Translational Research Informatics and Operations Support (TRIOS)

Purpose This is a Request for Information (RFI) only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), will take procurement action in this matter. This is NOT a solicitation for proposals, applications, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information to assess the current state of the science. Further, neither DHHS/NIH/NCATS nor the Government will be responsible for any cost incurred in furnishing this information. The NCATS is seeking information regarding state of the art electronic, web-based, customizable information management systems with the ability to receive and track information about clinical and translational research. The purpose of the system is to allow multiple users, including NCATS staff and NCATS funded investigators and collaborators to input, provide, and obtain information about planned, ongoing, and completed translational research. The system will integrate data from multiple sources and inputs including data systems maintained by NIH, NCATS funded collaborators and data coordinating centers, and individual investigators. The data system is not intended to be the clinical data management system and will not collect or receive clinical study data. Background As part of its overall research mission, NCATS has an extensive clinical research portfolio that covers a broad range of clinical efforts. Currently, most of the clinical and data coordination efforts are accomplished through a decentralized approach with unique arrangements being made for each study. Coordination across these various entities, as well as centralized operations support and oversight, will be sought. Information Requested Organizations are invited to submit a white paper describing electronic, web-based, customizable, and secure data systems. Responses should be tailored to the information requested, taking into consideration the "Purpose" and "Background" described above. Respondents should include, but are not limited to, addressing their experience and capabilities in the following areas: a) Providing novel approaches, methods and data systems for aggregating translational research information from multiple sources, establishing portals for stakeholders to easily provide and receive data and documents and obtain tools, reports, announcements, and reminders via a dashboard or other electronic messaging. b) Quickly and accurately setting up and managing an integrated data system that can receive and disseminate translational and clinical study information, documents and workflow in a secure, flexible manner for multiple users. c) Securely capturing and managing grant information, protocol and related documents, information about the protocol such as study title, description, study status, study life-cycle milestones, metrics, participating sites, data and safety monitoring activities actions and documents, and other key study information, such as date IRB approval, study start date, date of monitoring, etc. d) Supporting similar large translational and clinical operations programs. Responses should be limited to 5 pages, not including the cover page, cover letter, table of contents and graphic displays of data system integration. RFI responses must include: 1) name and title of the primary point of contact for the response; 2) name and address of the institution or company; and 3) email address and phone number of the primary point of contact Responses are due by January 19, 2016 Disclaimer and Important Notes This Notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this Notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this Notice will not be considered adequate responses to a solicitation. Confidentiality Any proprietary information should be clearly marked and will be kept confidential in accordance with federal law. The Government reserves the right to use any non-proprietary information in any resultant solicitation(s). Inquiries & Responses Inquiries and RFI Responses should be directed to the NCATS R&D Contracts Management Branch Point of Contact (POC): Amanda Gramlich, at Amanda.gramlich@nih.gov. The alternate POC is Jeffrey R. Schmidt, at schmidtjr@nida.nih.gov.