Attachment 2: IDIQ Statement of Work parent TOs

STATEMENT OF WORK (SOW)

Title: Clinical Research Support and Collaboration for NHGRI Protocols

BACKGROUND

The National Institutes of Health’s (NIH’s) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. The National Human Genome Research Institute (NHGRI), established in 1989, aims to improve the health of all humans through advances in genomics research. As a leading authority in the field of genomics, NHGRI’s mission is to accelerate scientific and medical breakthroughs that improve human health. This is achieved through driving cutting-edge research, developing new technologies, and studying the impact of genomics on society.
The NHGRI conducts a number of different types of research studies related to genetic conditions and the way that genes affect health, including natural history studies and therapeutic trials on rare diseases; statistical expertise has been found to be essential in determining the number of patients needed to discern a difference among groups, selecting an appropriate study design, and helping perform ongoing and final analyses. Conducting studies in the current and planned NHGRI protocol requires meticulous protocol monitoring, data management services, regulatory support of new and existing Investigational New Drugs (INDs) specializing in project oversight for vector management in order to remain compliant with established regulatory guidelines. Also essential is administrative assistance to run the Institute’s Data Safety and Monitoring Board (DSMB).

SCOPE

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; (3) analytical solutions, including bioinformatics, and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be capable of providing these services, as required under the individual task orders, to support NHGRI clinical research protocols and related activities within the scope of this IDIQ contract. The contractor should be capable assigning qualified personnel with experience in clinical trial design and regulatory