Investigator Sponsored Study (ISS)

What is an Investigator Sponsored Study (ISS)?
An investigator sponsored study (ISS) is a study that is initiated and conducted by an external researcher who is not an employee of the pharma company which only funds it. Medical teams usually have a portal or some mechanism through which potential researchers can submit proposals for ISSs that are then reviewed by Medical and R&D teams and may or may not be funded depending on feasibility, strategic rationale, and budget. ISSs are usually conducted with the intent of only furthering the science around a drug and not for inclusion in drug labels.