CLINICAL DATA MANAGEMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NICHD-16-016 and is issued as a Request for Quotation (RFQ). The solicitation /contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-84. The North American Industry Classification (NAICS) Code is 541690 with a size standard of $15000000. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Health (NIH), National Institute of Digestive, Diabetes & Kidney Diseases (NIDDK) has a requirement to procure Clinical data management services. National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) plans to procure services for clinical data management. This contract allows NIDDK to acquire the services for currently operational clinical data information systems within the NIDDK Division of Intramural Research's clinical research program. This agreement is not intended to provide travel related expenses. The anticipated service hours are estimated to not exceed more than 20 hours per week on an averaged basis for the year period this contract is to be approved. The services will be rendered during normal business hours, Monday-Friday, excluding Federal holidays. This contract requires that the vendor (contractor) be already familiar with the NIH and FDA guidelines and regulations for clinical data systems. The contractor shall also be familiar with the key clinical data systems utilized by DIR investigators including, but not limited to TeleResults, REDCap, NICHD's Clinical Trials Database, and NHLBI's Crimson. Working knowledge of the NLM/CC BTRIS is also required. NIDDK requires that the contracted services be conducted by an individual with knowledge of a wide array of clinical databases currently utilized within NIH intramural clinical research projects. This requirement will enable the contractor to provide cost-efficient clinical data solutions to clinical investigators when initiating new clinical protocols, or transitioning data between data systems. Knowledge and experience working with the NIH Clinical Center's CRIS medical records systems is required. The contractor must possess working knowledge of these systems as there is no staff available to provide the training in these systems under the funds obligated via this contract; any such work required to become familiar with these systems would be required to be independently undertaken at the contractor's personal expense and time. Tasks: Provide assistance with the application of computer technology to clinical research by assessing clinical data. Assist with the evaluation of various technical informatics systems to determine applicability for the support of research of specific clinical diseases. Coordinate necessary computer-related activities with the NIDDK Computer Technology Branch as well as the staff supporting clinical database development for other applicable ICs. Train NIDDK personnel to independently manage BTRIS and other clinical data query tools as appropriate. Maintain the current database source code and modify the database source code in consultation with the user base for applicable clinical databases. The contractor shall be issued government accountable property to conduct routine business functions within the scope of this contract. The contractor agrees to take on fiscal responsibility related to the loss, theft, or damage of any issued property. For any work which may require taking the accountable property off-site from the duty station, the contractor shall obtain a government property pass for the device(s). Additionally, the contractor shall agree to complete required training, as applicable, for example, NIH privacy and security training (or refresher). The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors - Commercial items; 2) FAR Clause 52.212-2, Evaluation - Commercial Items. As stated in FAR Clause 52.212-2 (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be advantageous to the Government, price and other factors considered. The following factors will be used equally to evaluate offers: Technical Evaluation, Price, and Past Performance. Note: Past Performance Information: Vendors must submit a listing of the most recent contracts/awards (minimum of 3) which demonstrate similar work in nature to this Solicitation. Contracts/awards may include those entered with the Federal Government, state and local governments and commercial concerns. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number 3) FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items; 4) FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; 5) FAR Clause 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions. The Dun and Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN) and the certification of business size shall be included. The clauses are available in full text at http://www.arnet.gov/far. PLEASE NOTE: In order to receive an award, contractor must be registered and have valid certification in the System For Award Management (SAM) http://www.sam.gov Interested vendors capable of providing the Government with the items specified in this synopsis should submit their quotation to the below address. Quotations will be due fifteen (15) calendar days from the publication date of this synopsis February 8, 2016 at 11:00 a.m. EST. Offersors shall provide an original and two copies of your quotation. The quotation must reference Solicitation number NIH-NICHD-16-016. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5C01, Bethesda, Maryland 20892, Attention: V. Lynn Griffin.