SOURCES SOUGHT
A -- NIAID Clinical Research Products Management Center (CRPMC)
- Notice Date
- 2/16/2005
- Notice Type
- Sources Sought
- 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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-SS-NIH-NIAID-DAIDS-06-05
- Response Due
- 3/3/2005
- Archive Date
- 3/18/2005
- Description
- The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), plans, sponsors, and directs national and international extramural research programs testing vaccines, therapeutics, and preventive modalities. Through these programs, DAIDS supports more than 125 trials in over 40 countries at over 900 sites with 50,000 volunteers. DAIDS is seeking capability statements from organizations capable of providing a clinical research product management center to support the DAIDS? clinical research programs. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON CAPABILITIES RECEIVED FROM THIS SOURCES SOUGHT NOTICE THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The support to be provided under this contract will provide a central location to receive, store, repackage, label and distribute investigational agents used in clinical trials performed by DAIDS clinical trials networks and programs. The management of clinical products must be in accordance with Federal regulations governing investigational agents. The work to be performed under this contract is currently being carried out by McKesson BioServices under contract NO1-AI-85352. We are seeking to re-compete this contract. Work to be performed includes: 1) cognitive pharmaceutical services including: assessment of clinical protocols for pharmaceutical issues, evaluation of clinical protocols for quantities of pharmaceutical products, review of site pharmacy monitoring visits reports and charting of critical issues; provision of storage and stability information on pharmaceutical products; conference with the DAIDS Pharmaceutical Affairs Branch regarding pharmacy related protocol implementation issues; provision of assistance and training to research pharmacists in order to establish a quality assurance program; inspection of manufacturing facilities for current Good Manufacturing Practices; and evaluation of the appropriateness of requests for pharmaceutical products; 2) receipt and storage of study products; 3) labeling and packaging of study products; 4) development of validated shipping practices to protect the integrity of study products during shipment; 5) shipment and distribution of study products domestically and internationally; 6) ensuring that all shipping documents and permits are developed or obtained for international shipments; 7) provision of inventory control and quality assurance; 8) maintenance of an environment that is clean and sanitary and that meets current Good Manufacturing Practices criteria; 9) development and implementation of security and safety measures for the storage of study products; 10) provision of internal training with sufficient frequency to ensure all staff are trained in critical procedures 11) recall capability for study products from sites, and the process and disposal of returned drugs; 12) maintenance of a dedicated computerized tracking system for the range of product inventory services; and 13) purchase of a limited number of drugs as directed; 14) facilitation of an orderly transition to a subsequent contractor. For purposes of determining your related capabilities, you may assume: 1) the various networks and groups may have as many as 125 active studies at any given time and that the number of clinical sites will range from 1 to 250 per study, with as many as 700 of these sites located in South America, the Caribbean, Asia, and Africa; 2) an estimate that as many as 40 different study products per year will require repackaging 3) an estimate of 400 different products with 70,000 individual units requiring labeling. All capability statements will be evaluated against related ability and experience for providing pharmaceutical services: support for receipt, storage and inventory maintenance of domestic and international shipping of clinical trial study products; available qualified personnel; organizational background and experience; and documented availability of facility, equipment and other required resources to be dedicated to this project. It is anticipated that this contract will be for a 7-year period of performance and require an estimated 14 to 15 FTEs at the prime contractor site with expertise consistent with the operations of a project of this size and complexity. All interested organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Please respond as directed by Government-Wide Numbered Note 25: Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of pharmacists who may be assigned as a principal investigator; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration. A statement regarding compliance with Food and Drug Administration current Good Manufacturing Practice requirements should be included. Provide any other specific and pertinent information as pertains to this particular area of services provision that would enhance our consideration and evaluation of the information submitted. In addition, in accordance with Government-Wide Numbered Note 26: Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Record
- SN00752798-W 20050218/050217075942 (fbodaily.com)
- Source
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