Clinical Pharmacology Quality Assurance Program

Added: Mar 06, 2014 9:23 am Please see attachment for RFP/Solicitation.

Added: Feb 20, 2014 11:56 am The mission of the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is to help ensure an end to the HIV/AIDS epidemic by increasing basic knowledge of the pathogenesis and transmission of HIV, supporting the discovery and development of therapies for HIV infection and its complications, and supporting the discovery and development of vaccines and other prevention strategies.

The purpose of the NIAID Clinical Pharmacology Quality Assurance (CPQA) program is to provide a comprehensive quality assessment program for clinical pharmacologic laboratories testing samples from subjects enrolled in NIAID-supported clinical studies. The CPQA program ensures the validity and inter- and intra-laboratory comparability of pharmacological study data by providing laboratories with materials for pharmacology proficiency testing and assay controls, and monitoring proficiency and assay data from each laboratory. The program also implements standards of performance for new pharmacology assays, develops and tests methods relating to the assays, and acquires, tests, stores and dispenses quality control materials and reagents. Thus, the CPQA program is critical to the scientific integrity of on-going and future studies concerning assessment of anti-HIV treatments and preventive measures.

The purpose of the proposed contract will be to continue to provide a comprehensive quality assurance program, and the Contractor shall provide support to: (1) evaluate the ability of Labs to accurately and reliably perform study-specified pharmacology assays; (2) provide for the planning and execution of single and multi-Lab studies for the development, validation and implementation of bioanalytical methods for measuring drug concentrations in study specimens; (3) acquire, characterize, store, and distribute to Labs quality control materials and reagents; (4) provide guidance and assistance to Lab and clinical site staff in proficiency testing, assay validation and in the conduct of clinical pharmacology studies; (5) prepare Labs for FDA inspections and study audits; and (6) host and maintain computerized systems to track CPQA Program activities. CPQA will continue to support laboratories that are part of current and future NIAID-sponsored clinical trial networks (http://www.niaid.nih.gov/about/organization/daids/networks/pages/daidsnetworks.aspx).

It is anticipated that one (1) cost-reimbursement, level-of-effort (term) type contact will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about March 1, 2015. The requirement will be for the delivery of 8.85 full time equivalents (FTEs) per year for the Base Period (Year 1) each option period (Years 2 through 7).

In addition, the Government may unilaterally exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include:

Increased Level of Effort for Additional US and non-U.S. pharmacology laboratories: During the course of the contract it may be necessary to incorporate additional laboratories to support new NIAID-supported clinical trials. Such an increase would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each Option of this type will implement work commensurate with the addition of one domestic or international Lab. If the Government elects to exercise this Option, the Contractor shall provide 0.9 FTEs per option. Up to two options per year may be exercised during years 2 through 7 of contract performance.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about March 6, 2014, and may be accessed through FedBizOpps at http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.