RFP ANNOUNCEMENT: HIV CLINICAL RESEARCH MANAGEMENT SUPPORT CENTER - RFP-NIH-NIAID-DAIDS-05-06 RELEASE DATE: June 17, 2004 NOTICE: NOT-AI-04-037 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) RECEIPT DATE: September 17, 2004 DESCRIPTION The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking organizations with clinical and technical expertise and facilities to advance the Division of AIDS (DAIDS) clinical research mission through the provision of flexible research management support services and activities at multiple levels to facilitate a complex and rapidly evolving global research agenda. This project is being solicited under full-and-open competition under NAICS 541710 but this decision may be subject to change following the final review by the NIH Small Business Officer. A Pre-Proposal Conference will be held to provide potential offerors an opportunity to participate in a discussion of the requirements identified in this RFP. The date for the pre-proposal conference will be listed in the solicitation. The DAIDS is seeking a contractor to provide a set of Core Functions that will constitute a comprehensive Centralized Clinical Research Program Management Center to support multiple Phase I, II and III HIV clinical research efforts. The functions designated as Core in the SOW provide critical oversight and management of clinical trial operations that are vital to the DAIDS mission and include centralized clinical research program management subcontract acquisition and management, and contract transition. Therefore, only offerors that propose to perform the functions designated as Core Functions within their own organization (not subcontracted out) will be considered for Technical Evaluation. A second component of the proposed contract is comprised of a set of Non-Core Functions that are highly specialized activities, with the emphasis being on the contractor’s ability to provide rapid response to requests to perform these Non-Core Functions either through subcontracts or assuming the additional work in-house for a variety of support to the Division of AIDS Network and non-Network activities. It is important to note that these Non-Core Functions cannot be quantified at this time but rather can only be defined as a general set of clinical trials management activities that will be needed as the DAIDS portfolio evolves and the DAIDS product-development cycle continues. All offerors responding to this solicitation will be provided with a uniform dollar assumption for the anticipated costs of subcontracting activities for Non-Core Functions. All offerors will be directed to NOT provide any names or specific information regarding future subcontracting activities. This critical contract will reside within a complex research environment and will require that the contractor work with a consortium of multiple clinical trial groups and DAIDS contractors. The work will be primarily international in scope and conducted in developing countries. Specific functions performed within this contract will vary and will be trial-specific. The contractor must have the capacity and capability to work with DAIDS-specified grantees and contractors and must possess the ability and relevant scientific expertise to establish necessary linkages (administrative, logistical, operational, information technology, etc.) as required for sound research program management and clinical trials management. Major Core Functions will include centralized clinical research program management, subcontract acquisition and management, and contract transition. Major Non-Core Functions will include site management activities to include: site identification/assessment activities (preparation, coordination, evaluation, financial management, staff recruitment, equipment and facilities management, and on-the-ground oversight); clinical trials management activities [data management, DSMB support, biostatistical support, laboratory and specialized studies support, medical writing and document generation, shipping, pharmacy support, communication support, volunteer recruitment and retention, and volunteer counseling and clinical trials compliance activities (training, regulatory activities, monitoring, quality assurance, safety monitoring]. The prime contractor must have the ability to sub-contract with a variety of expert vendors and manage those contracts. Offerors will be evaluated on: experience in global research program management, subcontracting acquisition and management, and ability to provide support in the form of a wide variety of tasks associated with Phase I, II and III clinical trials. Past experience in conducting complex programs and partnering with multiple entities to provide support for a clinical trial and infrastructure development and staffing, ability to obtain and provide on- the-ground staff and expertise in the conduct of clinical research in resource-constrained areas such as Southeast Asia, Africa, Eastern Europe; experience in similar projects with special emphasis on the ability to anticipate special conditions likely encountered among resource-constrained sites in developing countries; experience in working with the political and diplomatic demands of research management in international settings; ability to provide expert subcontracts for all facets of clinical trials and clinical research management; provision of IT support and infrastructure development for IT capacity in resource-constrained countries; experience in managing large complex clinical research programs and a large complement of subcontracts; location of management core of key personnel in the Washington, D.C. area; and willingness to partner with Contract Research Organizations (CROs), Site Management Organizations (SMOs), Federal entities, pharmaceutical companies, and Non-Governmental Organizations (NGOs). This is a new effort; there is no incumbent. This new contract will be awarded as a cost-reimbursement, incrementally-funded type contract. It is anticipated that the period of performance for this contract will be a total of five years with an estimated level-of-effort of 150,400 total labor hours per year (approximately 80 FTEs) with an unknown quantity of subcontracts at this time. RFP-NIH-NIAID-DAIDS-05-06 will be available electronically on the CMP Homepage on or about June 17, 2004, http://www.niaid.nih.gov/contract/default.htm and will be posted in the FedBizOpps, http://www.fedbizopps.gov/. Only electronic copies of the solicitation will be available. All information required for the submission of an offer will be contained in the solicitation. Responses to this RFP will be due September 17, 2004. Any responsible offeror may submit a proposal that will be considered by the Government. This announcement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. CONTRACTING OFFICE ADDRESS Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases Division of Extramural Activities Contract Management Program 6700-B Rockledge Drive Room 3214, MSC 7612 Bethesda, MD 20892-7605 POINT OF CONTACT Elizabeth Shanahan, Contract Specialist, Phone 301-594-6309, Fax 301-480-5253, Email es219j@nih.gov Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253, Email bs92y@nih.gov

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