Clinical Data Interchange Standards Consortium Membership Renewal

General Information Short Title: Clinical Data Interchange Standards Consortium (CDISC) Membership Renewal Document Type: Presolicitation Notice Solicitation Number: N02CO82505-36 Posted Date: 11/3/2017 Response Date: 11/14/2017 Classification Code: B529-Scientific Data Studies NAICS Code: 518210 - Data Processing, Hosting and Related Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that provides federal regulatory standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve clinical research. There is no comparable organization, as CDISC standards are cited in guidance for data submissions to FDA with which the NCI must comply. The NCI maintains an institutional membership in this organization and participates as a major partner and collaborator in the development of these standards, which are required for clinical and pre-clinical data submissions to the FDA and other international regulators. There is no comparable or competing organization for the development of these standards. The NCI organizational membership provides conference discounts, free educational meetings, access to all CDISC intellectual products such as implementation guides which are used by NCI, access to all data in the CDISC SHARE database, and representative positions on CDISC Advisory Groups. The purpose of the acquisition is to procure CDISC membership. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 518210 and the business size standard is $32,500,000. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract with a base and four option periods. It has been determined there are no opportunities to acquire green products or services for this procurement. CDISC works with NCI on various regulated research data standards, such as for standardized case report forms, research domain models including the Biomedical Research Integrated Domain Group (BRIDG) model, and other products that provide a common framework for data exchange. CDISC is working actively with NCI's Enterprise Vocabulary Services to develop and support controlled terminology in several areas, notably CDISC's Study Data Tabulation Model (SDTM). SDTM is an international standard for clinical research data, and is required by the FDA as a standard electronic submission format. Common data collection and submission standards that are collaboratively developed include: CDISC SDTM, which includes standard terminology covering demographics, interventions, findings, events, trial design, units, frequency, and ECG terminology. FDA currently receives submissions using this standard. This terminology is maintained and distributed as part of NCI Thesaurus. CDISC Clinical Data Acquisition Standards Harmonization (CDASH) Standard, a clinical research study content standard developed in collaboration with sixteen partner organizations including NCI. NCI EVS maintains and distributes CDASH controlled terminology as part of NCI Thesaurus. CDISC Analysis Data Model (ADaM), which supports efficient generation, replication, review, and submission of analysis results from clinical trial data. NCI EVS maintains and distributes ADaM controlled terminology as part of NCI Thesaurus. CDISC also leads the Standard for the Exchange of Nonclinical Data (SEND) project, which guides the organization, structure and format of standard preclinical tabulation data sets for interchange between organizations such as sponsors and CROs, and for submission to a regulatory authority such as the FDA. FDA currently receives submissions using this standard. NCI EVS maintains and distributes SEND controlled terminology as part of NCI Thesaurus. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on November 14, 2017. All responses and questions must be in writing and faxed +1 (555) 000-0000 or emailed to David Romley, Contract Specialist OR via electronic mail at contact@example.gov. 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 System for Award Management (SAM) through sam.gov. Reference: N02CO82505-36 on all correspondence.