Investigator Sponsored Studies (ISS)

Through our Investigator Sponsored Study (ISS) program, Alkermes supports investigator sponsored research on our marketed products and/or our targeted disease or therapeutic areas of interest. 

In an ISS, the investigator, as the study sponsor, assumes responsibility for all aspects of the research, including:

• Study design
• Ensuring appropriate institutional, regulatory and ethics committee approval
• Study conduct, including responsibility for ensuring appropriate medical safeguards, adequate record keeping, medical monitoring, adverse event reporting and medical supervision
• Analysis, interpretation and communication of the results (e.g., publications and submissions to conferences and journals after review by Alkermes)

Investigators who are awarded support through Alkermes’ ISS program will be required to submit a final study report/summary to Alkermes at the conclusion of the study.

Alkermes is currently only reviewing projects which request a supply of VIVITROL® (naltrexone for extended-release injectable suspension) and/or placebo.  If you are an investigator looking to submit a project proposal requesting Alkermes’ product only, please email ISS@Alkermes.com for an application. Please note that a submission of proposal does not guarantee Alkermes support.