Pharmalys Ltd: Our Commitment to Quality

Jul 10, 2024 | Quality & Business Excellence

As an international Contract Research Organisation (CRO), Pharmalys Ltd has always been dedicated to delivering excellence in every service we provide, ensuring quality at every step.

Our Business Excellence and Quality Management team is integral to all our services, meticulously defining roles and responsibilities for all stakeholders. They identify corrective and preventive actions for process improvement, write and update Standard Operating Procedures (SOPs), and conduct various audits, including investigational site facilities, study data, trial master files, and investigator site files, as well as monitoring compliance. Read more: https://www.pharmalys.com/quality-assurance/

Since 2022, Pharmalys has partnered with Qualogy 2002 Ltd, an internationally recognised accreditation scheme managed by Tim Stiles. This partnership supports organisations in  implementing Good Clinical Laboratory Practice (GCLP) guidelines. These guidelines, initially produced in 2002 and co-authored by Tim Stiles, were published by the Research Quality Association and updated in December 2012. They provide essential guidance on quality systems for laboratories analysing samples from clinical trials (CTs). Widely adopted globally, GCLP guidelines are utilised by the World Health Organisation (WHO), pharmaceutical companies, research institutions, non-governmental organisations (NGOs), hospitals, CROs, and academic institutions.

Partnering with Tim Stiles allows us to actively contribute to the development and expansion of the GCLP accreditation scheme, distinct from our current activities at Pharmalys.

 

GCLP accreditation: a valuable achievement for laboratories participating in Clinical Trials

 

The analysis of samples is a crucial component of the CTs process. Ensuring that sample collection, analysis, and reporting meet high standards is essential for maintaining patient safety and producing reliable, accurate data in compliance with Good Clinical Practice (GCP) regulations.

GCLP provides unified guidance on the facilities, systems and procedures necessary for clinical sample analysis, promoting global consistency. This standardisation facilitates the mutual acceptance of clinical data by regulatory authorities worldwide, underscoring the value of GCLP accreditation for laboratories involved in CTs.

The GCLP accreditation scheme is designed for laboratories seeking to demonstrate to clinical trial sponsors and government agencies worldwide that they adhere to standards ensuring the reliability, quality, and integrity of their work and results. Established in 2003, the scheme currently includes over 80 laboratories from across Asia, the UK, Europe, Africa, the UAE, and USA, with ongoing interest from laboratories wishing to join. Participants range from hospital and central laboratories to company, research, and investigator site laboratories.

These accredited laboratories perform routine analyses or specialise in various methodologies essential for analysing clinical trial samples as per sponsor specifications. GCLP accreditation instils confidence in the accuracy and reliability of their reported results.

We take pride in promoting the importance of the GCLP accreditation scheme. Our role involves overseeing every stage of the accreditation process and actively contributing to the expansion of the network of accredited laboratories.

Pharmalys Ltd values its partnership with Qualogy 2002 Ltd as a significant enhancement to their commitment to quality in CTs.  With over 15 years of experience in the clinical research field, Pharmalys Ltd has developed an extensive and continually growing database of key opinion leaders, qualified researchers, investigators, and professional sites. Read more: https://www.pharmalys.com/feasibility-assessments/

We have also honed our expertise in identifying and evaluating productive clinical sites. Our comprehensive site identification process allows us to not only execute site selection thoroughly based on customer requests, but also propose a list of backup sites that can be quickly initiated if additional sites or replacements are needed. Read more: https://www.pharmalys.com/site-identification/

In conclusion, Pharmalys Ltd remains eager in its commitment to quality and excellence in CTs. Our partnership with Qualogy 2002 Ltd and our rigorous internal standards underscore our dedication to delivering reliable and accurate results. With over 15 years of experience and a continually expanding network of professionals and sites, we are well-equipped to meet the evolving needs of the clinical research field. Through our comprehensive processes and strategic collaborations, Pharmalys Ltd continues to set the standard for quality in CTs.

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