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 focuses on the business operations that underpin the delivery of high-quality, best-in-class clinical trials. Developed in response to industry demand, the distinctive GCSA Certification Mark signifies a site’s status as a ‘Trusted Global Partner’ for delivering world-class research for sponsors, CROs, and participants globally.
Ensuring business operational excellence (through GCSA Certification), in addition to evidencing clinical compliance and capability (through regulatory inspections and audits) enables sites to credibly demonstrate process excellence, participant and client engagement, and a continuous quality improvement approach that delivers world-class trials across the end-to-end clinical trials pathway.
The collaborative and supportive GCSA Certification journey assesses seven high-impact business process areas, cited by sponsors and CROs, as critical to the delivery of high-quality trials:
Feasibility
Study Start-Up and Initiation
Patient Engagement
Study Management, Operations and Close Down
Workforce Process Quality
Site Business Strategy
Governance
Achieving Distinction
Your Roadmap to Clinical Trial Site Excellence and Enhanced International Visibility
The structured and supportive GCSA Certification Journey guides sites through a comprehensive review, assessment and gap analysis process, leading to a tailored action plan that ensures the integration of global best practice business processes and procedures. The process supports improved efficiency and increased capacity, as well as providing solid foundations for scalable growth. Upon achieving Certification, sites gain enhanced international visibility, credibility, post certification marketing support and access to valuable networking opportunities with sponsors, CROs, and peer research sites.
GCSA certification enables:
Formal demonstration of quality and excellence
Improved confidence for participants, sponsors/CROs and staff
Enhanced leverage for business development activities to support the attraction of commercial research opportunities
Optimized business operational processes that improve efficiency and capacity
Readiness for scalable and sustainable growth
International recognition as a ‘Trusted Global Partner’ in clinical research
Representation on the IAOCR Global Best Practices Board
How and Why the GCSA Quality Standard Was Developed
The GCSA standard was developed in direct response to industry demand from sponsors and CROs. The requirement was for a standard that determined operational excellence in sites from a business and partner perspective. It was built to address key industry challenges and facilitate synergistic working between sites and sponsors/CROs to enable better participant experiences.
GCSA was developed by IAOCR over a four-year period in close consultation with a Global Advisory Board (GAB) made up of key stakeholders from the global clinical research industry, including leading sponsors, CROs, commercial and public health trial sites and Government organizations.
GCSA Certification assures sponsors and CROs of a site’s capability, validated through independent assessment against sponsor-defined quality standards and expectations relating to 7 critical business operational areas that underpin the delivery of world-class clinical trials. The GCSA quality mark denotes ‘Trusted Global Partners’ and provides a clear point of differentiation for sites in an increasingly competitive marketplace.
“As a sponsor of dermatology trials, the GCSA certification standard gives me confidence that sites are working to a global quality standard and have been independently audited by IAOCR. When a site is GCSA Certified I have confidence that they will be a high-quality partner for our clinical trials.”
Dr Sam Kerr
Global Sponsor
Chief Scientific Officer
“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
Global Sponsor
Study and Site Operations Country Head
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 quality & adherence to global best practices – builds trust with sponsors, CROs, and participants
Streamlining & optimizing business operations – increases efficiency and safety; reduces risks
Establishing robust SOPs – ensures consistent and reliable processes
Maximizing patient engagement – attracts and retains clinical trial participants
Improving feasibility and study start up – supports faster activation cycles and on target recruitment
Effective study management – streamlines processes from start-up to close-out
Ensuring workforce process quality – supports engaged, valued and competent staff; motivates teams and improves staff retention
Testimonials from GCSA Certified Sites
“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 independent GCSA assessment, we have been able to demonstrate and embed best practices and processes.”
Vicky Eyre
Re: Cognition Health (UK)
Director of UK Clinical Trials
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
AGA Clinical Trials
CEO
Press Release: AGA Clinical Trials (US)
“The GCSA certification process offered more than just validation – it was a true opportunity for reflection and growth. It enabled us to celebrate areas of strength whilst also identifying opportunities to further refine and enhance our processes. The Certification reinforces the credibility and quality of our research operations through independent external review. Ultimately, it supports our continued commitment to delivering high-quality experiences for both patients and sponsors.”
Sophie Mepham
ICON Group
Executive Manager for Research
Press Release: ICON Group (Australia)Certification Journey Highlights
Unrivalled understanding of your site’s business operations – critical to the effective delivery of world class clinical trials
Gap analysis report – identifying areas of excellence and areas for improvement/development
Support to achieve process excellence – provision of comprehensive recommendations and actions following gap analysis
‘Trusted Global Clinical Research Partner’ status – through achievement of the distinctive GCSA Certification Mark
Continual quality improvement – annual recertification process demonstrates commitment to continual quality improvement
Post-certification marketing support – share your success and enhance your international visibility with support form the IAOCR marketing team
Representation on the IAOCR Clinical Research Global Best Practices Board – raise your site’s profile and status by working alongside global sponsors, CROs and other certified sites on important industry initiatives.
Learn from our GCSA Clients
Trusted by...
