SPECIAL NOTICE
B -- Clinical Site Monitoring of the CDC Safety and Efficacy Trails for Truvada in Botswana and Tenofovir in Thailand
- Notice Date
- 5/23/2007
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 42266
- Response Due
- 6/6/2007
- Archive Date
- 6/21/2007
- Description
- In accordance with 41 U.S.C. 253(c)(1) and FAR 6.302(1), the Centers for Disease Control and Prevention (CDC) intends to issue a sole-source, cost-plus-fixed fee modification under contract 200-2005-13112 to the incumbenant contractor, Pharmaceutical Product Development (PPD) in Wilmington, NC. The original requirement was competed in July 2005 and awarded to PPD. For continuity and consistency of the research projects, monitoring and training, it is imperative that PPD continue to provide the required services. PPD has the unique capability and specialized experience to perform and complete the existing monitoring services in a timely and scientifically sound manner. Utilizing another contractor at this juncture, would render the work performed to date scientifically questionable and it would impede the successful completion of the research being conducted. The government will experience tremendous cost savings if PPD continues to perform under this contract. The trials will not have to end pre-maturely and start up costs will not be incurred. The original contract consisted of: Phases I. Task 1. Study and Protocol Planning Task 2. Regulatory Activities Task 3. Site Monitoring and Management Task 4. Site Staff Training Task 5. Project Management and Team Training Phase II. Task 1. Study and Protocol Planning Task 2. Regulatory Activities Task 3. Site Monitoring and Management Task 4. Site Staff Training Task 5. Project Management and Team Training Phase III. Task 1. Regulatory Activities Task 2. Site Monitoring and Mangement Task 3. Site Staff Training Task 4. Project Management and Team Training At the conclusion of the Phase I, Phases II and III were revised and incorporated into the existing contract as modification one. Since 2005 CDC has funded BOTUSA, collaboration between the Government of Botswana, TUC, Thailand and CDC, to conduct safety and efficiency trials to determine whether ART taken as PrEP is safe on a long-term basis and whether it reduces the rate of acquisition of HIV infection. In Botswana, the trial is being conducted among heterosexually active young adult men and women in Gaborone and Francistown. In Thailand, the trial is enrolling injection drug users at 17 drug treatment clinics in Bangkok. The agent chosen for the study in Thailand is Tenofovir Disoproxil Fumarate (TDF). The Thailand study will increase the cohort size by 400 participants and extend the timeframe for participation in the study. TDF was the agent initially chosen for the study in Botswana. However, six months into the study the decision was made to change the study drug to Truvada? which is a combination of TDF and emtricitabine (FTC). Participants in both studies are randomized to receive either study drug or its placebo and are followed for any adverse effects of the agent, any changes in their sexual or injection drug risk behavior, and HIV incidence. Results of this study will determine whether TDF or Truvada? is safe and effective as long-term prophylaxis against HIV infection among those exposed sexually or by injection drug use, in addition to standard risk reduction methods. The Contractor shall furnish all personnel, facilities, supplies, materials, equipment, transportation, and travel necessary to carry out the follow up of the AIDSVAX? B/E vaccine trial cohort. The existing contract will be modified to incorporate the research activity revisions for Phase III and to add an additional Phase IV. These revisions will extend the monitoring and training components of the existing contract by sixteen months (16) months. Phase III Task 1. Regulatory Activities A. The contractor shall review the investigator regulatory document packages for the CDC-funded sites (Form 1572, etc.) and provide advice to the sites on the completeness and accuracy of the packages. CDC will track and obtain annual Internal Review Board (IRB) renewals at the sites and CDC. B. The contractor shall periodically review original documents pertaining to site and data management in a Trial Master File (maintained by each CDC-funded site) according to the Food and Drug Administration (FDA) requirements for retention of study-related documents. Task 2. Site Monitoring and Management A. The contractor will conduct monthly ongoing monitoring visits at each investigative site to successfully monitor the conduct of these trials. In cooperation with CDC, the contractor will adjust this interval according to clinical site accrual, site performance, adherence to the protocol, and data quality. Each ongoing monitoring visit is assumed to take 2-3 days total for preparation, travel, on site activities, and report writing. The interim monitoring visits shall include: Review of subject records and case report forms for accuracy and completeness of information/data, compatibility with source documents and investigator review/signature. Continuous evaluation of data received regarding the safety and efficacy of the test drug, taking appropriate action, as indicated by any pertinent federal or state law and regulation, or as requested by CDC. Periodic review of regulatory documentation (including CVs, Form FDA 1572, IRB approvals, safety reporting, drug accountability, etc.), and documenting deficiencies, assisting in the follow-up/corrections with the clinical site staff, and collecting updated or revised regulatory documentation. Monthly inventory of OraQuick test kits at each site. B. The contractor will: Verbally report any significant findings to CDC with 24 hours following the monitoring visit. Complete and deliver to CDC, within 10 working days of the monitoring visit, a written visit report, following the specification of CDC?s Standard Operational Procedures (SOPs or the contractor?s SOPs if deemed appropriate by CDC and documented). The report will include, but not be limited to: screening, eligibility, and enrollment accrual, visit compliance; safety issues identified (e.g., Serious Adverse Events (SAE) reports), consent form and CRF completion; data entry and management compliance, laboratory quality control/quality assurance (QC/QA) results, status of regulatory documents, drug accountability, summary report on OraQuick test kit inventory, etc. The report will include a summary of the pertinent points from each visit and any recommended or agreed upon actions. C. The