IST Process Overview
Submission of a Concept Overview
In order to submit a Concept Overview, an Applicant must first complete certain registration screens and submit a current curriculum vitae (CV). This is done via the EMD Serono IST System website: www.ist.emdserono.com.
Next, an Applicant fills out the Concept Overview page. The general information provided during the registration process will be used to pre-populate certain fields in the Concept Overview page. Applicants are required to provide the following information related to the proposed Concept Overview:
- Title of proposal
- Type of support requested (financial, drug or both) and an estimate of amount; include name of drug (if applicable)
- Study design
- Study rationale and unmet medical need
- Study hypothesis
- Study population
- Feasibility of enrolling proposed population
- Description of the unique or novel feature of the Study
- Study Budget
All Concept Overviews must be submitted via the IST System. Hard copies will not be accepted.
Review of Concept Overview
EMD Serono's Review Committee will review all Concept Overviews for scientific merit, innovation and clinical importance/potential impact on patients. The Review Committee will extend call backs to some Applicants to participate in the second step of the process, which is submission of a detailed Proposal. Applicants will be notified of the Review Committee's decision via email.
Oncology Concept Overviews Received:
- Concepts will be reviewed on a monthly basis.
Multiple Sclerosis, Reproductive Health and Endocrinology Concept Overviews Received:
- January 1, 2016 - January 15, 2016 will be reviewed in February
- January 16 - April 15, 2016 will be reviewed in May
- April 16 - July 15, 2016 will be reviewed in August
- July 16 - October 14, 2016 will be reviewed in November
- Any Concept Overview received between October 15 - December 31 will be reviewed in January 2017
Submission of IST Proposal
All Proposals must be submitted via the IST System. Hard copies will not be accepted.
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, 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 IST Requestor for the express purpose of presenting the study results at one scientific congress or meeting.
Costs that shall not be included in any IST 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 IST Requestor's normal business operations (e.g., electricity, phone, employee fringe benefits)
- Any "permissible" expenses which exceed fair market value
Review of Proposals
EMD Serono's Review Committee will review all Proposals and select a certain number of them for funding. Applicants will be notified of the Review Committee's decision via email.
If you are invited to submit a proposal the following timelines will apply:
- The proposal must be received within 6 weeks of concept approval. Proposals are reviewed on a monthly basis.
Multiple Sclerosis, Reproductive Health and Endocrinology Proposals:
- Invitation extended in January or February: Proposal must be submitted by March 18, 2016
- Invitation extended in May: Proposal must be submitted by June 17, 2016
- Invitation extended in August: Proposal must be submitted by September 16, 2016
- Invitation extended in November: Proposal must be submitted by December 16, 2016
If your Proposal 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 Quarterly Reports to EMD Serono
- Intellectual Property rights
- Publication requirement
EMD Serono requires IST Recipients to comply with all applicable laws, rules, regulations and industry codes related to clinical and/or non-clinical research. IST Recipients may be required by law to file an IND for the Study. IST Recipients are responsible for making the IND determination and filing for the IND, not EMD Serono.
For those Studies that require IRB/IACUC approval and/or an IND, IST Recipients must submit a copy of the approved IRB/IACUC and/or IND via the IST System.
Please note: All IRB/IACUC approvals must be received within four months of when EMD Serono executes the Grant Agreement. If this deadline is not met, EMD Serono reserves the right to rescind approval of the IST.
Clinical Trial Registration
IST Recipients are required to comply with all applicable laws, rules, regulations and industry codes governing registration of protocols and posting of results. IST Recipients should be identified as the "sponsor" on such registrations and postings, not EMD Serono. EMD Serono also encourages you and your institution to add your study to the FDA's ClinicalTrials.gov database or another trial registry website.
IST Applicants may request that EMD Serono provide marketed or investigational drugs for Studies. Once a Grant Agreement has been fully executed, the drug approved for the Study may be requested via the IST System. Requests for Study Drug require a minimum lead time of five business days (please note: EMD Serono only ships Study Drug from Monday to Thursday; Study Drug is not shipped on Fridays).
It is the responsibility of the IST Recipient to maintain the Study Drug and supplies in the appropriate conditions and to account for all Study Drug and supplies, including its receipt, usage, destruction or return. IST Recipients should contact the IST Coordinator for questions regarding Study Drug, including information on how to return Study Drug.
Adverse Event Reporting
IST Recipients are responsible for complying with all applicable laws, rules, regulations and industry codes concerning adverse event reporting. The Grant Agreement will include information on how to submit an adverse event to EMD Serono.
In order to ensure the appropriate progress of research, EMD Serono requires that you submit an update on your study on a monthly basis. Monthly status reports are due the first business day of each month. These monthly status reports must be submitted via our website. Milestone payments will not be made if a monthly status report has not been submitted for the most recent month.
All Investigators must provide EMD Serono with a detailed Final Report which outlines the research findings.
EMD Serono expects the results of ISTs to be published or presented, whether the results are positive or negative. Publications must take the form of either (1) a manuscript submitted to a peer-reviewed journal, or (2) an abstract submitted to a scientific or medical congress. All publications must be sent to EMD Serono in advance of submission, according to the timeframe set forth in the written agreement. All publications should comply with recognized ethical standards concerning publications, authorship and disclosure of funding, including without limitation the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, www.icmje.org, established by the International Committee of Medical Journal Editors.