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At Re:Cognition Health, we are proud to announce a monumental achievement: we have become the first organization to earn the prestigious GCSA Certification in both the US and Europe. Achieving GCSA – The Global Quality Standard for Clinical Research Sites underscores our commitment to clinical excellence, highlighting the dedication of our teams in both regions to provide world-class care for patients participating in our groundbreaking clinical trials for Alzheimer’s disease and other neurological conditions.
The GCSA Certification is a hallmark of quality in clinical research, awarded only to sites that demonstrate adherence to global best-practice standards. This certification was granted following a rigorous assessment conducted by the GCSA Assessment Team at the International Accrediting Organization for Clinical Research (IAOCR). The certification journey included a thorough review and gap analysis across seven essential business operational areas critical to the successful delivery of clinical trials.
What GCSA Certification Means for Re:Cognition Health
The GCSA global quality standard evaluates excellence in the following areas:
- Feasibility
- Study Start-Up and Initiation
- Patient Engagement
- Study Management, Operations, and Close Down
- Workforce Process Quality
- Site Business Strategy and Governance
Through this comprehensive assessment, Re:Cognition Health USA demonstrated a strong commitment to innovation, patient care and clinical trial delivery. Our engaged workforce, diverse patient inclusion efforts, and efficient processes ensure clarity in roles and responsibilities across all levels of operation. Additionally, our feedback mechanisms ensure continuous improvement, which is crucial for maintaining our status as leaders in the field of clinical research.
Mostafa Hassan, MBBCH, Director of Clinical Trials, USA at Re:Cognition Health, commented on this incredible achievement, “We are thrilled to have achieved the GCSA quality standard and certification – it’s truly a testament to the hard work and dedication of the entire Re:Cognition Health US team. We’re confident that this certification will further enhance our commitment to excellence in clinical trials and patient care.”
The Importance of GCSA Certification for Patients and Sponsors
For patients and sponsors alike, the GCSA certification provides assurance that Re:Cognition Health operates to the highest international standards. The quality mark indicates that our research sites have been independently assessed and certified against robust global standards, positioning us as a “Trusted Global Partner” for the delivery of clinical trials.
Sarah Everitt, Chief Quality & Client Officer at IAOCR, reflected on the process, “It was a delight to work with the Re:Cognition Health US team on the GCSA certification journey. Everyone we spoke with was professional, positive and enthusiastic about their work, and it is clear employees feel supported by their managers.”
The GCSA standard was developed with the guidance of a Global Advisory Board consisting of industry experts, sponsors, and contract research organizations (CROs). In a competitive and highly-regulated industry like clinical research, this certification sets an essential benchmark for operational excellence and demonstrates Re:Cognition Health’s dedication to providing the highest quality patient and sponsor journeys.
Setting a New Industry Standard
In an industry that lacks consistent benchmarks for clinical trial site quality, the GCSA certification is a pioneering development. Until now, there has been no standardized way for research sites to independently prove their capabilities to sponsors and CROs. With this certification, Re:Cognition Health is able to clearly demonstrate our ability to deliver world-class clinical trials while meeting the expectations of both patients and sponsors.
By setting a higher standard, GCSA enhances clinical research participation and inclusion, ensuring that more patients can benefit from new treatments being brought to market more quickly and safely.