MEDIATOR INFORMATION 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. Within Servier, and in response to an unsolicited request, Investigator Initiated Trials (IITs) are studies with scientific and medical rationale developed by an independent Third-Party Sponsor for which Servier provides support with funding and/or supply of Servier products. They are also known as: Investigator Initiated Studies, Investigator Initiated Research or Investigator Sponsored Research This guidance provides Servier policy and process relating to Third-Party Sponsored Studies. Eligible studies: 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: Writing independently the study concept and submitting it to Servier for support request Developing study protocol and patient related documents Acting as insurance taker Preparing and obtaining Competent Authorities/ Ethics Committee approvals and fulfill Sponsor’s Legal Obligations Performing the study according to the Protocol and in compliance with local and international laws and regulations (e.g. ICH-GCP, registering to clinicaltrials.gov) Monitoring and providing study progress to Servier as stated in the agreement Planning drug supply, labeling, and distribution throughout the study (if applicable) Reporting all safety issues to appropriate Competent Authorities as per regulations and to Servier as per agreement Independently publishing study results and forward a copy of study report as per agreement to Servier Fulfilling regulatory requirements related to clinical trial data transparency What can you expect from Servier ? Provide scientific medical review and comment on study concept/protocol Provide agreement template including Safety obligations and Intellectual Property rights on the results Inform the Third-Party Sponsor on all safety obligations for the type of study as per Servier Standard Operating Procedure Provide Third-Party Sponsor with needed information on the supplied drug product, in particular safety information via provision of the Summary of Product Characteristics (SmPC) for registered products and/or the updated Investigator Brochure (IB) for products or indications under development Provide study drug and/or funding as per agreement Process safety events received from Third-Party Sponsor Review any publication for medical accuracy and eventually final study report as per agreement Perform medical safety review 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. A signed two-sided Confidentiality Agreement CV as the principal investigator leading the research (including GCP training) Written request Exhaustive Study Synopsis Concept according to Servier template Funding Request and/or Drug supply needs 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: Final Protocol reviewed by the Global Review Committee Pharmacovigilance specifications in accordance with regulatory obligations and Servier requirements Conditions of product supply, when applicable Payment schedule based on agreed milestones when applicable We thank you for soliciting Servier for your research project TERMS OF USEDATA PRIVACYCOOKIE MANAGEMENTCONTACT USREPORT A SIDE EFFECT ©2020 SERVIER LABORATORIES