London and Maidenhead, United Kingdom, 21 February 2023 – Re:Cognition Health’s commercial clinical research operational processes have undergone a rigorous evidence-based assessment to achieve all seven GCSA quality standards. The first network of commercial sites to undertake the GCSA assessment process; GCSA provides reassurance to sponsors, CRO’s, staff and ultimately the patients, that trial sites have been independently assessed against robust global quality standards.
Re:Cognition Health has eight centres in the UK and USA for international trials of disease-modifying and new symptomatic drugs for Alzheimer’s disease and other neurological conditions.
Using a comprehensive framework, Re:Cognition Health has achieved the GCSA quality standard in the following key business areas: Workforce Quality Accreditation (WQA); Patient Engagement; Feasibility; Study Start Up & Initiation; Study Management & Closedown; R&D Business Strategy and Governance. The GCSA quality mark highlights high performing sites and provides an independent assessment and report on the quality, efficiency and effectiveness of current operational processes, GCSA is part of IAOCR the international accrediting organisation for clinical research.
“We take what we do very seriously, because of the impact our trials can have on our patients and their families. We wanted to ensure we were providing the best quality service to our patients, their families, the Sponsors and CRO clients, whilst also developing our team. Through the GCSA accreditation process, we have been able to demonstrate best practices and processes. We are very proud of our fantastic team and we are delighted that their hard work has been recognised with this accreditation.” Vicky Eyre, Clinical Operations Director.
The GCSA gold standard has been ratified by a Global Advisory Board of industry experts from a broad range of global and UK organizations and leads to a distinctive, internationally-recognized quality mark. This evidences that participating sites are operating to the highest global standards and builds confidence for patients, clinical trial sponsors and CROs.
“The Re:Cognition Health staff were extremely enthusiastic and responsive to the GCSA process, demonstrating the deep-rooted commitment within the organization to ensure they are working to the highest industry standards,” explained Jacqueline Johnson North, Co-Founder of GCSA “The team were honest and open which enabled us to get a true picture of the clinical trials operational processes and the challenges involved, showing there is an incredibly positive attitude overall within the company to perform the trials to the best of everyone’s capabilities.”
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; allowing sites to evidence and communicate their capabilities and differentiate in a crowded and increasingly competitive marketplace. Beyond the assessment and accreditation 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 accreditation.
To learn more about GCSA and how we can support your business please visit gcsaaccredited.org, get in touch via email: info@gcsaaccredited.org or call:
• International: +44 1628 784906
• US Toll Free: +1 855 209-2335
• UK: 01628 784906
For further press information please contact: Alina@alinawallace.com
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Notes to editors
About Re:Cognition Health:
Re:Cognition Health is a pioneering brain and mind clinic specialising in the diagnosis, treatment and care of people showing symptoms of cognitive impairment or mental health concerns. Clinical services include traumatic brain injury, neurology, children’s neurological conditions, Alzheimer’s and dementia, mental health, long Covid and cannabis. The Re:Cognition Health Clinics in Birmingham, Bristol, London, Surrey, Plymouth, Winchester, Washington DC and Houston are also major centres for international trials of disease-modifying and new symptomatic drugs for Alzheimer’s disease and other neurological conditions. The multi-disciplinary team work collaboratively to provide a full-service, patient-centred approach using the latest progressive medical research and evidence-based treatments.
About GCSA:
GCSA, part of IAOCR, 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 processes so that they can deliver first-class services to patients and sponsors. 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 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.