SOLICITATION NOTICE
D -- Electronic Protocol Submission and Institutional Review Board Operations
- Notice Date
- 10/26/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541511
— Custom Computer Programming Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NCI-70005-NG
- Response Due
- 11/13/2006
- Archive Date
- 11/28/2006
- Description
- National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis, services regarding Electronic Protocol Submission and Institutional Review Board (IRB) Operations/Documentation for the NCI IRB (Clinical) and the NCI Special Studies (SS) IRB, with iMedRis Data Corporation, 621 E. Carnegie Drive, San Bernardino, CA 92408. The North American Industry Classification System Code is 541511 and the business size standard is $23M employees. The supplies and services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.501. The purpose of this procurement is to facilitate interaction and improve the quality of clinical research protocol submissions from the NCI DCEG Principal Investigators. NCI is initiating this procurement to have the NCI Special Studies (SS) IRB be consistent with the current NCI Clinical Center IRB (NCI-IRB) in terms of electronic communication and documentation. This is to ensure that both IRB?s for NCI are both consistent and meet regulatory and accreditation standards. Contractor requirements: 1) Implement a comprehensive security program meeting the requirements of the HHS and NIH information technology security policies and guidelines, electronic signature functionality is a requirement, 2) Allow easy accessibility and simple system tutorials for the creation of new applications/submissions, access/update of personal profiles, review existing studies/applications, work on drafts using the library concept of single user check in/out, and generate continuing reviews, amendments, and reports of unanticipated events for submission to name a few. Period of Performance: Twelve (12) months from date of award with four (4) twelve (12) month options. This effort will help ensure that NCI IRBs? (Clinical and Special Studies) continue to keep abreast of the changing Government regulations and institutional policies for research, new technologies and new requirements. In order to support these objectives, the NCI DCEG must incorporate an electronic management system that is consistent with the current NCI wide format. iMedRis is the only source known to the NCI that can provide an electronic management system which is consistent with the current NCI IRB format and is compliant with Government and Institutional regulations and policies. The electronic management system and software is proprietary and owned by iMedRis. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 1:00 PM EST November 13, 2006. Questions must be submitted in writing to Malinda Holdcraft, Contract Specialist, at holdcram@exchange.nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement 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. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Please reference solicitation number NCI-70005-NG on all correspondence.
- Place of Performance
- Address: Bethesda, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01171153-W 20061028/061026220337 (fbodaily.com)
- Source
-
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