Clinical Research Support and Collaboration for NHGRI Protocols

Description

The goal of this acquisition is to acquire 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 requirements, especially as relates to studies of rare diseases, genetic conditions, gene therapy (including via AAV9 vectors), and pediatric as well as adult populations, as applicable to individual task orders.

Classification

NAICS

541690

Other Scientific and Technical Consulting Services

54├Professional, Scientific, and Technical Services

541├Professional, Scientific, and Technical Services

5416├Management, Scientific, and Technical Consulting Services

54169├Other Scientific and Technical Consulting Services

541690└Other Scientific and Technical Consulting Services

PSC

R499

SUPPORT- PROFESSIONAL: OTHER

R├SUPPORT SVCS (PROF, ADMIN, MGMT)

R4├PROFESSIONAL SERVICES

R499└Other Professional Services

Set-aside

SBA

Total Small Business Set-Aside (FAR 19.5)

Description

Points of contact

Contracting office

Classification

Documents