This Government Contract opportunity from Department Of Health And Human Services was posted on June 27, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Drug Development Support for the Cancer Therapy Evaluation Program
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The National Cancer Institute's Cancer Therapy Evaluation Program (CTEP), under the Division of Cancer Treatment and Diagnosis, is seeking a contractor to provide comprehensive drug development support to fulfill its role as a clinical trial sponsor. This effort supports an extensive extramural clinical oncology program involving approximately 195 active Investigational New Drug Applications and 400 clinical studies, ranging from pilot to licensing trials. The scope of work requires expertise in investigational drugs, biologics, and assays to navigate regulations across various FDA offices, including CDER, CBER, and CDRH. The selected contractor will be responsible for the preparation, tracking, submission, and distribution of FDA submissions, including the operation of eCTD software. Key duties include monitoring and supporting adverse event reporting through helpdesk services, tracking investigational anti-cancer agents, and providing general administrative and technical support for regulatory activities. Additionally, the contractor must implement a Quality Control Program to ensure compliance with evolving health agency regulations and NIH and HHS policies. This requirement follows previous services performed by Technical Resources International, Inc. under NAICS code 541715.
General Info
Contract Value
$39,320,905Place of Performance
Rockville, MD, 20850, USASet-Aside
Award Issued Date
Documents
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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