We are dedicated to developing and providing innovative pharmaceutical products and solutions that address various medical needs. It encompasses a range of therapeutic areas, including oncology, neurology, and fertility, among others.

We aim to improve patient outcomes through research, development, and the delivery of high-quality healthcare solutions.

EMD Serono is committed to promoting the disclosure of clinical trials and responsible data sharing, ensuring compliance with global legal,regulatory and ethical standards while aligning with the principles of the biopharmaceutical industry.

Data will be made available to the researcher upon approval of a research proposal and the signing of a Data Use Agreement by the lead researcher and their institution.

• Clinical trials where there is a significant risk of re-identifying study participants, such as those involving rare diseases, single-center studies, or studies with fewer than 50 subjects.
• Clinical trials where data sharing is restricted by informed consent or where there are regulatory, legal, contractual, or other limitations.
• Clinical trials where data or documents are not available in English.
• Clinical trials that are subject to ongoing regulatory activities or publication plans.
• Research proposals that do not offer a novel analysis or conflict with additional planned or ongoing analyses by EMD Serono.
• Requests from individuals with potential or actual conflicts of interest or affiliations that raise concerns.
• Imaging data (e.g., DICOM files from x-rays, ultrasounds, MRI scans, etc.) cannot be shared.
• Genetic and genomic data cannot be shared.

• Approval of a product or a new indication by major health authorities, including the FDA, EMA, and PMDA (if requested), with no pending submission plans.
• Public availability of study results through the primary manuscript scientific publication or a disclosure on a clinical trial registry.
• Establishment of legal authority to share the data.
• Implementation of measures to ensure the protection of participant privacy.

If approval of a product is not sought or EMD Serono has globally discontinued the development of the product for all indications and has no plans for future development, EMD Serono shall make public the availability of such data within eighteen months after the global trial completion date. Requests from EMD Serono’s competitors outside Industry collaboration initiatives shall not be granted. Requests relating to products approved before January 1, 2014, and requests for legacy or discontinued compounds are reviewed through the same process.

• There is a potential or actual conflict of interest or competitive risk.
• The requested data is unavailable, not collected, or unsuitable for the research proposal.
• The objectives of the research proposal are deemed commercial or litigious.
• A clear scientific merit is not evident in the research proposal, as assessed by the IRP.
• In accordance with the U.S. Department of Justice Final Rule – Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern (28 CFR Part 202), we evaluate requests for studies involving U.S. participants on a case-by-case basis, particularly when researchers are from Countries of Concern or are Covered Persons.

• Anonymized individual patient-level datasets (STDM or ADaM) or aggregate-level datasets
• Redacted clinical study protocols and amendments
• Redacted statistical analysis plans
• Dataset specifications
• Case report forms
• Redacted clinical study reports
• Anonymization report

• The research objective can be achieved using the collected study data.
• The Informed Consents do not restrict the proposed research.
• The data is free from legal, regulatory, or contractual limitations.
• There are no competing publication plans.
• Study data and documents are available in English.
• The proposal does not have the potential to generate information that could identify individual research participants.
• There are no practical barriers to providing the data (e.g., issues with database formats or excessive operational costs for data preparation).
• The scientific rationale and relevance of the proposed research to medical science or patient care are clear, as assessed by the IRP.
• The proposed research plan (design, methods, and analysis) is capable of achieving the scientific objectives, as assessed by the IRP.
• The publication plan for the research is well-founded and justifiable, as assessed by the IRP.
• The plain English summary is clear and detailed enough for a non-specialist to understand.
• Any real or potential conflicts of interest that could affect the planning, conduct, or interpretation of the research, along with proposals to manage these conflicts.
• The qualifications and experience of the research team are adequate to conduct the proposed research.
• Data from U.S. participants accessed by Countries of Concern or Covered Persons must not exceed the bulk thresholds established by the U.S. Department of Justice Final Rule (28 CFR Part 202).

In certain circumstances, access to data may be declined by EMD Serono, for example, where there is a potential conflict of interest or an actual or potential competitive risk.