NIAID Clinical Pharmacology Quality Assurance Program

Sponsor Deadline: 

Mar 29, 2021


NIH National Institute of Allergy and Infectious Diseases

UI Contact: 

NIAID Clinical Pharmacology Quality Assurance Program
Notice ID  75N93021R00003  contract opportunity

The purpose of the proposed contract will be to continue to provide a Clinical Pharmacology Quality Assurance Program resource to provide comprehensive quality assessment programs to clinical pharmacology laboratories (Labs) that test samples from subjects enrolled in NIAID-supported clinical studies.  The Contractor shall:  (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 in the conduct of clinical pharmacology studies; (5) prepare Labs for FDA and other regulatory inspections and study audits; (6) maintain data management systems for tracking and managing CPQA activities; (7) publish and disseminate results, to improve the quality of pharmacology measurements made in NIAID supported clinical trials; and (8) provide for initial and final transition of the contract.  Options to provide increased level of effort to support additional labs (domestic and international) and to support unanticipated increases in demand for the activities supported by the base requirements of the contract, are also within the scope of the contract.