Inactive
Notice ID:W81XWH20VPA
The announcement services as a sources sought and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research and Development Command, Combat Ca...
The announcement services as a sources sought and shall not be construed as a solicitation or as an obligation on the part of the United States Army Medical Research and Development Command, Combat Casualty Care Research Program, the United States Army or the United States Army Medical Research Acquisition Activity. The United States Army Medical Research Acquisition Activity intends to award a research and development contract to procure services of an investigation new drug (IND) sponsor for the performance of Good Clinical Practice (GCP) compliant clinical trials leading to a new indication for Valproic Acid (VPA) for the treatment of patients with significant hemorrhage in accordance with government requirements. The contractor will manage the planning and execution of placebo controlled randomized multicenter phases 2 and 3 clinical trials in a variety of patients. The study will require subjects with high risk of significant hemorrhage using VPA as an adjunct to resuscitation to obtain indication approval from the U.S. Food and Drug Administration (FDA). The contractor will be required to be the regulatory sponsor for the product development effort including everything until New Drug Application (NDA) filing with the FDA. Accordingly the intended contractor will bear the legal responsibilities of sponsor under 21 CFR 312 Subpart D and retain control over the product development effort. This is not a request for proposal (RFP) or a request for quote (RFQ); this is strictly a sources sought. Neither unsolicited proposals nor any other kinds of offers will be considered in response to the sources sought. No contract will be awarded pursuant to this announcement.
