Investigator Initiated Studies (IIS)
Investigator Initiated Studies (IIS) supports external, non-commercial sponsors conducting independent clinical, observational, real-world evidence, and health outcomes research to explore scientific questions.
Funder: Boehringer Ingelheim
Due Dates: No application deadline stated
Funding Amounts: Financial support and/or drugs for approved studies; no award amount stated
Summary: Supports independently proposed, non-commercial clinical, observational, real-world evidence, and health outcomes research.
Key Information: A non-commercial sponsor bears sole responsibility for the study; Boehringer Ingelheim is not its regulatory sponsor.
Description
Boehringer Ingelheim’s Investigator Initiated Studies (IIS) program supports unsolicited research proposed and conducted independently by external, non-commercial sponsors. Its scope includes pre- and post-marketing interventional clinical trials conducted under current ICH-GCP guidelines, non-interventional studies such as observational and real-world evidence research, and non-commercial health economics and outcomes research. IIS are generally exploratory or proof-of-concept studies rather than registrational studies.
The external sponsor develops, finances, manages, and operates the study, including selecting sites, training staff, and monitoring progress. Boehringer Ingelheim may provide financial support, drugs, or both for an approved study, but does not serve as its regulatory sponsor.
