SOURCES SOUGHT
A -- Data Coordinating Center for the Pediatric Off-Patent Drugs Study (PODS) Centers
- Notice Date
- 9/26/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- RFP-NICHD-RFP-2003-02
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - Harvey Shifrin, Lead Contract Specialist, Phone 301-435-6963, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, hs35h@nih.gov
- Description
- The National Institute of Child Health and Human Development(NICHD), National Institutes of Health (NIH) is planning to study up to 180 pediatric off-patent drugs under the Best Pharmaceutical for Children Act (BPCA) law in the next five years. Each drug study will have different PODS centers comprised of up to fifty (50) clinical sites, depending upon the requirements of each drug study. NICHD is planning to award a contract for a Data Coordinating Center for the Pediatric Off-Patent Drugs Study (PODS) centers. The purpose of this synopsis is to determine whether there are small businesses with the requisite qualifications to perform the proposed study. The organizations shall have the following qualifications: 1. Experience in conducting,organizing, managing and monitoring multiple pediatric clinical drug trials (estimated up to 180 drugs, each drug study may have up to 50 study sites). 2. Capability and experience to integrate the operations of all PODS Centers in performing studies of off-patent drugs for pediatric indications. 3 Capability in monitoring the quality of data gathering,data editing, data auditing, data entry, and data analysis. 4. Capability in developing and maintaining information systems for specified tasks needed to determine the safety and effectiveness of drugs for specific pediatric indications. 5. Capability of identifying and proposing appropriate new study PODS Centers, if necessary. 6. Capability in establishing and maintaining a database of all studies performed under the Best Pharmaceutical for Children Act (BPCA) that can be used for research, regulatory and reporting purposes. 7. Capability of creating and maintaining a database of all studies performed animals and humans relevant to the clinical trials being conducted in infants and children. 8. Capability in preparation of data and data analysis for publication on the FDA docket as well as in peer reviewed publications. 9. Capability and experience in managing simultaneous conduct of multiple clinical trials and managing a large volumes of time-sensitive data. 10. Capability and experience in regulatory affairs including electronic submissions, Investigational New Drug (IND), and New Drug Application (NDA) submissions. 11. Capability in quality control procedures, including adherence to good clinical and laboratory practices, site audits, in-house data base audits and database validation. 12. Capability and experience with clinical research activity in the pediatric population. 13. Capability and experience in interacting with pharmaceutical companies, research organizations, academic centers, NICHD and FDA. 14. Capability and experience in training and certification for data coordinators and clinical investigators located in a number of study sites. 16. Capability and experience in the management of pediatric clinical drug trials. 17. Qualified personnel to assume work to integrate new PODS Centers within 30 days following the contract award to new PODS Centers. 18. Capability in developing and implementing a standard operation procedure that details relationships and responsibilities between the Coordinating Center and the Clinical trials Offices of PODS Centers.. 19. Capability and experience in preparation of IND applications and amendments and submissions required by the FDA. 20. Capability and experience in establishing and maintaining a communication system in compliance with U.S. Food and Drug Administration (FDA) requirements for the submission of Adverse Event Reports (AERs) by PODS Centers. 19. Capability in monitoring accuracy of adverse event reporting. 20. Capability and experience to make sure that each clinical site has a current, approved Federal Wide Assurance Number on file with the Office for Human Research Protection (OHRP) An organization capable of performing the above should submit a statement of capabilities (5 copies) with documentation supporting its capability to: Mrs. Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, 6100 Executive Blvd., Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510. email address: mh89m@nih.gov, telephone (301) 435-6958.
- Record
- SN00176188-W 20020928/020926213330 (fbodaily.com)
- Source
-
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