This IDIQ acquisition seeks a contractor to provide comprehensive clinical research services for NHGRI protocols and related activities, including clinical research management, statistical design and analysis, protocol development, data management, clinical site management, pharmacovigilance, quality assurance, and regulatory affairs support. The contractor must also provide specialty services such as DSMB support, analytical solutions including bioinformatics, and integrated clinical trial management through an organized tracking system. Services will be required under individual task orders, and the contractor must assign qualified personnel experienced in clinical trial design and regulatory requirements. Relevant expertise includes rare diseases, genetic conditions, gene therapy including AAV9 vectors, and pediatric and adult populations as applicable to task orders.