Pharmalys is pleased to announce that, effective from 2025, we have taken on the full management of the Good Clinical Laboratory Practice (GCLP) Accreditation Scheme, which we have co-managed with Tim Stiles of Qualogy 2002 Ltd for the past two years. This marks an important milestone for Pharmalys and continues our commitment to enhancing clinical research quality worldwide.
The GCLP Accreditation Scheme has been a vital part of clinical trials since 2003, helping laboratories meet international standards and ensure the integrity of data produced in the research process. As a trusted partner in clinical trial management, Pharmalys has worked closely with clinical trial facilities, providing training and support to laboratory staff during site visits. This hands-on involvement has allowed us to contribute to the growth of the GCLP accreditation community and gain invaluable insights into the complexities of clinical research labs.
The Significance of GCLP Accreditation
The GCLP Accreditation Scheme aims to ensure that laboratories involved in clinical trials meet the highest standards of quality and integrity, which are critical to successful clinical research outcomes. The World Health Organization (WHO) recognised the importance of these standards and adopted GCLP as guidance for their laboratories in 2009, reinforcing its global relevance.
Including laboratories from across the globe – such as hospital, central, private, research, and investigator site labs – the scheme plays a significant role in safeguarding the reliability of clinical trial data. Laboratories participating in the GCLP scheme perform a range of activities, from pharmacokinetics (PK) and routine haematology to non-routine sample analysis, like immunology. By becoming part of the GCLP Accreditation Scheme, laboratories gain recognition, improve operational efficiency, and bolster their credibility, which is essential in the highly regulated and competitive field of clinical research.
Pharmalys’ Role
Pharmalys is honoured to continue the legacy of Tim Stiles, whose expertise and dedication have shaped the GCLP Accreditation Scheme since its inception. Under his leadership, the scheme has expanded and grown in reputation, earning the trust of laboratories worldwide. Our team is fully committed to maintaining and further developing this important initiative. GCLP Handover letter_TStiles
We are excited to take the lead in managing the scheme and enhancing its reach. Our experienced staff have already assessed numerous laboratories for GCLP compliance. Below you will see a map outlining the 70+ locations of the clinical laboratories that are already part of the GCLP Accreditation Scheme.
How Laboratories Can Join the GCLP Accreditation Scheme
Laboratories interested in joining the GCLP Accreditation Scheme can contact our team by email gclpaccreditation.info@pharmalys.com. Once an application is submitted, our team will assess whether the laboratory aligns with GCLP standards. If accepted, the laboratory will undergo a comprehensive audit to evaluate compliance, after which an accreditation certificate will be issued.
The scheme’s accreditation process involves a thorough assessment of laboratory practices, with the potential for critical, major, or minor findings, and the issuance of a certificate based on the level of compliance.
Pharmalys is committed to maintaining the highest levels of confidentiality and impartiality
As we take over the full management of the GCLP Accreditation Scheme, Pharmalys is committed to maintaining the highest levels of confidentiality and impartiality. The scheme operates independently within Pharmalys, ensuring that all information is handled with the utmost respect for integrity and transparency.
We thank Tim Stiles for his dedication and invaluable contribution to the GCLP Accreditation Scheme and look forward to continuing this important work as we build on the foundation he established for the scheme.
For further information on the GCLP Accreditation Scheme, including how to apply, please contact our team by email gclpaccreditation.info@pharmalys.com.
