Yia | Contract Alerts
Clinical Research Support and Collaboration for NHGRI Protocols
In plain English
National Human Genome Research Institute seeks a small business to provide clinical research support under an IDIQ contract, including trial management, statistics, data services and bioinformatics. Focus includes rare diseases and gene therapy studies.
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.
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