contractor will maintain monthly telephone contacts with study sites throughout the trials and generate brief telephone reports of verbal c correspondence with sites to monitor for compliance with study procedures. D. The contractor will conduct closeout visits at each of the two sites. Each closeout visit is assumed to take 3-4 days for preparation, travel, on- site activities and report writing. Task 3. Site Staff Training A. The contractor shall provide GCP-related training to site staff as indicated by results of monitoring visits. For purposes of planning, five days of training with two trainers should be budgeted per year at each of the two trial sites. Training slides will be translated to Thai for the GCP training in Thailand. Contractor shall provide venue for training in Thailand. Task 4. Project Management and Team Training A. The contractor shall assign a single project manager for each CDC- funded site (Botswana and Thailand) to serve as a main point of contact for discussion of program-related issues. B. The contractor shall generate quarterly written project status reports for each CDC-funded site in a mutually agreed-upon format. C. The contractor shall be responsible for providing program-specific training to contractor personnel assigned to the study. It is expected that personnel assigned to these studies at each site (Botswana and Thailand) will continue to work on this project until its completion. If personnel change due to unforeseen circumstances, the contractor shall assume the cost of training new staff. Phase IV Task 1. Regulatory Activities A. The contractor shall review the investigator regulatory document packages for the CDC-funded sites (Form 1572, etc.) and provide advice to the sites on the completeness and accuracy of the packages. . CDC will track and obtain annual Internal Review Board (IRB) renewals at the sites and CDC. B. The contractor shall periodically review original documents pertaining to site and data management in a Trial Master File (maintained by each CDC-funded site) according to the Food and Drug Administration (FDA) requirements for retention of study-related documents. Task 2. Site Monitoring and Management A. The contractor will conduct monthly ongoing monitoring visits at each investigative site in Botswana to successfully monitor the conduct of these trials. In cooperation with CDC, the contractor will adjust this interval according to clinical site accrual, site performance, adherence to the protocol, and data quality. Each ongoing monitoring visit is assumed to take 2-3 days total for preparation, travel, on site activities, and report writing. The interim monitoring visits shall include: Review of subject records and case report forms for accuracy and completeness of information/data, compatibility with source documents and investigator review/signature. Continuous evaluation of data received regarding the safety and efficacy of the test drug, taking appropriate action, as indicated by any pertinent federal or state law and regulation, or as requested by CDC. Periodic review of regulatory documentation (including CVs, Form FDA 1572, IRB approvals, safety reporting, drug accountability, etc.), and documenting deficiencies, assisting in the follow-up/corrections with the clinical site staff, and collecting updated or revised regulatory documentation. Monthly inventory of OraQuick test kits at each site. B. The contractor will: Verbally report any significant findings to CDC with 24 hours following the monitoring visit. Complete and deliver to CDC, within 10 working days of the monitoring visit, a written visit report, following the specification of CDC?s Standard Operational Procedures (SOPs or the contractor?s SOPs if deemed appropriate by CDC and documented). The report will include, but not be limited to: screening, eligibility, and enrollment accrual, visit compliance; safety issues identified (e.g., Serious Adverse Events (SAE) reports), consent form and CRF completion; data entry and management compliance, laboratory quality control/quality assurance (QC/QA) results, status of regulatory documents, drug accountability, summary report on OraQuick test kit inventory, etc. The report will include a summary of the pertinent points from each visit and any recommended or agreed upon actions. C. The contractor will maintain monthly telephone contacts with study sites throughout the trials and generate brief telephone reports of verbal correspondence with sites to monitor for compliance with study procedures. D. The contractor will conduct closeout visits at each of the two sites. Each closeout visit is assumed to take 3-4 days for preparation, travel, on- site activities and report writing. Task 3. Site Staff Training A. The contractor shall provide GCP-related training to site staff as indicated by results of monitoring visits. For purposes of planning, five days of training with two trainers should be budgeted per year at each of the two trial sites. Task 4. Project Management and Team Training A. The contractor shall assign a single project manager to serve as a main point of contact for discussion of program-related issues. B. The contractor shall generate quarterly written project status reports in a mutually agreed-upon format. C. The contractor shall be responsible for providing program-specific training to contractor personnel assigned to the study. It is expected that personnel assigned to the study in Botswana will continue to work on this project until its completion. If personnel change due to unforeseen circumstances, the contractor shall assume the cost of training new staff. Interested parties who feel that they possess the capabilities to provide the services described above should submit a capability statement demonstrating their abilities to provide the services. The information received in response to this notice will be considered solely for the purpose of determining whether or not to conduct a competitive procurement. Please send your documentation to Zalerie Moore at the office identified above, by fax (770) 488-2688 or email to fkw@cdc.gov. Documentation should be received within fifteen (15) days after the date of publication of this synopsis to be considered by CDC. A determination by the CDC not to compete this proposed contract based upon responses to this notice is solely within discretion on of the government
- Place of Performance
- Address: Thailand and Botswana.
- Country: BOTSWANA
- Country: BOTSWANA
- Record
- SN01301153-W 20070525/070523220607 (fbodaily.com)
- Source
-
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