Solicitation: 75N92020Q0061
The NHGRI requires a contractor that offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including DSMB services, Prime Review Board Services, and Genetics Training and Certification; (3) IT and analytical solutions, including bioinformatics, imaging, and website services; and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be able to comprehensively apply these services to provide leadership and support for the current request for protocol monitoring and data management support services and further scope as applicable after protocols are finalized. The contractor should be able to assign a dynamic team of qualified personnel who have experience in clinical trial design and regulatory expertise.
The OCD requires senior level statisticians to assist in the development and execution of clinical research protocols. Some pre-clinical studies also require statistical expertise provided by this contract. Issues to be addressed include power analyses, sample size, group analyses, trends, and stopping rules, as well as more complex topics.
Finally, the OCD requires administrative assistance to run the Institute’s DSMB. This committee serves the NHGRI Institutional Review Board (IRB) by reviewing clinical protocols in which there is an intervention, especially if a placebo is involved. Contract support is needed for arranging meetings, recording minutes, and communicating with members of the DSMB. The contractor also provides formal, written reports to the Director, NHGRI, and to the NHGRI IRB, as required by the DSMB charter. A member of the Contractor’s staff shall serve as Executive Secretary of the DSMB.
NHGRI requires a contractor that is equipped with all the required resources to provide the requested services. All the tasks related to this project require the entity to have in place the necessary network and personnel to successfully achieve all deliverables which allows for continuity in the completion of the work and the final product.
