Investigator Sponsored Studies for Neurology & Immunology

The purpose of this page is to provide information on investigator-sponsored studies involving approved EMD Serono drugs or devices in Neurology & Immunology. EMD Serono gives higher priority to research that has the potential to address specific unmet medical or scientific data needs. Some general areas on which research may focus include:drugs or devices in Neurology & Immunology

Neurology & Immunology

• Clinical studies involving approved EMD Serono drugs or devices.
• Observational studies, such as epidemiology studies and certain health outcomes research studies where the primary focus is the scientific understanding of the disease.
• Other types of research on disease states, including diagnostic screening tools, which involve no EMD Serono drugs or devices.

At the present time we are only accepting innovative ISS studies in Multiple Sclerosis.

Several forms of support may be approved by EMD Serono's Review Committee, including:

• Funding to pay for trial-related expenses based on fair market value that are directly related to the research protocol.
• Providing drugs or devices for use in the research.

Study Budget
Our rules and restrictions on permissible and impermissible study expenses are as follows:

• All expenses associated with the conduct of investigator sponsored research must be identified in the detailed study budget in the application.
• The amount of all expenses must not exceed fair market value of the expenses associated with the research. Fair market value includes, among other things, consideration of the relevant market and geographic region.
• Expenses shall only be requested for research-related goods and services that are legitimate, reasonable and necessary for the conduct of the research and that are actually utilized in the conduct of the research.
• All payments must be milestone-based and not results based. In addition, payment shall not be made in one lump sum prior to the start of research.

Permissible direct study costs include without limitation:

• Subject-related costs
• Non-EMD Serono drugs and clinical supplies, while EMD Serono does provide funding for placebo, in general it does not supply the placebo, nor does EMD Serono provide blinded study drug.
• Study-related personnel costs (for personnel dedicated to the Study), but may not include the cost of any fringe benefits for the personnel
• Diagnostic fees and services
• Data management expenses
• Statistical services - this cost should be limited to $2,500, absent special circumstances that are documented
• Institutional overhead - in general, the amount of institutional overhead is limited to 25% of the total research budget. An amount in excess of 25% may be approved by the Review committee, in its discretion, upon a factual showing of necessity.

Permissible indirect study costs may include:

• Publication costs (e.g., medical writing to prepare manuscript, manuscript submission fee, etc.) - this cost should be limited to $2,500, absent special circumstances which must be documented
• IRB review fees - this cost may include initial IRB submission fee and all applicable renewal fees
• Costs of reasonable travel, lodging, congress registration (if required to make presentation) and related expenses of the ISS Requestor for the express purpose of presenting the study results at one scientific congress or meeting.

Costs that shall not be included in any ISS Proposal include:

• Start-up funds to establish new clinical research programs or to expand an existing program
• Purchase of capital equipment or software
• Hiring of staff that are not dedicated to the Study
• Costs of travel, lodging, or related expenses of the Applicant for purposes other than presenting Study results at a scientific congress or meeting
• Expenses relating to the ISS Requestor’s normal business operations (e.g., electricity, phone, employee fringe benefits)
• Any "permissible" expenses which exceed fair market value

How to Apply
To apply for a grant for an Investigator Sponsored Study, follow the instructions on the US STARTone portal, https://startone.vibrantm.com.  

ISS Review
EMD Serono's Review Committee will review all applications for scientific merit, innovation, clinical importance/potential impact on patients and alignment with our areas of interest. 

The Review Committee may have follow up questions about your application, in which case we will contact you. Applicants will be notified of the Review Committee's decision via email.

Grant Agreement
If your application is approved, you will be sent a written grant agreement which will set forth your obligations with respect to the study.

You will have eight weeks to review, sign and return the grant agreement. If the grant agreement is not returned within eight weeks, the grant may be withdrawn. 

Some of the topics addressed in the Grant Agreement include:

• Funding: amount and payment schedule (if applicable)
• Drug - amount (if applicable)
• Adverse Event Reporting
• Requirement to submit Monthly Reports to EMD Serono
• Intellectual Property rights
• Publication requirement

We are interested in supporting studies that:  

• investigate novel medical or scientific issues
• do not duplicate prior or ongoing global, regional or local studies or another investigator-sponsored study
• further inform the benefit/risk profile of Cladribine­ Tablets­ in­ a­ real­ world­ setting
• are patient-reported outcome studies with validated tools or robust methodology to enable validation
• research treatment sequencing
• investigate special populations
• further inform the understanding of Cladribine Tablets‘ mechanism of action

EMD Serono is required by federal and state law to disclose payments and other transfers of value to healthcare providers, their related entities, and US teaching hospitals.