Servier has research programs in 6 major fields of medicine. We are a major player in pharmaceutical research. We believe that our research should contribute to medical progress. It needs to be shared with external researchers. Sharing improves Research, Knowledge & Patient Care. This collaboration should be responsible and protect the patients’ rights. It is the key to successful data sharing. These principles drive our Transparency Policy on clinical data.
We think it is an important way forward to enhance global public health.
We share the results of our clinical studies publicly, whether the results are neutral, negative or positive. We share results and data in different ways.
They can apply on our Data Request Portal. Clinical trial data include protocols, raw data and clinical study reports. We redact personal data to protect the patients’ privacy. This commitment applies to all studies in patients submitted for new medicines (and new indications). The medicine should be approved in the EEA or US after the 1st January 2014. The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered for this commitment. This commitment also applies to studies in patients sponsored by Servier and related to products for which development has been terminated before approval. The studies should have enrolled patients after 1 January 2004.
We select registries that meet WHO criteria (EudraCT, Clinicaltrials.gov, ISRCTN…). We publish summaries of results on these registries. These will also be made available on this website.
We undertake to share with the public a lay summary. It will cover all interventional studies in patients ending after the 1st January 2018. These lay summaries are in line with recommendations from Medicines Agencies and written in collaboration with Patient Associations.
We publish the results of our studies (at least all phase 3 studies) in peer-reviewed scientific conferences and/or journals. We publish all results regardless of the study outcome. We submit articles within 18 months of the end of the study. This concerns all studies ending after the 1st January 2014.
We publicly certify that we have established policies and procedures to implement the EFPIA Data sharing principles. This public website means that our data transparency policy can be reviewed.
We adhere to the regulatory requirements in each country. Furthermore, we try to harmonize our Transparency policy on a global level.
US: United States
EEA: European Economic Area
WHO: World Health Organization
EFPIA: European Federation of Pharmaceutical Industries and Associations
Servier is a member of
Servier studies are mainly registered on