Clinical Trial Management

This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. a. Background. 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. under Contract # N01-AI-30068, to continue performing Clinical Trials Management support specifically, as described below and in accordance with FAR 6.302-1. Under the current contract, PPD is providing support in the following areas: Clinical Site assessment, Site Monitoring, Study document preparation, pharmacovigilance, essential document collection, Good Clinical Practices (GCP) training, assistance to DMIS clinical sites in the establishment and/or enhancement of Internal Quality Control/Quality Assurance (QC/QA) programs, clinical trial tracking data management and web-based information dissemination. The DMID 03-154 study started in May 2005, and was completed in April 2008. The study was open during the period of time that requires reporting the results in the National Library of Medicine (NLM) ClinicalTrials.gov Protocol Registration System (PRS) for public view, as required by new federal regulations. This acquisition is to provide statistical and clinical data management support for the study results that will be reported in the ClinicalTrials.gov PRS. The reporting of the results is on a twelve-month extension and must be completed by April 1, 2010. The data are in DMID's custody; however the data are in raw database format without analyses. Therefore, the scope of this acquisition is to convert and analyze the data in the format required to be compliant with the ClinicalTrials.gov PRS. b. Project requirements. It is anticipated that this is a onetime action. The scope of the current project is to analyze the 03-154 raw data, and in compliance with the U.S. Public Law 110-85, format the data for reporting the results to the NLM ClinicalTrials.gov PRS website. The expectations of the contract-awardee are: 1. Review and analyze the 03-154 raw clinical data and available published reports 2. Format the data and analysis per NLM ClinicalTrials.gov PRS requirements. 3. Submit data tables and summaries to DMID for review and comment, 4. Submit the data tables and summaries to the PPD CTM Data group according to the most current process, 5. Resolve any subsequent queries from the NLM ClinicalTrials.gov. c. Anticipated period of performance. The estimated start date is August 15, 2009. The estimated date of completion is November 15, 2009. d. Other important considerations. This scope of work required that PPD provide de novo infrastructure development to support DMID's clinical research. To this end, PPD has assembled a well-trained staff of database programmers, web-designers, medical writers, clinical site monitors and other staff to support the diverse management needs. Of great significance is the cadre of database and systems programmers who have set up a tracking system for DMID's clinical protocols which allows for easy transfer of information to the National Library of Medicine's clinicaltrials.gov website. In the last year, the web designers have established a hub of resources utilized by over 450 password protected users worldwide. 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. Access to study related documents is granted to users on a role-restricted basis. PPD has also provided medical writers who are well versed in the various DMID protocol templates, and trained in writing, editing or reviewing protocols for DMID. 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, or any significant component thereof, were awarded to another contractor at this time, it would result in substantial duplication of costs to the Government (see below) that are not expected to be recovered through competition and unacceptable delays in fulfilling the agency's requirements on account of the interruption of numerous projects and inconsistency in oversight of the clinical research work conducted by DMID. e. Capability statement /information sought. 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 a capabilities statement that clearly demonstrate their ability to assume the work without necessary delay and duplication of cost and effort. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).