Clinical Research Operations and Management (CROMS)   2

Background
The National Institute of Dental and Craniofacial Research (NIDCR) has relied on support for intramural and external programs through the incumbent contractor with clinical research management and operations expertise. This support has allowed the Institute to have access to technical, regulatory, and administrative expertise and resources that are not available in-house. The clinical coordination efforts by NIDCR’s Office of Clinical Trials Operations and Management (OCTOM) staff, in collaboration with the contractor support, has led to a robust, centralized and standardized approach to the management of the Institute’s clinical research studies.
The NIH is committed to continuous enhancements to its stewardship and expectations for monitoring and oversight to support high quality research.

Work Details
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’s Representative (COR).
Eight distinct performance areas have been identified including Contract Continuation, Administration, Overall Project Management and Transition-Out Plan; Dedicated Onsite/Remote Contractor Support; Risk-based Clinical Site Monitoring; Data and Safety Monitoring Committee Support; Safety Surveillance Consultation; Regulatory Submission Support and FDA Interface Coordination; Statistical and Protocol Design Review and Consultation; General Maintenance and Update of NIDCR’s Information Management Systems.

Period of Performance
Base Period: 12 Months, Option 1: 12 Months, Option 2: 12 Months, Option 3: 12 Months, Option 4: 12 Months

Place of Performance
The contractor is not expected to be on site.