Inactive

The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and int... The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it is deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. At this time, the complexity as well as quantity of requirements for support services for ACTIV- 2 have significantly increased based on “real time” clinical trial implementation data as well as evolving scientific requirements. Specifically, the following significant increases of ACTIV-2 key clinical trial activity drivers have transpired since July 10,2020: Number of sites – over 346% increase in the number of Phase 2 sites (41 to 183) and over 317% increase in the number of Phase 3 sites (96 to 400); Number of screened patients – over 13% increase for Phase 2 screened patients (2,201 to 2,492) and over 57% increase in Phase 3 screened patients (8,901 to 14,000); Number of enrolled patients – over 33% increase for Phase 2 enrolled patients (1,320 to 1,760) and over 87% increase in Phase 3 enrolled/completed patients (5,340 to 10,000); Monitoring requirements – over 33% increase in Phase 2 monitoring requirements and over 67% increase in Phase 3 monitoring; The period of study is extended from December 31, 2021 to May 31, 2022. As a result of these increases in clinical trial support activities, the Government will require additional support to address these needs. The objective of this acquisition is to procure 360 FTEs to be delivered to the Government during the period March 1, 2021 through May 31, 2022. These additional resources are needed to provide the support as listed above.