latin America's growing reputation as a premier destination for clinical research. The region's clinical research market is projected to see significant growth, including a 66% increase in oncology trial participation alone by 2040, making the adoption of global standards more critical than ever.
"We are committed to providing high-quality clinical research services based on international standards. Pursuing GCSA certification confirms our dedication to excellence and regional leadership," said Rafael Díaz-Treviño, General Manager at Hidra Investigación Clínica. "This is a strategic investment in our people, our processes, and our patients. It aligns perfectly with our existing ISO 9001:2015-certified quality culture and demonstrates our readiness to meet the highest global benchmarks."
The GCSA standard is awarded by the International Accrediting Organization for Clinical Research (IAOCR), a global leader in competence verification. The new IAOCR/GCSA Americas hub provides localized resources in Spanish and Portuguese to support sites throughout their certification journey.
"Bringing GCSA to Latin America empowers local sites to reach globally benchmarked quality, improve client confidence, and attract international sponsors," said Julio G. Martínez-Clark, President of IAOCR/GCSA Americas.
GCSA is the only internationally recognized, evidence-based quality standard developed specifically for clinical research sites. It assesses operational excellence across seven critical pillars: Patient Engagement, Feasibility, Study Start-Up & Initiation, Study Management, Workforce Process Quality, Site Business Strategy, and Governance. The GCSA standard was developed with the industry, for the industry, and is endorsed by leading global sponsors and CROs. By focusing on a structured approach to process improvement, GCSA certification provides international recognition of quality, increases a site's capacity and efficiency, and improves confidence for sponsors and participants.
The multi-site certification process will commence in Q3 2025, starting with a comprehensive gap analysis. The journey will continue with targeted training and process optimization in Q4 2025, followed by independent verification in Q1 2026. Hidra Investigación Clínica is targeting full certification across its sites in Mexico City, Querétaro, and Morelia by Q2 2026.
About Hidra Investigación ClínicaFounded in 2012, Hidra Investigación Clínica is a network of ISO 9001:2015-certified clinical research sites located in Mexico City, Morelia, and Querétaro. The organization conducts Phase I-IV studies across a range of therapeutic areas, leveraging strategic hospital partnerships and advanced diagnostic capabilities, including nuclear medicine, intensive care units, and on-site laboratories. Its mission is to conduct clinical research that improves patient outcomes and advances biomedical science through strict adherence to Good Clinical Practice (GCP) and national regulations.
About IAOCR and GCSAThe International Accrediting Organization for Clinical Research (IAOCR) is the global leader in competence verification and quality certification for the clinical research industry, trusted by sponsors, CROs, and regulatory bodies in over 40 countries. GCSA (The Global Quality Standard for Clinical Research Sites) is the only internationally recognized, evidence-based quality standard for sites. It was developed by a Global Advisory Board of industry leaders to provide a definitive framework for operational excellence and risk mitigation in clinical trials.
Call to Action: Organizations seeking world-class, patient-centric research partnerships in Latin America should contact Hidra Investigación Clínica to explore upcoming study opportunities. For more information on the GCSA certification process or to start your own journey toward operational excellence, visit https://www.iaocramericas.com/.
