Servier
Clinical trials
Clinical trials refer to the series of scientific studies carried out in humans that validate the research and development stages in the medicine discovery process. They are a crucial step, and subject to rigorous regulatory controls, in obtaining a marketing authorization and determining the optimal use of a medicinal product to ensure therapeutic benefit for patients.
Servier’s expertise
HIGH SCIENTIFIC STANDARDS
The Group’s clinical trials are managed by expert teams with high, exacting standards. Proper trial conduct requires good organization, involving teams responsible for international coordination and local teams present in 18 countries, to make it possible to manage clinical trials worldwide.
The global presence of Servier R&D therefore plays a fundamental role in the scientific influence of the company, allowing the development of innovative medicines corresponding to different needs of patients.
INVOLVING PATIENTS
Servier is committed to involving patients, directly or through patient associations, to develop medicines that best meet their needs. Patient representatives are already involved in 25% of Group clinical trial protocols in order to make sure all aspects of a disease and any inherent constraints are accounted for.
Accelerating research through digital technology
Digital technology and data processing increase agility, efficiency, and productivity to speed up the research process, the iterative molecule identification procedure, and clinical trials, while also developing a more detailed understanding of patients.
SCORE, the Servier program that digitizes clinical trials, falls within this ambition as it encourages remote dialogue between patients and medical and scientific teams by providing access to data in real time, therefore making it easier to make decisions.
The FederateS platform, meanwhile, is an intuitive and collaborative workspace for sharing and enhancing data within teams, to accelerate the various research stages.
Servier publishes 100% of the results of its European clinical trials on the European Union Clinical Trials Register website.
5 clinical trial transparency principles
Servier complies with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) 5 clinical-trial transparency principles in its clinical trials.
- For new medicines marketed in Europe and the United States, Servier provides researchers with access to its clinical data through its Data Request Portal. This access also includes authorized new indications.
- Servier’s studies involving patients are recorded in public registers and summaries of study results since 2004 are made available to the public.
- Servier is committed to disseminating its results summaries to the general public in accessible language.
- Servier publishes the results of its studies, whether positive or negative, in scientific literature.
- Servier hereby certifies that it has the necessary policies and procedures in place to apply these principles within the Group.
Investigator initiated trials
Servier recognizes the importance of Investigator-Initiated Trials (IITs) conducted by third-party sponsors. For this purpose, Servier is committed to support medical and scientific research which contributes to better understand the Group’s therapeutic solutions as well as to explore new opportunities to address unmet patient medical needs.
