HIDRA Investigación Clínica Becomes First Clinical Research Site Network in Mexico to Commit to GCSA Global Clinical Site Certification

HIDRA Investigación Clínica Becomes First Clinical Research Site Network in Mexico to Commit to GCSA Global Clinical Site Certification

Maidenhead, UK – 28 July 2025 — HIDRA Investigación Clínica has become the first Site Management Organization (SMO) in Mexico to commit to the International Accrediting Organization for Clinical Research’s (IAOCR) Global Clinical Site Certification (GCSA) program. This significant milestone underscores HIDRA’s commitment to excellence and leadership in Latin American clinical research. With clinical research sites in Mexico City, Querétaro, and Morelia, HIDRA is setting a new benchmark for quality and international standards across the region.

GCSA Site Certification is the only global, evidence-based quality standard designed specifically for clinical research sites. Developed by IAOCR in collaboration with industry leaders from the pharmaceutical and biotechnology industries, CROs, sites, regulators, and healthcare professionals, the GCSA framework assesses and quality assures clinical research practices across seven key business operational areas, ensuring high-performing sites who deliver consistent quality and best-in-class experiences for patients and clients.   

“At HIDRA Investigación Clínica, we are committed to delivering world-class clinical research services that prioritize the safety, experience, and well-being of our patients,” said Rafael Díaz Treviño, General Manager, HIDRA. “At the beginning of August 2025, we are aligning our research business operations with the GCSA best-practice standards across all our sites. This internationally recognized certification reflects our dedication to operational excellence and high-quality performance across feasibility, patient engagement, study start up and delivery, governance, and more. We are extremely proud to lead the way as the first SMO in Mexico pursuing GCSA certification.”

“We are thrilled to welcome HIDRA Investigación Clínica as the first organization in Mexico to join the GCSA program,” said Jacqueline Johnson North, CEO of IAOCR. “Their commitment to global best practices in clinical research will have a lasting positive impact on patients, sponsors, and the broader healthcare ecosystem in Latin America. As demand for high-quality clinical trial sites continues to grow across the region, GCSA-certified sites are increasingly sought after by international sponsors and CROs seeking trusted, high-performing global research partners.”

The GCSA certification process is based on a comprehensive assessment framework; the certification journey is collaborative and supportive, involving a robust review, assessment and gap analysis process. The GCSA Global Quality Standard for Clinical Research Sites was developed by IAOCR in close consultation with a Global Advisory Board of key stakeholders and leaders from across the industry. This Standard assesses the following seven core business operational areas identified by Sponsors and CROs as being critical to the delivery of high-quality clinical trials: Governance; Site Business Strategy; Workforce Quality; Patient Engagement; Feasibility; Study Start-up & Initiation; and Study Management, Operations & Close Down.

Whilst clinical research is a highly regulated industry, until now there have been no established standards by which sites can demonstrate that they are able to meet the expectations of sponsors, CROs and patients, and no way for sponsors or CROs to select clinical research sites based on clear quality standards which have been independently assessed at the organizational level. GCSA sets this much-needed industry standard for research sites to strive for and achieve; it allows sites to evidence and communicate their capabilities and differentiate in a crowded and increasingly competitive marketplace. Beyond the assessment and certification process, where required, GCSA will deliver individual, practical support on the areas for development to meet the standards and will work collaboratively with sites to achieve certification.

To learn more about IAOCR, the GCSA standard, and how we can support your organization please visit iaocr.com and/or email info@iaocr.com. Alternatively, you can call:

• International: +44 1628 784906
• US Toll Free: +1 855 209-2335
• UK: 01628 784906

For further press information please contact: pr@iaocr.com

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Notes to editors

About IAOCR

IAOCR is the International Accrediting Organization for Clinical Research.  Established in 2011, IAOCR works collaboratively with key industry stakeholders across the clinical research landscape to pioneer global best practice standards for sites, organizations and clinical research professionals. IAOCR’s portfolio of global quality standards, certifications and accreditations have been developed specifically for the clinical research industry and are valued and adopted by sponsors, CROs, commercial and NHS sites, supply chain organizations and clinical research professionals worldwide.

Through robustly verifying competence of clinical research professionals and quality assuring clinical research business and workforce processes, IAOCR works with organizations to reduce risk to patients, clinical research and reputations, improve compliance and bring valuable new treatments to market more quickly and safely.

All IAOCR’s quality standards and assessment frameworks have been built in close collaboration with industry experts globally. Sites, companies, charities and professionals achieving IAOCR certification and accreditation standards are provided with distinctive certification marks, formally demonstrating organizations that are committed to delivering globally consistent and high-quality clinical research.

We believe that clinical trial patients anywhere in the world deserve the best protection in terms of rights and wellbeing. Therefore, in addition to providing certification, accreditation, training and consultancy services, IAOCR works with industry leaders and regulators around the globe to raise standards and improve the clinical research landscape. To find out more visit: iaocr.com

About GCSA

GCSA is a global quality standard for clinical research sites set across seven key business operational areas. It ensures clinical trial sites are working to robust and effective business operational processes across the end-to end clinical trial pathway, so that they can deliver best-in-class services to patients and sponsors/CROs. The GCSA framework was developed over 4 years with industry research and engagement. It has been ratified by a Global Advisory Board of leading industry representatives from the not-for-profit and commercial sector, including leading global Sponsors and CROs, the NHS and other leading healthcare organizations.

The standard has been built to address key industry challenges and facilitate synergistic working between sites and sponsors to enable better patient outcomes. It provides potential sponsors with an assurance of capability through passing independent assessment based on standards and expectations specified by sponsors. Furthermore, GCSA aims to increase clinical research through alignment with commercial requirements. To find out more visit: iaocr.com