The Division of Allergy, Immunology and Transplantation (DAIT), 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 in basic immunology, asthma and allergic and immunologic diseases. Through these programs, DAIT-supported investigators conduct basic, pre-clinical and clinical investigations into the causes, diagnosis, prevention and treatment of a broad range of immune-mediated disorders. DAIT is seeking capability statements from organizations capable of performing clinical site monitoring services in support of DAIT's Immune Tolerance Network (ITN). 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 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 contractor will establish a Clinical Site Monitoring Group (CSMG) to assess the quality and enhance performance of sites participating in the Immune Tolerance Network (ITN). In FY 1999, the NIAID established the Immune Tolerance Network (see http://www.immunetolerance.org) an international consortium of over 70 basic scientists and clinical investigators, to test promising tolerogenic treatment regimens in four clinical areas: islet transplantation; kidney transplantation; autoimmune diseases; and asthma and allergic diseases. In FY 2000, the ITN began accepting proposals for clinical trials of tolerance induction and has completed 14 full review cycles by July 2002. A total of 155 concept proposals have been submitted and 46 were accepted for submission as full proposals; non-ITN members submitted approximately 75% of these. To date, 21 clinical trials have been approved for implementation in all four clinical areas. The ITN is co-sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Research Foundational International (JDRF). This contract will be managed by the DAIT Office of Clinical Applications which is responsible for site monitoring and regulatory activities associated with clinical trials in organ and islet transplantation, autoimmune diseases and asthma and allergic diseases. The work to be performed under this contract is currently being carried out by PPD Pharmaco, Inc., under a subcontract to The EMMES Corporation under contract N01-AI-95382. We are seeking to absolve the subcontracting arrangement by soliciting this activity to be awarded as a new contract. Work to be performed includes: 1) monitoring of clinical research studies conducted by the ITN; 2) initiating and monitoring of sites and pharmacies conducting DAIT-supported ITN studies in the United States and abroad; and monitoring of laboratory facilities and procedures for obtaining testing and storing clinical research specimens, when requested as a special assignment; 3) training site personnel on good clinical practice and on the policies and procedures established by DAIT, the Food and Drug Administration (FDA), the Office of Human Research Protections (OHRP) and the ITN; 4) recruiting and training site monitors; 5) providing reports on monitoring findings and training activities; 6) collaborating with DAIT and the ITN; and 6) facilitating an orderly transition to a subsequent contractor. For purposes of determining your related capabilities, you may assume: 1) the ITN will be enrolling and following subjects in approximately 15 to 20 Phase I or Phase II trials with the total enrollment for each study ranging from 10 to 200; 2) the number of clinical sites for ITN studies will range from 1 to 10, with the majority of studies conducted at 1 to 3 sites; 3) the majority of the sites will be in the United States but as many as 5 to 8 sites may be in Canada or Europe; and 4) it is estimated that the ITN would initiate 5 to 6 new studies per year. All capability statements will be evaluated against related ability and experience for monitoring clinical sites and their pharmacies and laboratories; training site staff in policy, procedures and good clinical practices; monitoring domestic and international clinical sites; ability to recruit a full monitoring staff within four months of contract award with minimum Bachelor's Degree or equivalent in nursing, pharmacy, biology or other biomedical sciences; sufficient number of monitors possessing special international site monitoring qualifications; adequacy and availability of professional staff other than monitors; and documented evidence of successful organizational experience in providing monitoring services for multi-site clinical trials. It is anticipated that this contract will be for a 7-year period of performance and require an estimated 9 to 10 FTEs 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 which states: - 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 scientist, engineers and technical personnel who may be assigned as a principal investigator and/or project officer; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration. A statement regarding industry security clearance. Any other specific and pertinent information as pertains to this particular area of procurement 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.
