The work that happens before the first participant enrolls and after the last one exits is real, substantial, and chronically underfunded. This session focuses on quantifying and negotiating for startup activities such as feasibility, regulatory submissions, contracting, training, site initiation, and system builds, as well as closeout, record retention, and ongoing administrative effort. We will discuss how to build defensible startup fee structures, when to seek non-refundable terms, and how to account for studies that never enroll. The session also covers administrative costs that span the study, including monitoring visit support and query resolution. Attendees will leave with concrete methods for capturing work that is too often absorbed as overhead.
Suzanne Rose - Executive Director of Research - Stamford Health