and Human Services (HHS)
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 [email protected]
Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288,
Fax 301-480-5253, Email [email protected]
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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