Phase I Clinical Trials for Development of Neurotherapeutics

The National Institute of Neurological Diseases and Stroke (NINDS) at the National Institutes of Health (NIH) has established a Master Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle for Phase I clinical trials focused on the development of neurotherapeutic agents. This full-service contract enables comprehensive clinical trial operations, spanning from protocol development through final clinical study report submission in support of Investigational New Drug (IND) submissions. The contract vehicle provides a turn-key solution for executing complex clinical research protocols specifically targeting neurological disease treatments and novel therapeutic interventions.

Task orders under this IDIQ are primarily awarded to contract research organizations (CROs) and academic research institutions, with PPD Development LP and Duke University emerging as frequent prime contractors. The typical task order values range from approximately $500,000 to $3.5 million, with performance periods generally extending 2-3 years and ultimate completion dates aligned with the master contract's June 30, 2026 deadline. Funding agencies include the National Institute of Neurological Disorders and Stroke, National Institute on Drug Abuse, and National Center for Advancing Translational Sciences, all operating under the Department of Health and Human Services. No set-aside designations have been used in the awarded task orders, and performance locations have included Durham, North Carolina, with pricing mechanisms predominantly structured as cost-plus-fixed-fee or cost-no-fee arrangements supporting critical neurotherapeutic research initiatives.