MIAMI, May 8, 2025 /PRNewswire/ — Amavita Heart and Vascular Research Services LLC the research arm of Amavita Heart and Vascular HealthTM, a leading clinical research organization, is proud to announce it has successfully achieved the GCSA Global Quality Standard for Clinical Research Sites. This milestone certification follows the recent success of Amavita’s Principal Investigator, Dr. Pedro Martinez Clark, who recently achieved the QM-IAOCR Internationally Qualified Clinical Research Investigator Accreditation standard. This further reinforces the organization’s commitment to operating at the highest international standards.
To secure both quality standards, Amavita Research has undergone a rigorous evidence-based assessment of their site’s business operational processes that underpin the delivery of world-class clinical trials for GCSA and for the individual staff accreditation, robust assessment of the core role-specific competencies for Clinical Research Investigators. This achievement underscores Amavita Research’s dedication to embedding and maintaining best practices in clinical trial management, patient safety, and regulatory compliance. This joint achievement provides reassurance to sponsors, CROs, staff and ultimately the patients, that trial sites have been independently assessed against robust global quality standards and that research is in safe hands. It also provides a solid platform for Amavita Research’s continued growth, based on the solid foundations of independently quality assured best-practice processes.
“We are thrilled to receive the GCSA site certification, which is a testament to our team’s dedication to conducting clinical trials with the highest standards of quality and integrity,” explains Pedro Martinez-Clark, founder and medical director at Amavita Research. “This achievement not only validates our efforts but also enhances the confidence and trust of our sponsors and participants in the research we conduct and positions us as a research center of excellence in the cardiovascular field.”
The GCSA Certification is the world’s only internationally recognised quality standard and certification developed specifically for clinical trial sites. It recognizes sites that have demonstrated excellence across the critical business operational areas that underpin the delivery of world-class patient and sponsor experiences across the end-to-end clinical trials pathway. By meeting the specific criteria across seven key areas – ranging from feasibility and study start-up to patient engagement and governance — Amavita Research has demonstrated its ability to provide the highest quality and efficiency in clinical research.
“Amavita Research are a professional team, and it is clear from working with them through the GCSA certification that they have implemented a suite of clear working processes to support the efficient and successful running of their clinical trials,” summarizes Colette Donaghy, director of and assessment, IAOCR and GCSA.
Both IAOCR and GCSA use comprehensive assessment frameworks that have been developed with and ratified by Industry experts. The GCSA Global Quality Standard for Clinical Research Sites was developed with the support of a Global Advisory Board of key stakeholders and experts from across the industry. IAOCR’s accreditation standards for clinical research professionals are built with international taskforces with role-specific subject-matter experts. In addition to the IAOCR Investigator Accreditation, all seven areas of the GCSA quality standard were met which included: Feasibility; Study Start-up & Initiation; Patient Engagement; Study Management, Operations & Close Down; Governance; Site Business Strategy and Workforce Quality.
Whilst clinical research is a highly regulated industry, until recently with the introduction of GCSA, 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.
About IAOCR
IAOCR is The International Accrediting Organization for Clinical Research. We are the only organization in the world to accredit Clinical Research Professionals to international standards. Through robustly verifying competence, IAOCR reduces risk to patients, clinical research and reputations – whilst improving compliance and bringing valuable new treatments to market more quickly and safely.
IAOCR competence verification, process assessment and accreditations have been built specifically for the clinical research industry in collaboration with industry experts globally. They provide quality standards and visible professional certification marks to companies, charities and public health organizations that are committed to 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 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 trial sites set across seven key 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
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SOURCE Amavita Heart & Vascular Health
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