Rotherham Doncaster and South Humber NHS Trust (RDaSH) demonstrates excellence in clinical research with GCSA certification
Doncaster and Maidenhead, United Kingdom – January 28, 2025 – The Grounded Research team of the Rotherham Doncaster and South Humber NHS Trust (RDaSH) has been awarded the prestigious GCSA Global Quality Standard for Clinical Research Sites certification. This significant achievement establishes the Trust as a leader in clinical research. This certification results from a rigorous independent evaluation based on the globally recognized quality standards established by GCSA, reaffirming RDaSH's commitment to excellence in conducting clinical trials.
A quality seal in clinical research
The GCSA certification is the only internationally recognized quality standard for clinical research sites. It is awarded to organizations that have demonstrated excellence in the key areas supporting the conduct of world-class clinical trials, ensuring an exceptional experience for patients and sponsors.
To achieve this certification, the Grounded Research team at RDaSH demonstrated its ability to deliver clinical research of the highest quality, meeting specific criteria in seven fundamental areas:
Feasibility
Study initiation and startup
Patient engagement and participation
Study management and operations
Study closure
Governance
Business strategy and workforce quality
Heather Rice, Director of Research and Innovation at Grounded Research of RDaSH, emphasized: “Demonstrating adherence and commitment to global best practices is essential for NHS research teams. This provides trust and assurance to patients and offers an independent benchmark regarding the quality of our research.” She added, “Proving that we operate under the highest quality standards allows us to position ourselves as a reliable and valuable partner in conducting clinical research.”
A milestone in the trajectory of excellence of RDaSH
The acquisition of the GCSA certification is a testament to the clinical research infrastructure, operational excellence, and dedication of the RDaSH team. This recognition follows the previous milestone of the Trust in April 2023, when it became the first NHS Trust to achieve the Workforce Process Quality Certification (WPQC) for clinical research sites, awarded by the International Accrediting Organisation for Clinical Research (IAOCR). Sarah Everitt, VP of Operations at IAOCR and GCSA, commented: "By obtaining this certification, RDaSH has demonstrated that it not only meets but exceeds global standards in the management of clinical research sites. Its certification reinforces its position as a key player in advancing clinical trials and improving access to innovative treatments for patients in the region."
Elevating the standards of clinical research
IAOCR and GCSA certification processes are based on comprehensive evaluation frameworks developed in collaboration with industry experts and leaders. The GCSA quality standard was designed in consultation with a Global Advisory Council, composed of key stakeholders in clinical research, and it covers the seven critical business areas essential for delivering high-quality clinical trials. Complementing the GCSA certification, the WPQC certification provides a clear benchmark of the highest talent management and processes standards, ensuring that personnel are aligned with industry best practices.
While clinical research is a highly regulated sector, until the recent introduction of the GCSA, no defined global standards allowed sponsors and research organizations to select sites based on independently assessed quality criteria. The GCSA certification establishes this crucial standard, enabling clinical research sites to demonstrate their capabilities and differentiate themselves in a highly competitive market. Beyond the evaluation and certification process, GCSA offers practical support and collaboration to help sites meet the required standards and continuously improve their processes.