A -- DMID Clinical Trial Management

The Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) intends to negotiate on a sole source basis with PPD Development, Inc., to continue performing Clinical Trials Management support for an additional two years, as set forth in FAR 6.302-1. The proposed award represents a continuation of work originally awarded in 2003 to PPD Development Inc., under Contract N01-AI-30068. Under the current contract, PPD is providing support in the following areas: protocol writing, development and review; pharmacovigilance and safety oversight; clinical site monitoring and site assessment; quality management and third party audits; GCP training for DMID program staff and funded investigators; information management services and web site development and support; meeting planning and support; and a subcontract for H5 avian flu laboratory assays. The scope of work required that PPD provide infrastructure development to support DMID?s clinical research. PPD developed this infrastructure de novo, specifically the customization of a clinical trials management tracking database, development of a centralized pharmacovigilance and safety oversight systems. This customized database is critical to DMID?s ability to track the status of over 400 protocols worldwide and the data transfer of over 125 protocols to the National Library of Medicine's ClinicalTrials.gov registry. The development of this infrastructure required more time and effort than originally anticipated. Interruption to these activities would have a significant impact on DMID's ability to meet the urgent demands of the pandemic H5 avian flu clinical research, as well as other Category A, B and C priority pathogen clinical research support. In addition, since the time of the award, the volume of clinical research performed by DMID has increased significantly due to growing biodefense efforts (e.g., smallpox, anthrax, and tularemia) and the urgency to perform pandemic and seasonal influenza vaccine research. At the time of award, it was not anticipated that PPD would be providing support to such a high volume of high visibility clinical trials conducted with the intent for FDA licensure. As a result, the amount of work increased dramatically due to the increased intensity of support required for these trials. Therefore, DMID has determined PPD is the only responsible source to provide the complex and integrated support services to meet DMID clinical research demands at this time. If the clinical trials management support contract were awarded to another contractor at this time, it would result in substantial duplication of cost to the Government and unacceptable delays in fulfilling the agency's requirements on account of the vast interruption and inconsistency in oversight of the clinical research work conducted by DMID. Therefore, no other service will satisfy DMID's requirements. If there are responsible sources who feel that they are able to perform the requirement, they must respond by submitting the information required by Numbered Note 22 on/before the closing date noted in this announcement. Organizations that submit capability statements in response to this announcement must demonstrate their ability to assume the work without unnecessary delay and duplication of cost and effort. You are directed to Government-Wide Numbered Notes 22 and 26. No collect calls will be accepted.