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28-Jan-2025

Rotherham Doncaster and South Humber NHS Trust (RDaSH) Demonstrates Clinical Research Excellence Through GCSA Certification

Doncaster and Maidenhead, United Kingdom, 28 January, 2025 – The prestigious GCSA Global Quality Standard for Clinical Research Sites has been awarded to the Grounded Research team at Rotherham Doncaster and South Humber NHS Trust (RDaSH). This certification marks a significant achievement that positions the Trust as a leader in the field of clinical research. The certification journey follows a rigorous, independent assessment against GCSA’s globally recognised quality standards, affirming RDaSH’s commitment to delivering the highest level of clinical trial excellence.

 

The GCSA Certification is the world’s only internationally recognised quality standard and certification for clinical trial sites. It recognises organisations 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 — the Grounded Research Team at RDaSH has demonstrated its ability to provide the highest quality and efficiency in clinical research.

 

Demonstrating adherence and commitment to global best practice is essential for NHS research teams. It offers confidence and assurance for patients and provides an independent benchmark to our communities around the research we undertake,” explains Heather Rice, Director of Research & Innovation, Grounded Research at RDaSH. “By proving that we are operating to the highest of quality standards, it provides our clients evidence that we are a trusted and valuable partner for the delivery of clinical research. Furthermore, our workforce is strengthened by attracting, engaging with, and retaining staff who work at the highest possible standards.”

 

RDaSH’s certification is a testament to its clinical research infrastructure, operational excellence, and the dedication of its workforce. The Trust’s achievement of GCSA Certification demonstrates the standards it continues to strive, and follows their success of becoming the first NHS Trust to achieve the gold standard Workforce Process Quality Certification (WPQC) for Clinical Research Sites in April 2023, awarded by the International Accrediting Organisation for Clinical Research (IAOCR).

 

“By achieving this certification, RDaSH has shown it not only meets but exceeds global standards in clinical research site management,” explains Sarah Everitt, VP Operations, IAOCR and GCSA. “The Trust’s successful certification also positions it to play a pivotal role in advancing clinical trials and improving access to cutting-edge treatments for patients in the region. This milestone builds on RDaSH’s earlier success in achieving the IAOCR Workforce Process Quality Certification and further demonstrates the outstanding dedication and skill of their research team.

 

The IAOCR and GCSA certification processes are based on comprehensive assessment frameworks which have been developed with and ratified by global industry experts and opinion leaders. The GCSA 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 and 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. Complimenting the GCSA Certification, the WPQC provides a clear benchmark of the highest workforce process standards for both those working within the organisation to pride themselves on, as well as for sponsor’s and CROs looking for a ‘trusted global clinical research partner’ with demonstrable evidence of quality workforce standards.

 

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 and GCSA how we can support your business 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 RDaSH and Grounded Research

The Grounded Research Team provides the Research & Innovation (R&I) function at RDaSH. It has a purpose-built community Clinical Research Facility and dedicated research staff, including medics, nurses, pharmacy and clinical studies officers, with the skills needed for swift set up and smooth delivery of trials. The team are winners of the Nursing Times Clinical Research Nursing Award 2019 and Winner of ‘Research Team of the Year’ 2022, from the National Institute for Health and Care

Research Clinical Research Network.

 

RDaSH provides a range of mental health, learning disability, drug and alcohol services and community

health services across Rotherham, Doncaster and North Lincolnshire. For further press information please contact: Jennie Smith on jennie.smith17@nhs.net

 

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

 

Rotherham Doncaster and South Humber NHS Trust (RDaSH) Demonstrates Clinical Research Excellence Through GCSA Certification

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Last Updated: 29-Jan-2025