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CSP AUDITING SVCS


Arizona, United States
Government : Federal
RFI
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The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), located in Albuquerque, New Mexico, provides Good Clinical Practice (GCP) Quality Assurance Services (QAS) for the clinical drug trials conducted by the VA Cooperative Studies Program (CSP). These trials are conducted at VA facilities and associated non-VA facilities throughout the United States, Canada, and the United Kingdom. The clinical trials of the CSP vary over time in number, size and design, but typically consist of 25 trials conducted at 300 to 400 investigative sites.

The CSP requires "nonpersonal" services to serve as the key provider of GCP services and guidance for program development and maintenance. The contractor shall provide these services to the CSP through a division of the CSPCRPCC called SMART (Site Monitoring, Auditing and Resource Team) located at 2401 Centre Ave., Albuquerque, New Mexico 87106-4180. Base of operation is the CSP office in Albuquerque, NM; position requires up to 50% within US travel, and no overseas travel.


CONTRACTOR'S RESPONSIBILITIES:

a.    The Contractor will Manage, Direct and Oversee the GCP Clinical Quality Assurance Program for CSP Trials

"    Oversee or serve as the Sponsor's Designated Representative for the review of reports received from site inspectors
"    Serve as the trainer and mentor for the site inspectors assigned to the trial
"    Provide guidance and direction to site inspectors before, during and after the site visits
"    Compile and analyze inspection findings, assessing strengths and deficiencies in research practices of investigators and of the VA Research facilities
"    Provide feedback to the CSP on trends and findings noted in site inspector's reports, both individual trials and across all CSP trials, noting the appropriate application of CSP and VA policies and procedures and the need for new or revised program policies
"    Prepare, conduct and/or oversee the CSP pre-FDA Inspection Program

a.    Provide Support for Program and Policy Development within CSP

"    Review the SMART, CSP and VHA policy and procedures on research and advise SMART and CSP on necessary changes; revise and develop 'GCP-consistent' Standard Operating Procedures (SOPs) for SMART and the CSP as necessary. The SOPs shall reflect an integrated program for site monitoring, site auditing and centralized monitoring of study conduct by the Investigator and Sponsor.
"    Develop and maintain a Basic Monitoring Plan Template to be adapted to and implemented in all ongoing CSP trials (procedures, forms, report formats, etc.)
"    Develop and maintain a prototype Site Auditing plan to be adapted to and implemented in ongoing and future CSP trials (procedures, forms, report formats, etc.)
"    Oversee revision and expansion of the SMART GCP classroom-style course as necessary to provide specialized versions applicable to specific audiences, e.g., investigators, CSP personnel and non-CSP research personnel VA-wide
"    Develop packets of guidance and tools to aid Investigator and Sponsor sites in preparing for FDA inspection or other inspections for GCP compliance

a.    Direct and Oversee Clinical Quality Assurance Site Inspections (Site and Sponsor)

"    Ensure that the site visits conducted by SMART to inspect VA investigators for compliance with GCP, VA and CSP research policies and SMART SOP are performed in accordance with the following publications:
o    VHA Handbook 1200.5
o    45 CRF 46 - Protection of human subjects
o    38 CFR 16 (VA Common Rule) - Protection of Human Subjects
o    E6 - ICH Guidelines - May 2007
o    SOP-SMART:
"    100 - General Management - 9/13/07
"    200 - Study Support Planning and Startup - 9/13/07
"    210 - Good Clinical Practices Training Preparation - 9/13/07
"    220 - Pre-Kickoff Tools and EDB Preparation - 9/13/07
"    310 - Site Visit Tools Development and Training - 10/04/07
"    500 - SMART Auditing - 2/25/08
"    510 - SMART Conduct of For-Cause Audits - 2/25/08
"    520 - SMART Conduct of Sponsor Audits - 2/25/08
"    530 - SMART Conduct of Routine Site Audits - 2/25/08
"    531 - SMART Routine Audit Report Review and Distribution - 2/25/08
"    532 - SMART Audit Report Follow-up and Resolution - 2/25/08
"    Ensure that individuals serving as SMART site visitors:
o    Audit subject and investigator records for compliance with GCP and VA policy
o    Know and comply with VA Privacy Policy for the duration of the contract.
o    Provide immediate feedback on findings to VA CSP research management
o    Provide guidance during visit on study conduct and use of GCP tools to improve study site practices
o    Prepare reports for distribution after each inspection citing OFIs (opportunities for improvement) and providing recommendations for correcting problems and improving practices
o    Conduct periodic site visits per SMART SOPs to inspect offices of CSP Management (Sponsor) for compliance with GCP and with VA and CSP research policy
o    Assess effectiveness of interactions between the investigator site study team and the monitor and other representatives of CSP
"    Serve as or oversee the actions of the Sponsor's Designated Representative for the review of reports received from the SMART site visitors.

a.    Trending of Site Visit Findings for CSP/Quality Improvement

"    Review findings of all site visits assigning a deficiency category for each finding
"    Prepare findings and trends for presentation at study and CSP annual meetings
"    Provide recommendations concerning retraining specific to findings and trends

a.    Direct and Oversee GCP Training Program for VA Researchers and CSP Site Monitors

"    Perform or oversee the following tasks:
o    Maintain and periodically present a classroom style GCP course to VA researchers throughout the country
o    Present the course to researchers using SMART's PowerPoint-based Audience Response Voting System which is routinely employed for these presentations
o    Provide updates as needed to keep course content current with respect to GCP and current industry standards
o    Serve as primary contact for follow-up activities for the training course, i.e., serve as the resource expert for the attendees
o    Maintain and update a GCP monitor training program for the site monitors of CSP trials. Individualized modules will be needed specific for monitor trainees within CSP and for non-VA contract monitors as may be used for CSP trials

a.    Oversee the Development of tools, worksheets and GCP guidance for each new CSP trial

"    Design systems for organizing patient files at investigative sites
"    Develop requirements, procedures and guidance for source documentation of key study data within each trial incorporating use of VA Computerized Patient Record System (CPRS)

OPERATIONAL TIME REQUIREMENTS: The contract services shall be operable and available for use 100% of the time, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (MST).


The North American Industry Classification System (NAICS) is 541611, Administrative Management and General Management Consulting Services. Any firms who wish to identify their interest and capability to provide the above listed services must provide written notice to the undersigned Contracting Officer no later than 5:00 P.M. EST, 7/28/2014. Such notification must include:
"    Documentation which shall contain credentials and certifications, both personnel and corporate, along with descriptions of how the firm will meet or exceed the Government's needs;
"    List of government or non-government contracts (to include awarding agency) awarded over the last 3 years, for similar and relevant services;
"    Contractor's socio-economic status, as certified in SAM, VetBiz, SBA and other federal sites (e.g. Small Business, Service-disabled Veteran-owned Small Business, Large Business ).

Notification shall be e-mailed or faxed to Enrique Rivera, Contracting Officer, (480) 361-9460 / enrique.rivera@va.gov. Upon receipt of any such notification, the Contracting Officer will determine whether to conduct a set-aside or unrestricted competitive procurement or proceed with a sole source acquisition.

Responses received will be evaluated; however, a determination by the Government not to compete this proposed procurement based upon responses to this notice is solely within the discretion of the Government.

THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS OR QUOTES.



DISCLAIMER
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

ENRIQUE J. RIVERA
480-466-7921
enrique.rivera@va.gov

ENRIQUE.RIVERA@VA.GOV

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