At Pharmalys, Quality is more than just a word – it is our promise.
Quality can be defined as the standard of something as measured against other things of a similar kind, or the degree of excellence achieved. In clinical research, Quality ensures that clinical trials are conducted in full compliance with regulations, that data is robust and reliable, and that patients are protected and their rights respected.
At Pharmalys, we adopt a true culture of Quality. It is a collective commitment shared across the organisation. Our Quality team is always accessible when questions arise, providing clarity on SOPs, supporting issue resolution, delivering training on new procedures, regulations and guidance, and conducting audits to continuously strengthen the quality processes of Pharmalys, our providers and our clients.
Contributing to the Wider Quality Community
The Director of the Pharmalys Quality Management department is highly committed to his profession. Alongside his core responsibilities, he is an active member of the BPC News group.
Created approximately 25 years ago, BPC News brings together around 100 professionals in Quality Assurance, Regulatory Affairs and Clinical Operations from both public and private organisations. The group meets roughly every six weeks to exchange insights and share experiences on current topics of interest, such as ICH E6(R3) and its impact on investigator sites and Data Governance, lessons learned from inspections, personal data protection, and system audits.
These meetings are designed not as academic lectures, but as open forums that encourage discussion and peer exchange. Once a year, an external expert is invited to deliver a keynote presentation followed by an interactive discussion. In 2026, the guest panellist will present on AI applied to clinical trials: what about the validation process?.
BPC in Action: A Practical Working Group
As a complementary initiative, BPC in Action, dedicated to Auditors and QA Managers, was launched this year by Muriel Cottard, Senior Quality Assurance Consultant, supported by Christophe Baduel, Pharmalys Director of Quality Management. This new working group focuses on practical, peer-to-peer discussions and meets monthly.
The first meeting, held on 6 February 2026, was a great success. Participants expressed strong enthusiasm for the initiative, appreciating the opportunity to engage in focused discussions on concrete Quality Assurance topics.
BPC in Action is a pragmatic lunchtime roundtable operating under a confidentiality charter to which all participants adhere. During each focused 45-minutes session, members are invited to share and discuss practical, real-life topics directly related to their daily work. These discussions complement the BPC News meetings, allowing participants to share concrete and operational examples, compare approaches, seek advice on complex situations, address operational challenges, and explore regulatory interpretations – all firmly grounded in field experience.
Potential discussion topics could include:
- ‘AI in clinical Quality Assurance activities or in GCP audits’
- ‘Managing conflict and difficult situations with internal or external partners’
- ‘Auditing an investigator site: sharing challenges encountered, preparation practices, note-taking during the audit, etc.’
- ‘Regulatory interpretations of certain “grey areas’
At Pharmalys, we are proud to benefit from a Quality team that continually strives for improvement and excellence. They are a constant driving force behind our standards and play a vital role in supporting our mission: Better Health through Data Excellence. Learn more about Quality Management by Pharmalys.
