SPECIAL NOTICE
A -- Clinical Site Monitoring Project
- Notice Date
- 7/11/2006
- Notice Type
- Special Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-JOFOCSYNOPSISN01AI05405
- Response Due
- 8/25/2006
- Archive Date
- 9/9/2006
- Description
- The Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), intends to extend the current contract N01-AI-05405 with Pharmaceutical Product Development (PPD) for 36 months until December 31, 2009 under Authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(b)(1)(i), Unique Capabilities. The Clinical Site Monitoring Project is designed to meet the needs of NIAID by conducting on-site monitoring, Good Clinical Practice (GCP) Training, and quality management consultation for the following networks or major study sites of the Adult AIDS Clinical Trials Group (AACTG), the Pediatric AIDS Clinical Trials Group (PACTG), the Acute Infection Early Disease Research Program (AIEDRP), the Community Programs for Clinical Research on AIDS (CPCRA), the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the NIAID Vaccine Research Center (VRC), the ESPRIT and SMART studies, the Comprehensive International Program for Research on AIDS (CIPRA) and a host of other investigator initiated non-network based clinical trials. The NIAID, as the funding agency for trials conducted by these groups, must provide oversight under Title 45 CFR 46, and when DAIDS holds the Investigational New Drug (IND) application Title 21 CFR 50 & 56 which deals with the protection of human subjects in research. The current contractor monitors or audits in 50 countries, at 900 sites on over 300 active protocols. Their primary role is to help DAIDS ensure that the rights and well-being of trial participants are protected and that the data collected during the course of a study is complete and accurate. They do this by monitoring adherence to the protocols, the reporting of adverse experiences, and by conducting audits of the regulatory files and pharmacies. Several types of assessment visits may be conducted including site initiation, interim site visits, closeout visits, quality management consultation visits and special assignment visits. Additionally, sites may request GCP training, source document and essential document training, and may choose from several other training modules that can be tailored to meet the specific needs of the trial sites. Currently, PPD conducts monitoring in more than 50 countries at over 900 clinical trial sites on more than 300 protocols. With more than 40 offices worldwide they have been able to quickly move into even the most remote areas. Additionally, on-site monitoring of NIAID sponsored studies is both a regulatory responsibility as well as a moral obligation in order to ensure that the safety and well being of study subjects is protected. PPD currently has a highly experienced staff of well-trained monitors already working in or able to travel to the designated countries and are well positioned to begin additional monitoring as needed. There is already a fully validated system in place for collecting, verifying and reporting of monitoring results by site. Management systems are in place for frequent conference calls for the program officers responsible for each of the networks to discuss on-going issues related to the monitoring effort. PPD has many years experience in monitoring these DAIDS funded networks and can immediately expand their work on this project to accomplish unique monitoring tasks as they arise. As more and more sites are added we continue to have an urgent need for on-going training on evolving DAIDS policies and procedures, Good Clinical Practice, Federal Regulations, and Human Subjects Protections. Adequate training in all aspects of clinical trials research is the key to ensuring consistency in results from multiple sites around the globe. PPD has provided these training activities as needed in resource limited environments and has worked with DAIDS staff to develop a ?train the trainer? program to address on-going and future needs. In summary, DAIDS recognizes that the PPD monitoring and training group has the unique capabilities to immediately implement the necessary activities at new sites without unacceptable delays. Additionally, with on-going studies at more than 900 sites there is a need for continuous monitoring and training activities. PPD is currently the only monitoring/training contractor to perform these services for the DAIDS funded networks listed above and they can continue this activity without any lost time or negative impact to the on-going trials. To introduce a new contractor for this period of time to perform these substantial and critical activities could jeopardize the safety of clinical trial participants and delay the success of new treatments and interventions for the prevention of HIV/AIDS. It would not be in the best interest of NIAID/DAIDS to interrupt or delay monitoring and training in these challenging environments in the developing world. In addition, solicitation and negotiation with a new source would take approximately 18 months or more and would result in unacceptable delays in ongoing NIAID research efforts. It is estimated that a new contractor would result in a duplication of funds for start-up, hiring, training, development and validation of the necessary albeit temporary monitoring database, SOP generation and approval, and other systems requirements. The costs associated with these and other various start-up activities would be in excess of $1,000,000, would not be recovered through competition and would result in a significant and unacceptable delay in required activities. Additionally, this extension would allow time for the completion of the restructuring of the DAIDS funded networks and awarding of the new grants for clinical trial sites. It would also allow sufficient time for completion of the requirements for the interface with the DAIDS ES. In turn, this would permit the development of a more complete and accurate Scope of Work for the next re-competition of the monitoring contract which would allow a more level playing field for offerors. Therefore, no other service will satisfy Agency requirements. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting their interest and a capability statement demonstrating their ability to assume the work without unnecessary delay and duplication of costs and effort. See Government-Wide Numbered Notes 22 and 26.
- Place of Performance
- Address: 3151 South 17th Street, Wilmington, North Carolina
- Zip Code: 28412
- Country: UNITED STATES
- Zip Code: 28412
- Record
- SN01086281-W 20060713/060711220335 (fbodaily.com)
- Source
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