SOLICITATION NOTICE
A -- NIDCR Clinical Trials Operations and Management Support
- Notice Date
- 10/4/2007
- Notice Type
- Solicitation Notice
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NHLBI-DE-08-16
- Response Due
- 10/19/2007
- Archive Date
- 10/31/2007
- Point of Contact
- Richard Phillips, Contracting Officer, Phone 301-402-6462, Fax 301-480-3432
- E-Mail Address
-
rp235k@nih.gov
- Description
- The National Institute of Dental and Craniofacial Research (NIDCR) is conducting a market survey to determine the availability and potential technical capabilities of small business firms to provide comprehensive clinical research and clinical trials operations support, management and data coordinating services for NIDCR-sponsored clinical research and clinical trials. The applicable NAICS code is 541710 and the size standard is 500 employees. PLEASE NOTE THAT THE NAICS CODE WILL BE REVISED TO 541712 IN ALL FUTURE NOTICES FOR THIS PROGRAM. The purpose of this project is to provide NIDCR with clinical research management support and oversight tools to assist in the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. One award is anticipated under a separate RFP. The potential contractor must provide a wide range of clinical trial management services for a variety of clinical research efforts supported by NIDCR. Services include: 1) consulting/collaborating on study design, protocol development and protocol and adjunctive study document preparation, including the design of case report forms, consent forms, study manual of procedures and source documentation; 2) clinical site preparation and clinical trial operational assistance; 3) study data collection, management and quality control; 4) training of clinical study site personnel; 5) regulatory support and FDA coordination; 6) special clinical trial operations support (e.g. drug packaging, labeling and shipping, clinical specimen storage, pilot lot production, and pre-clinical testing); 7) clinical monitoring/auditing; 8) pharmacovigilance/safety monitoring; 9) statistical design and analysis; 10) safety monitoring; 11) information management functions, including website development and database management; and 12) general administrative and logistical support. The potential contractor must provide appropriate and multi-disciplinary staff with relevant experience in a broad array of clinical research management associated with the planning, implementing and conduct of Phase I-III clinical trials as well as population-based and epidemiologic and natural history studies in both domestic and international settings. Small business firms having demonstrated experience in performing the above-mentioned tasks are invited to submit capability statements (original and two copies). Capability statements must provide evidence of experience in performing the tasks described above and demonstrate the following: (1) Experience: An outline of previous projects which are similar in nature to the work scope described in this notice; 2) Personnel: Qualifications and availability of personnel with relevant and pertinent experience to perform the work described above; (3) Facilities: Availability and description of specific facilities and other resources required to perform the work; 4) the ability of the organization to effectively manage subcontracts, if it cannot provide all of the anticipated services in-house, and maintain complete and effective labor, technical, and management control of the program; and 5) Documentation to support the firm?s status as a small business under NAICS code 541710. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. This is NOT a Request for Proposals (RFP), and responses should not include budgetary information. The RFP release date is pending. The Government intends to negotiate one (1) cost-reimbursement contract for a period of five (5) years with an approximate award date of September 30, 2008. Firms responding to this market survey should provide information pertinent to the requirements mentioned above (original and two copies) within 15 calendar days of the date of this announcement to the address shown below: Office of Acquisitions, DERA, NHLBI Attention: Rick Phillips, Contracting Officer 6701 Rockledge Drive RKL2/Room 6132 MSC 7902 Bethesda, Maryland 20892-7902 Phone 301-402-6462 email: phillipr@nhlbi.nih.gov
- Record
- SN01428614-W 20071006/071004223341 (fbodaily.com)
- Source
-
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