Solicitation: 36C25820R0041_1
The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) has a requirement to provide auditing Good Clinical Practice (GCP) services for the clinical trials conducted by the VA Cooperative Program (CSP).
This acquisition will be an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to acquire the services of experienced Contractors to serve as providers of clinical trial site auditing services.
The Contractor shall provide Clinical Research Quality Associate (CRQA) and provide services to the VA CSP through the Site Monitoring, Auditing and Resource Team (SMART) co-located with the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located in Albuquerque, New Mexico. The tasks include performing site visits, providing post-visit reports, and providing GCP quality assurance support.
The contractor shall conduct focused or specialized For Cause QA visits per the SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. These visits may require travel with less than 24-hour notice. In the case of For Cause visits the site is not notified of the visit. The contractor must be able to conduct these visits in the timeframe required by CSP Director or Program Leadership. The contractor may be required to lead a team of CSP staff that assist in conducting the site visit.
The contractor shall conduct focused or For Cause site visits per SMART SOPs to inspect VA investigators research study for compliance with GCP and with VA and CSP research policies. In conducting these sites visits, the contractor shall:
- Provide CSP Director and SMART leadership staff immediate feedback of significant discoveries made during site visits
- Assess site for key area/s of focused audit
- Assess site for key area/s of For Cause Audit
- Assess effectiveness of interactions between the investigator site study team and the contractor and other representatives of CSP
