SOLICITATION NOTICE
R -- Data Management, Monitoring, and Analysis of Complementary and Alternative Medicine Clinical Trials (DMMA)
- Notice Date
- 9/7/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- N02-AT-45030-70
- Response Due
- 10/25/2004
- Point of Contact
- Erin Lange, Contracting Officer, Phone (301) 435-3830, Fax (301) 402-8579,
- E-Mail Address
-
el45g@nih.gov
- Description
- The National Center for Complementary and Alternative Medicine (NCCAM) is seeking a Clinical Trials Data Management and Monitoring Service with the capability to create and manage an intramural database requiring data organization, maintenance, quality control, and analysis and to provide ongoing monitoring of clinical studies. Additionally, NCCAM seeks an independent contractor to perform monitoring audits of extramural studies to confirm adherence to study protocol, the integrity of data collected on study, and the appropriateness of the data analysis. The contractor shall be responsible for the following tasks: (1) To develop manuals of procedures, study forms, and procedures. (2) To supply all study forms, copies of the study protocols and other materials to the appropriate study participants, and shall receive all information pertinent to each study from study clinical center(s), referring physicians, or laboratories and shall be responsible for the inventory and storage of these materials. (3) To provide monitoring of all approved studies for the occurrence of adverse events and adherence to adverse event reporting guidelines as defined in the study protocol(s). (4) To design, develop, and implement a computer database system that will receive, inventory, and store all clinical and laboratory data as defined by the protocol and case report forms (CRFs). To design and implement edit systems to insure completeness, quality, and uniformity of all data. Upon the effective data of the contract, the contractor shall have, on-line and operational, computing capabilities and all other capabilities necessary to perform all aspects of the statement of work. (5) To prepare analyses of all data as requested. (6) To assist the study investigators in the preparation of reports for scientific presentations and publication. (7) To provide management, methodology, and cost analysis to meet demands resulting from the NCCAM approved protocols, protocol changes, documentation revisions, and requests for analyses, reports and publications. (8) To provide extramural study monitoring audits. The contractor will be required to perform 1 – 5 monitoring/auditing visits to funded study sites per year to check electronic data against the source documents. The Government anticipates that one (1) contract will be awarded on a Cost Reimbursement, incrementally funded basis, for a period of five (5) years. This acquisition has been designated as full and open competition under NAICS Code No. 541990 with a size standard of $6 million. The solicitation is scheduled for electronic release approximately September 22, 2004. The RFP may be accessed through Internet address: http://rcb.cancer.gov/rcb-internet/. It is the offeror’s responsibility to monitor the above Internet site for the release of the Solicitation and Amendments, if any. POTENTIAL OFFER’S WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Erin C. Lange, Contracting Officer at e-mail: el45g@nih.gov/ FAX: 301-402-8579; Telephone: 301-435-3830. No collect calls will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (07-SEP-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 26-MAY-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/RCB/N02-AT-45030-70/listing.html)
- Record
- SN00816772-F 20050528/050526214241 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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