At Genentech, rigorous and groundbreaking science with real human impact is at the core of what we do. We apply this science in our R&D activities to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics. Investigator initiated clinical studies play a valuable role in our overall R&D approach.
Do you have an idea for an Investigator Initiated Study (IIS)? We welcome unsolicited proposals from qualified sponsors with promising ideas in our areas of strategic interest. Well-written, scientifically sound studies that enhance the understanding of our medicines, improve patient care, and spark new ideas for disease-related research will be considered. Our medical science personnel are available to guide you through each step in the process, from concept pre-approval to submitting the final budget and protocol.
Investigator initiated studies (IIS) are clinical studies initiated, developed, designed and managed by a qualified sponsor who assumes sole responsibility for conduct and management of the study. We work with a broad range of sponsors including, but not limited to, the following:
We support the following types of Investigator Initiated Studies:
Support for an approved IIS may come in various forms including supplying medicines, funding, material and/or information as allowed under local laws and regulations.
The following are not considered investigator-initiated studies:
There are three main steps in our IIS approval process and our medical science personnel are available to guide you each step of the way.
1. Discuss Concept with Your MSL
Your MSL can help with pre-approval by discussing your concept with the study review team and providing you with feedback
2. Submit Your Proposal
A link inviting you to complete your proposal in the IIS portal will be sent to potential sponsors whose concepts are of interest
3. Submit Final Protocol
If your proposal is approved, you will be asked to submit further details including budget and a final protocol in the IIS portal.
Research proposals will be reviewed and approved based on scientific merit and alignment with our areas of strategic interest. We evaluate all funding requests against local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.
Investigator Initiated Studies are an important part of our R&D activities, and we hold all sponsors to the same high standards to which we hold ourselves. To be considered for support, a sponsor must fulfill the following requirements:
In accordance with the research agreement, sponsors must also:
Before support can be initiated, the following documents must be in place: