GCSA – The Global Quality Standard for Clinical Research Sites
The World’s only internationally recognized global quality standard and certification for clinical trial sites that facilitates achievement of operational excellence and the delivery of world-class patient and sponsor journeys. The evidence-based 7-Module assessment and certification process provides you with the tools to provide the highest quality and efficiency in the following high-impact areas:
- Feasibility
- Study Start-Up and Initiation
- Patient Engagement
- Study Management, Operations and Close Down
- Workforce Process Quality
- Site Business Strategy
- Governance
Your journey to world-class status as a provider of clinical research
Experience the transformative benefits of GCSA certification and position your site as a world-class provider of clinical research and a ‘Partner of Choice’ for clinical trials.
The GCSA Global quality standard was developed in consultation with opinion leaders within Pharma/Biotech, CROs, Government, Regulatory Authorities, NHS and commercial sites, NIHR, HRA, and the International Accrediting Organization for Clinical Research (IAOCR).
GCSA certification provides reassurance to sponsors, CROs and ultimately to patients, that your research site has been independently assessed and quality assured against the robust global best-practice standards ratified by the industry, ensuring the delivery of safe, effective and efficient clinical trials.
Demonstrate your commitment to quality assurance and growth
GCSA provides a system of assessment, gap analysis, improvement support and independent quality assurance certification for clinical trial sites.
Embarking on the GCSA assessment and certification journey provides your site with an evidenced-based framework to review and improve processes, streamline operations, improve capacity and reduce risk. Areas of high-performance are identified in addition to providing a roadmap for continual quality improvement, assuring sponsors, CROs and patients of your capability to deliver world-class clinical trials.
Enhance site recognition and visibility
GCSA Certification provides a clear point of differentiation for sites and sets a recognized industry standard for research, enabling sites to evidence and communicate their capabilities and competence and differentiate themselves in a crowded and increasingly competitive marketplace.
The GCSA quality standard responds to industry demand for clearly identifiable sites, and the quality mark denotes ‘trusted partners’ who are committed to quality and put patients at the heart of their research.’
By ensuring your services are independently quality assured against current and industry-defined global best-practice standards, your Clinical Research Site is positively positioned in the minds of sponsors and CROs.
Testimonials
“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 assessment, we have been able to demonstrate best practices and processes.”
Vicky Eyre, Director of UK Clinical Trials – Re: Cognition Health (UK)
Full case study: Re: Cognition Health
“At AGA Clinical Trials, we are dedicated to demonstrating how we are a global center of excellence and the GCSA and IAOCR certifications were the logical next steps for us to achieve our mission of improving health and quality of life for our patients. The GCSA and subsequent IAOCR certification processes were in-depth and detailed, which allowed our team to reflect on our working processes beyond the core assessment. We’re delighted with the results because we are truly committed to working to the highest Industry standards.”
Dr. Maria Graber, CEO, AGA Clinical Trials (US)
Press Release: AGA Clinical Trials (US)
“Achieving full GCSA certification has provided us with a thorough understanding of our pathways and allowed us dedicated time to celebrate what we do extremely well and plan where we need to improve. As the first NHS site to achieve full GCSA certification signals that we work to the industry-defined global quality standard for clinical research sites, an achievement that we are actively promoting to commercial sponsors and CROs.”
Leslie Mokogwu, Head of Research and Innovation – Royal Berkshire NHS Foundation Trust (UK)
Press Release: Royal Berkshire NHS Foundation Trust (UK)
Inspire your team
For your clinical research staff, achieving GCSA certification both acknowledges their hard work and reflects the value they bring to your organization. The review process is supportive, inclusive and empowering and involves your team on the journey to certification.
The workforce process quality assessment – one of the 7 modules in the GCSA assessment framework – ensures your site has robust and effective procedures in place to ensure competent and confident staff who are engaged and working to the highest standards.
Raise your Site’s Profile, Reputation and Influence
Our comprehensive evidence-based certification process supports sites around the world including commercial, NHS and academic clinical trial sites by:
Demonstrating adherence to global best practices:
Attracting new business:
Through respected and recognized quality standards.
Streamlining clinical trial business operations and reducing risks:
Increases efficiency and safety.
Enhancing staff engagement and recognition:
Quality assurance recognition:
Establishing robust SOPs:
Maximising patient engagement:
Improving feasibility and study start up:
Effective study management:
Ensuring workforce process quality:
Supports engaged valued and competent staff.
Optimizing organizational and operational business strategy:
Ensures efficient and quality trial delivery.
Providing post-certification marketing support:
IAOCR and GCSA – Our Credentials and Quality Assurance
The GCSA global quality standard for clinical research sites is the only internationally recognized certification for sites. The GCSA framework was developed over 4 years in consultation with opinion leaders within the NHS, NIHR, HRA, Government, Regulatory Authorities, Pharma/Biotech, CROs and commercial research and the International Accrediting Organization for Clinical Research (IAOCR).
Our framework continues to evolve in response to changes in regulation and best practice with the support of a Global Advisory Board. The board is comprised of leading industry representatives from both the public and commercial sectors, including leading global Sponsors and CROs, NHS and commercial clinical research sites.
Broad and high-level client participation ranging from numerous large research focused NHS Trusts to established UK, US, Australian and New Zealand commercial clinical trials site networks. Existing high levels of client satisfaction are already testimony to the quality and transformative benefits of the GCSA certification journey
Certification Journey Highlights
Unrivalled understanding of your research site’s business operations
Our unique evidenced-based assessment process focuses on the seven operational areas critical to successful clinical trial delivery.
Identify areas of both high-performance and opportunities for development
Receive an in-depth review and gap-analysis report that includes recommendations to improve quality.
Achievement of the distinctive and recognized GCSA Certification and quality mark
Communicate your global quality assured and certified status to the wider industry and your patients.
Demonstrate your continued commitment to quality
Reassess and revalidate your progress, quality and commitment to continuous improvement with the GCSA annual reassessment.
Post-certification marketing activities
Share your success as an award-winning site with support from the GCSA and IAOCR marketing teams.
Testimonials from the Global Advisory Board
“Ensuring best-in-class global standards in terms of people and processes plays a big part in reducing risk in clinical research… The independent Global Advisory Board has unanimously ratified the GCSA accreditation standard for clinical trial sites, ensuring a robust standard for sites that can be adapted to fit with any country across the globe.”
Dr Suki Balendra – Life Sciences Lead | LCRN North West London Core Team; Imperial College Healthcare NHS Trust
Full case study: London North West London University Hospital
“As a board member for the GCSA Global Advisory Board, it is possible to see the difference that this certification for the global quality standard for sites will make to the ongoing delivery of clinical trials in our ever-challenging environment. The benefits of the certification include transparency for both sites and sponsors, enabling reassurance and trust in the commitment to the delivery of the highest quality research and facilitation of true synergistic partnerships across the clinical trial landscape. ”
Fiona Shields – Study and Site Operations Country Head, Novartis
