Medidata Rave & Integrated Products/Services

The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI) intends to award a sole source contract utilizing the authority of FAR 6.302-1 to Medidata Solutions, Inc. This notice is not a request for competitive proposals. In 2008, the NCI procured a perpetual license for Medidata Rave for use by NCI sponsored organizations for oncology related research. The perpetual license grants to the NCI and its authorized users a perpetual use license to Medidata applications solely for unlimited usage rights within the boundaries of the NCI Clinical Research Enterprise for an unlimited number of studies. Medidata Rave (herein after referred to as Rave) is an Electronic Data Management (EDC) and Clinical Data Management System (CDMS). An EDC/CDMS is the primary tool utilized by researchers, physicians and other health care professionals to communicate and track scientific and safety data related to an experimental cancer trial. The primary NCI users of Medidata Rave are the National Clinical Trials Network (NCTN), Experimental Therapeutics Clinical Trials Network (ETCTN), National Community Clinical Oncology Program (NCORP), and several smaller NCI multi-center consortia. To support the NCI's oncology related research, NCI is in need of hosting, maintenance, and support/training services to support the NCI owned perpetual license for Medidata Rave. This notice of intent to award a sole source contract is not a request for competitive proposals; However, in accordance with FAR 5.207(c)(16)(ii), all responsible sources that feel they can provide all the services/products identified herein, may submit a capability statement/proposal/quotation which shall be considered by the agency. Capability statements/proposal/quotation shall be tailored to clearly convey its ability and/or experience to provide all the requirements identified herein. The Contractor shall provide: a) Hosting, maintenance and professional services for Rave for approximately 14 production and test URLs. b) License, hosting, maintenance and professional services for ancillary Medidata Rave-integrated software products that have been integrated with NCI IT infrastructure and business processes, identified below, for 10 Rave URLs (Note: The Government may exchange other URLs.), for use in NCI sponsored trials. i) Targeted Source Data Verification (TSDV) ii) ePRO iii) Balance c) The Government may require additional increased capacity to support: 1. New Medidata ancillary software products - License, hosting, maintenance; and professional/training services to support implementation. 2. New URLs - Hosting, maintenance and professional services for new Rave URLs and Medidata ancillary products. 3. Additional Studies to leverage ancillary Software products. 4. Additional Professional services. The period of performance for this contract shall be for a base period of 12 months (anticipated to start September 1, 2018), with four (4) 12-month option periods. Qualified firms must also include the following information in their capability statements/proposal/quotation: a) Company Name. b) DUNS Number. c) Company point of contact, mailing address, telephone number, and website address. d) Name, Telephone number, and email address of a company point of contact who has the authority and knowledge to clarify responses with Government representatives. e) Date submitted. f) If Applicable: GSA schedule number, or other available procurement vehicle. g) Do you have a Government approved accounting system? If so, please identify the agency that approved the system. h) Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). i) All respondents must be registered and validated on SAM (https://www.sam.gov). The resultant contact will be award using the procedure prescribed in FAR 15 - Contracting by Negotiation, and will include all applicable provisions and clauses in effect through FAC 2005-97 (effective January 24, 2018), and HHSAR effective December 18, 2015). It is the responsibility of the Contractor to be familiar with the applicable clause and provisions. The clauses may be accessed in full text at these addresses: FAR - https://www.acquisition.gov/far and HHSAR - https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html. No solicitation document is available. The information received will not be returned and will be retained as Market Research. Capability statements/proposals/quotations must be submitted to the contact point at the email addresses given below. Capability statements/proposals/quotations will not be accepted after the due date. The maximum number of pages for submission is three (3) pages. If no capability statements/proposal/quotations are received which specifically demonstrate the ability to meet all the requirements identified above, the Government shall proceed with a sole source contract to Medidata Solutions, Inc. All capability statements must be submitted in Adobe Portable Document Format (PDF). In order to be considered, all responses must be received by the specified due date and time. All responses must be submitted electronically to Margo Katzper at mkatzper@mail.nih.gov, and Jame Chang at jame.chang@nih.gov by 3:00 PM Eastern on April 5, 2018 and must reference NO2CO71014-.40. Hardcopy or faxed responses will not be accepted. 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 to allow the Government to determine the organization's qualifications to perform the work. 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. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).