Search results for: trial regulatory sponsor

NOTE: The Government does not indemnify its partners.CURRENT REGULATORY SPONSOR: The current regulatory sponsor is The Surgeon General, Department of the Army (DA). The U.S. Army Medical Research and Development Command (USAMRDC) Office of Regulated Activities (ORA) provides regulatory-sponsor support and oversight for the trial. USAMMDA has partnered with USMRDC ORA for their support through an interagency agreement.

The purpose of this acquisition is to provide for clinical trials sponsor and regulatory management support services to the National Cancer Institute (NCI), the Center for Cancer Research (CCR), and CCR investigators.

, as well as agent distribution support for select Division of Cancer Prevention (DCP) and non-NCI sponsored treatment trials.In accordance with being a regulatory sponsor of clinical trial research, the PMB is responsible for maintaining NCI registration and credentialing information for its investigators and associates, which allows them to participate in sponsored trials. 

, as well as agent distribution support for select Division of Cancer Prevention (DCP) and non-NCI sponsored treatment trials.In accordance with being a regulatory sponsor of clinical trial research, the PMB is responsible for maintaining NCI registration and credentialing information for its investigators, sub-investigators, and associates, which allows them to participate in sponsored trials. 

Anticipated Task 1 activities include (but are not limited to):• Manufacture (cGMP) of bacteriophage therapeutic product suitable for clinical investigation in Phase 1 / 2 clinical trials;• Conception and execution of appropriate regulatory strategy (e.g., submission of Investigational New Drug [IND] application and other FDA-compliant responsibilities); conduct of Phase 1 / 2 clinical trial as the regulatory sponsor; accordingly, the development

TRIAL MASTER FILE (TMF) AND OTHER REGULATOR SUPPORT SERVICES Solicitation ID/Procurement Identifier: 75N93021D00038 Ultimate Completion Date: Tue Apr 30 17:00:00 GMT 2024

applicationsDescribe any current collaborations/partnerships with entities experienced in the design and conduct of preclinical studies for U.S. regulatory applicationsRegulatory sponsorship and execution of human clinical trials for safety and efficacy testing and/or FDA Animal Rule clinical trials where necessaryDescribe experience in serving as regulatory sponsor and obtaining FDA product approval(s)Appendix 1.