Commitment to Responsible Clinical Trial Data Sharing
EMD Serono’s Commitment to Responsible Clinical Trial Data Sharing
EMD Serono believes that as a biopharmaceutical company, the sharing of information related to company sponsored Clinical Trials is central to our mission. The sharing of clinical trial information enables the medical and scientific community to further develop the medical and scientific knowledge base and permits the public to make informed healthcare decisions. It is also one of the best ways to inform prescribers and patients about scientific findings relating to our medicines.
We are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: (a) safeguarding the privacy of patients (b) respecting the integrity of national regulatory systems and (c) maintaining incentives for investment in biomedical research.
For more information on EMD Serono’s commitment to Responsible Clinical Trial Data Sharing, click here.
Information Available for Researchers
Following approval of a new product or a new indication for an approved product in both the European Union and the United States after January 1, 2014, EMD Serono will share study protocols, anonymized patient level, and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon researcher request, as necessary for conducting legitimate research. Data will not be shared for products and indications approved prior to January 1, 2014. In addition, data will not be shared with EMD Serono competitors.
If you are an appropriately qualified researcher, please see below for more information on how to request data from EMD Serono.
All information must be submitted in English.
Before you Submit a Request
Please note the following: The Data Sharing Agreement found here is a template. EMD Serono suggests that you review the terms and conditions of its standard Data Sharing Agreement with the appropriate legal and/or contract personnel at your institution BEFORE submitting your Research Proposal. The terms of the Data Sharing Agreement are not negotiable.
On this website you will find a request form below that you are kindly asked to fill in and submit. Please review the forms carefully for required information before starting. Additional information on how to complete the forms and who is eligible is provided for you to download. After completing and submitting the Research Study Proposal Request Form below, please click on the submit button. You should then receive an e-mail automated receipt confirmation of your request.