Understanding clinical trials
Clinical trials refer to the series of scientific studies conducted in humans that validate the research and development stages in the discovery of a new medicine.
It is an essential step that is subject to rigorous regulatory controls.
- Servier clinical trials
- Investigator Initiated Trials
Servier clinical trials
We believe that in order to develop medicines that better meet patient needs, we need to involve them in the process as early as possible, right from the R&D stage, either directly or through patient organizations.
Integrating the patient into every stage of R&D leads to closer ties between basic and clinical research, giving rise to what is known as translational research.
In this way, patients play a fundamental role in the process of developing new treatments.
Understanding translational medicine
Translational medicine takes a multi-disciplinary approach involving researchers, clinicians and patients, and forms a major component in clinical research and development.
Harnessing digital technology to speed up the research process
At Servier, digital technology and data increase agility and efficiency to speed up the research process, the identification procedure and clinical trials. They are an essential component of our R&D and develop a more detailed understanding of patients.
SCORE is the digitalization program for our clinical trials. It encourages remote dialogue between patients and medical and scientific teams by enabling them to access data in real time. The goal? To facilitate decision-making.
Five principles of transparency
The Servier Group complies with the five principles of transparency set out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) for clincial trials.
Servier publishes 100% of results from clinical trials carried out in Europe on the European Union Clinical Trials Register (EUCTR) website.
Our clinical development centers
Servier boasts a network of 15 clinical development centers, which are organized into three hubs in the North and South America, Europe and Asia-Pacific. They conduct local clinical trials in the Group’s therapeutic areas. They are operated by teams of highly qualified Servier employees.
Independent trials initiated by third-party sponsors
At Servier, we understand the importance of Investigator Initiated Trials (IIT) carried out by independent third-party sponsors. 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.
Non-interventional* (e.g. disease understanding, drug usage) or interventional with products under development or already registered.
*for non-interventional studies, funding only might be provided.
Third-Party Sponsor is qualified
By training and experience to undertake the proposed research and may include, but is not limited to institutions, academic or cooperative groups, or group of physicians.
The study remains independent and under the full responsibility of the Third-Party Sponsor. No undue influence nor operational support from any Servier employee will be provided to conduct or drive the study.
Roles and responsibilities of each party will be described in an agreement.
What are the responsibilities of the third-party sponsor?
The Sponsor has the responsibilities for all aspects of the study as per ICH-GCP, including but not limited to:
What can you expect from Servier?
IIT Concept Submission & Review
As a Health Care Professional, you should contact your Servier Local Medical Affairs’ Representative in your country or ask for a Medical Representative in the Servier local country office.
Documents you need to submit to the Servier Local Medical Affairs representative:
The study concept will be assessed internally by a Local Committee; if accepted, it will undergo review by a Global Review Committee. Study concept clarifications may be required by the respective committees at any stage of the review process. If the concept is approved, a contractual Agreement will take place.
Conflicts of Interests – Transparency
Servier follows a strict code of ethics which ensures compliance with regulations and ethical standards. Research proposals are assessed according to Servier research areas of interest and strictly on their scientific merit and alignment with the Company´s overall research, global development strategy, assurance that conditions for patient safety are met.
Servier is committed to maintain Transparency and Integrity in all interactions with healthcare professionals.
As required by agreement and regulation, Servier discloses financial support provided to researchers and their institutions. Funding of research must not exceed local fair market value, nor be used for expenses not associated with the conduct of the research.
The agreement will contain:
We thank you for soliciting Servier for your research project.