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
- Workforce Process Quality
- R&D Strategy
- Governance
A world-class provider of clinical research
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
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 recognizable 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
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 Profile/ Standing, Reputation and Influence
- Demonstrating adherence to global best practices: Builds trust with sponsors, CROs, and stakeholders
- Attracting new business: through respected and recognized quality standards.
- Streamlining clinical trial business operations and reducing risks: increase efficiency and safety
- Enhancing staff engagement and recognition: Motivates teams and improves staff retention
- Quality assurance recognition: Builds confidence with stakeholders and patients
- Establishing robust SOPs: Ensures consistent and reliable processes
- Maximising patient engagement: Attracts and retains patients
- Improving feasibility and study start up: Supports faster and on target recruitment
- Effective study management: Streamlines processes from start-up to closedown
- Ensuring workforce process quality: Supports engaged valued and competent staff.
- Optimizing organisational and operational business strategy: ensures efficient and quality trial delivery
- Providing post-certification marketing support: Boosts visibility and credibility
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).
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 recognizable 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
“Having the quality of our workforce processes externally assessed is really important – it’s vital that we are open and hold ourselves up to scrutiny. This Gold Accreditation helps us do that, as well as recognising the hard work and dedication of our team. The IAOCR process also showed us areas where we have opportunity to improve so we can remain a provider of high-quality research for all of our communities and can continue to make a real difference to patients’ lives.”
Jodie Keyworth – Head of Business Development, Grounded Research, RDaSH
Full case study: RDaSH (Rotherham, Doncaster and South Humber)
