Sponsor Investigator Support Program
Investigator-Initiated Clinical Trials (IIT) are pivotal to advancing science and health care. The Sponsor Investigator Support Program (SISP) is dedicated to supporting the complexities of IITs from protocol design, document development, FDA submission, safety monitoring plan review, monitoring and more.
Request a consultation for SISP Services: email@example.com
- Protocol and supplemental document review during study development
- Assisting in preparation and initial IND/IDE submission to FDA
- Managing follow-on submissions to FDA
- Safety monitoring plan review/development
- Safety monitoring of eligible trials
- Good Clinical Practice guidance and resource navigation
Our experienced staff (firstname.lastname@example.org) provide required assistance to Investigator-Sponsors and their study teams in preparing, submitting, and maintaining applications to the Food and Drug Administration (FDA) in the conduct of FDA-regulated clinical trials.
For Federally regulated clinical trials (under and IND or IDE), SISP can provide local monitoring services including development of a clinical monitoring plan, risk-based monitoring and Good Clinical Practice guidance.