EMD Serono, USA
Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany

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.
Learn more about requesting information with the Summary of EMD’s Responsible Data Sharing Policy for Researchers.

Interested Researchers

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.
Step 1: Requesting Data
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.
Step 2: Research Validation
EMD Serono will evaluate the Research Proposal using a number of criteria, including but not limited to:
  • All documents submitted, complete, comprehensive and in English
  • Qualifications and experience of Lead Researcher and Research Team, including biostatistical competencies;
  • Scientific merit of the Research Proposal, including any unmet medical need and/or interest of patients/public health and a clear research hypothesis.
  • Evaluation of conflict of interest disclosure;
  • Whether is it feasible to anonymize the data without compromising the privacy of clinical trial participants, which EMD Serono is legally obliged to protect
  • Whether the data is available
  • Whether a publication/posting plan is in place.
Evaluation of the research proposal, as well as the qualifications and experience of the Lead researcher and team, will be conducted by appropriate and qualified person or board.

Step 3: Accessing Data
If you have received a favorable response you would then be eligible to access data based on these conditions:
  • Signing and returning EMD Serono’s standard Data Sharing Agreement before any access to data will be given (the terms of this Agreement are not negotiable)
  • You agree that data cannot be copied, stored and/or extracted from the secure server where you will be provided access to the data, you may, however, extract your analyzed results
  • You agree to EMD Serono’s Data Privacy Statement
  • Access time to  your data request will be of a fixed period which will be communicated to you
  • Data will be provided in CDISC SDTM format, analysis systems available: SAS, R
If a special request is considered, provision of data format will be communicated to you. You will be asked to provide a publication/posting plan.
I have read and understood the EMD Serono Data Privacy Statement and I consent to the processing of my personal data and information as described therein.*
I have read and understood the terms and conditions of EMD Serono’s standard Data Sharing Agreement attached and I confirm that I have provided this document to the appropriate legal and/or contract personnel at my institution and have obtained their permission to proceed with this submission.*
By making this submission, I have read and understood that EMD Serono may, from time to time, publicly disclose on its website: (1) your name, (2) the name of other researchers involved in the Research Proposal, (3) the name of your institution, (4) the title of the Research Proposal, (5) the EMD Serono-sponsored clinical study being accessed, (6) funding sources, and (7) a link to the resulting publication. By making this submission, you understand and agree that EMD Serono may, from time to time, publicly disclose on its website: (1) your name, (2) the name of other researchers involved in the Research Proposal, (3) the name of your institution, (4) the title of the Research Proposal, (5) the EMD clinical study being accessed, and (6) funding sources (7) link to the resulting publication.

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Please specify the clinical study you would like access to by referring to the ClinicalTrials.gov identifier or the NCT number (for example NCT1234567) *
If you have a unique identification code for your Research Proposal (e.g., an institutional study number), please provide it here *
 This Research Proposal is a re-submission of a Research Proposal previously submitted to EMD Serono.
 This Research Proposal is NOT a re-submission of a Research Proposal previously submitted to EMD Serono.
Title of Research Proposal *
Research Hypothesis/Objective being tested *
Research Proposal Rationale/Purpose including benefit to patients, science and/or public health *
Describe your data analysis plan (how you intent to analyze the data) *
 I intend to combine results with data from other sources.
 I DO NOT intend to combine results with data from other sources. If yes, please describe
If yes, please describe
Describe your publication and/or posting plan *
Name of lead researcher (title, first name, middle initial, last name):
Current position (job title, department/institution name and address) *
How long have you been working at your current position (years, months)? *
Contact email address * *
Contact telephone number * *
Previous positions (job title, department/institution name and address, start and end date) * *
Professional qualifications and/or memberships relevant to this research proposal
Evidence of biostatistical qualifications *
Five most recent and/or most relevant publications *
How many people are participating in this analysis (please note it will be required to provide additional information on their qualifications at a later time) *
Please identify all confirmed and potential/pending funding sources for the Research Proposal, including all research grants, scholarships, fellowships, endowments, awards, cooperative agreements, in-kind donations, consultancies, honoraria, and any other type of payments or funding from both public (e.g., government) and private (e.g., for-profit and non-profit companies) sources. If there is no funding for the Research Study, enter “None". * *
A conflict of interest is a situation in which financial or other non-financial personal considerations may compromise, or have the appearance of compromising, a researcher’s judgment in designing, conducting or reporting research. The Lead Researcher and every member of the Research Team, regardless of title or position, who is responsible for the design, conduct, or reporting of the research must disclose all financial and non-financial relationships within the past three years with EMD Serono, other pharmaceutical/biotechnology companies, or other third parties that could compromise, or have the appearance of compromising, the researcher’s judgment in designing, conducting or reporting the research. In addition, all researchers must disclose any potential competitive use of EMD Serono’s data. If no such potential competitive use is intended, state this. Describe how you plan to manage all actual or potential conflicts of interest. Examples of potential conditions and restrictions used to manage such conflicts include public disclosure, appointment of an independent monitor capable of taking measures to protect the research from bias, change of personnel or personnel responsibilities, etc. * *
If your Research Proposal is approved, describe how you will protect EMD Serono's data from unauthorized use, access and disclosure *
Please provide any additional information that you feel should be considered when reviewing your application
I hereby confirm that I have access to a sufficient information technology platform compatible with EMD Serono’s for purposes of undertaking the Research Proposal
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