SOLICITATION NOTICE
R -- Continued Clinical Trial Management
- Notice Date
- 12/7/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541614
— Process, Physical Distribution, and Logistics Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-50010-NV
- Response Due
- 12/16/2004
- Archive Date
- 12/31/2004
- Description
- The National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Molecular Biology (LMB) intends to procure on a sole-source basis with Synergos Inc., 2202 Timberlock Place, Suite 230, The Woodlands, TX 77380 for the continued clinical trial management of two ongoing Phase I studies of SS1PE38. The LMB uses genetics, molecular biology, cell biology, and molecular modeling to examine and solve a broad range of important biological problems. In the Molecular Biology Section, one major program is directed at designing, producing, and testing new drugs (immunotoxins) to treat cancer. In late 2002, the CRADA partners, who were running the SS1PE38 Phase I clinical trials terminated the CRADA and gave up the license for this drug. At that time the license and the IND (Investigational New Drug document required by the FDA) was taken over by CTEP (Cancer Treatment Evaluation Program) at NCI. In early 2003 a purchase order (263-MQ-309810) with Synergos, Inc was set up to assist in monitoring, project management, data management, statistical services, and regulatory support for the Phase I clinical trials on SS1PE38, which was developed in the LMB. Due to difficulties in the recruitment of patients, coupled with the designs of the two clinical trial protocols themselves, there has been a delay in finishing the trials and additional clinical trial management is required from Synergos. Synergos has possession of all the data from the patients treated by the original CRADA partners that NCI does not have the rights to. In addition there are currently patients enrolled in these trials and any breaks in their treatment could be catastrophic. The time to transfer all the information, and data files and bring a new company up to maximum operating levels would be very extensive and delay the completion of the Phase I trial jeopardizing the treatment of cancer patients. Continuity and time constraints are crucial to the clinical trials and Synergos Inc., is the only known source. This is not a solicitation for competitive quotations. However, if any interested party believes it can meet the entire above requirement, they may submit a statement of capabilities. All information furnished shall be in writing and must contain sufficient detail to allow the NCI researcher to determine if it can meet the requirements of this synopsis. This acquisition will be processed under FAR Part 12 ? Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. An original and one copy of the capability statements must be received in the Contracting Office by 1PM EST (local Washington, D.C. time) on December 16, 2004. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. NAICS: 541614; Size Standard is 6 million.
- Place of Performance
- Address: Bethesda, Maryland
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00717798-W 20041209/041207211705 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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