Contract Funds for Clinical Pharmacology Quality Assurance

Funding News Edition: January 21, 2021
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Can you provide comprehensive quality assessment for pharmacology labs that test samples from NIAID-supported clinical studies? Consider sending a proposal for NIAID’s reissued solicitation Clinical Pharmacology Quality Assurance (CPQA) Program.

In your proposal, describe your detailed work plan to accomplish the following:

  1. Monitor and evaluate the ability of labs to accurately and reliably perform study-specified pharmacology assays through an International Organization for Standardization (ISO)-certified proficiency testing program.
  2. Support the development, validation, and implementation of pharmacology assays.
  3. Acquire, characterize, store, and distribute to labs quality control materials and reagents.
  4. Provide guidance, assistance, and training to laboratory and clinical site staff in proficiency testing, assay validation, and conduct of clinical pharmacology studies.
  5. Prepare labs for FDA and other regulatory inspections and study audits.
  6. Maintain data management systems to track and manage CPQA activities.
  7. Publish and disseminate results to improve the quality of pharmacology measurements made in NIAID-supported clinical trials.
  8. Provide for initial and final transition of the contract.

NIAID expects to award a cost reimbursement, term/level of effort type contract to begin around February 28, 2022. The base period of performance is one year plus six one-year options to extend the term of the contract.

Be sure to check the solicitation for full details on requirements, the government’s options to extend the contract term and increase the level of effort, and more.

Your proposal is due on March 29, 2021, by 3 p.m. Eastern Time. Submit your proposal online through NIH’s electronic Contract Proposal Submission (eCPS) site.

Direct your questions to Shane Sarchiapone, the NIAID contract specialist for this opportunity.

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