Notice ID: 75N92025R00010
Related Notice: 75N92025R0314
Offerors are solicited only from small business concerns.
The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to support clinical research investigating the cause, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. This research, conducted through its extramural and intramural research programs, includes studies of diverse design, clinical settings, size, and complexity.
The objective of the contract renewal is to provide support to NIDCR extramural and intramural staff to effectively oversee and manage the Institute’s clinical research program. The contract will provide NIDCR staff with adjunct technical expertise, administrative and logistical support, as well as electronic systems and other tools to assure efficient and high-quality conduct of the clinical research studies NIDCR supports. Specific tasks performed will vary by clinical study and clinical site, and will be dependent on the study’s protocol, standard operating procedures, and the roles/duties assigned to the Contractor by the NIDCR Contracting Officer’s Representative (COR).
- Twelve (12) distinct performance areas have been identified as follows:
- Task Area 1: Contract Continuation, Administration and Overall Project Management
- Task Area 2: Dedicated Onsite/Remote Contractor Support
- Task Area 3: Assessment and Assistance for Clinical Site Preparation, Study Documents and Reports
- Task Area 4: Risk-based Clinical Site Monitoring
- Task Area 5: Data and Safety Monitoring Committee Support
- Task Area 6: NIDCR Safety Reporting Program
- Task Area 7: Regulatory Submission Support and Food and Drug Administration (FDA) Interface Coordination
- Task Area 8: Statistical and Protocol Design Review and Consultation
- Task Area 9: Review of NIDCR Human Subjects Research Website Pages
- Task Area 10: General Maintenance and Update of NIDCR’s Information Management Systems
- Task Area 11: General Logistical, Administrative and Technical Support/Consultation
- Task Area 12: Contract Transition-Out Plan
A pre-proposal conference will be held with prospective offerors at on Tuesday, January 07, 2025, from 2:00PM – 3:00PM via Teams. Please use the link below to register and access the meeting.
The period of performance of this contract shall be from 9/30/2025 through 9/29/2026.
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