NIH Sources Sought: National Institute of Dental and Craniofacial Research (NIDCR) Clinical Research Operations and Management (CROMS)

Notice ID 75N92023R0196

As part of its overall research mission, the National Institute of Dental and Craniofacial Research (NIDCR) supports clinical research aimed at answering critical questions on the cause, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. This research, conducted extramurally through the funding of research grants and cooperative agreements, as well as within the intramural research program, includes studies of diverse study design, clinical settings, size, and complexity.

The objective of the contract renewal is to provide clinical research management, oversight and operations support for selected clinical research studies supported by the NIDCR’s extramural and intramural research divisions. The contract will provide NIDCR staff with systems and tools to assist in the effective oversight and administration of its clinical research program. In addition, it will provide adjunct expertise and resources to assure rigorous and efficient clinical study documentation, clinical site monitoring, data and safety monitoring, data management support, statistical support, and regulatory compliance. 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). TASK AREAS: Thirteen (13) distinct performance areas have been identified as follows: Task Area 1: Contract Continuation, Administration and Overall Project Management Task Area 2: Onsite Contractor Support Task Area 3: Review of NIDCR Human Subjects Research Website Pages Task Area 4: Assessment and Assistance for Clinical Site Preparation, Study Documents and Reports Task Area 5: Clinical Research Training and Education Content Task Area 6: Regulatory Submission Support and FDA Interface Coordination Task Area 7: Risk-based Clinical Site Monitoring Task Area 8: NIDCR Safety Reporting Program Task Area 9: Statistical and Protocol Design Review and Consultation Task Area 10: Data and Safety Monitoring Committee Support Task Area 11: General Maintenance and Update of NIDCR’s Information Management Systems Task Area 12: General, Logistical Support, Administrative Coordination and Technical Support…

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