SOLICITATION NOTICE
R -- Clinical Research Database Support
- Notice Date
- 9/15/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-11-110
- Archive Date
- 9/23/2011
- Point of Contact
- Tina Robinson, Phone: 301-443-7796
- E-Mail Address
-
tr207f@nih.gov
(tr207f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 NICHD-11-110 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 2005-53. The North American Industry Classification (NAICS) Code is 541712 and the business size standard is 500 employees. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intend to contract on a sole source basis with DM-Stat, Inc - 1 Salem St. - Suite 300 - Malden, MA. DM-Stat will continue to provide consultation and services to the assist the Perinatology Research Branch (PRB) in the development of a research clinical database. Period of performance: four (4) months. Background: The PRB is located at Detroit Medical Center (DMC) within the Hutzel Women's Hospital and Wayne State University (WSU) in Detroit, MI. The research database the PRB requires must have the ability to interact with the DMC and WSU systems as well as the PRB systems ObPro, Viewpoint, Cordo, etc. The University has OB/Gyn research database that obtains data electronically from the DMC. The NIH has a service contract with WSU to support the PRB. The contract requires that there be an electronic medical record that would be available to the PRB to support our research. The EDC system Prism is being developed to meet that requirement. Therefore, the Prism system is a shared resource supporting both the WSU Ob/Gyn Department research and the PRB research. DM-Stat was selected by WSU to perform work on an Electronic Data Capture system (currently PRISM). The University conducted a full and open competition according to its procurement policies with an advertised public request for proposals and negotiations with multiple vendors. DM-Stat was selected through that process on the basis of cost and ability to perform the required work. The PRB was allowed to participate in developing the specifications for the WSU solicitation and in discussions with the vendors but the final decision was made by the WSU Purchasing Department. DM-Stat has been on site in Detroit and as well as working remotely on that project for over a year. This is an ongoing relationship with WSU and DM-Stat will continue to support both the WSU research and by extension, services to the PRB. Both WSU and the PRB interact with the same patient population here at the Detroit Medical Center, thus DM-Stat is very familiar with the Medical Center and the University. In addition to the shared resource (PRISM), the PRB currently has its own unique requirements apart from the shared needs that are currently needed including specimen information containing 10,000 patients that will allow the execution of research pertaining to perinatology/pregnancy related studies. The current scope of work/Statement of Work needed is a continuation of the services that DM-Stat has been providing to include consultation and services to the assist the Perinatology Research Branch (PRB) in the development of a research clinical database as well as but not limited to: • Determining patient selection criteria • Developing written Case Report Forms (CRF) for each PRB protocol • Develop written CRF completion guidelines and assist in training PRB personnel in the use and completion of CRFs, • Advise the PRB on the existing Electronic Data Capture (EDC) system Prism and provide specifications and a testing plan to further refine that system • Establish a process for CRF Tracking and a Data Entry Manual • Establish a process for converting data elements in to database coding to facilitate access to the data • Establish an Adjudication Plan that results in well-characterized patient population (i.e. distinguishes controls from diseased individuals • Proposes an External Data Processing Plan • Executes a Data Validation Procedure • Database Lock and Archiving Procedures • Determine procedures and the database structure to indicate specimens collected and amount of specimen for a given sample • DM-STAT will provide all the necessary personnel for the performance of the Statement of Work and • DM-STAT will be available for meetings (some on-site @ PRB location) and telephone consultation relevant to the scope of the Statement of Work The Case Report Forms of the PRB would be separate from those of WSU but the data may reside in the PRISM system. In addition, there are several unique legacy data sources that we are attempting to consolidate into one place as a data warehouse (known as PRB Central) that would tie to the transactional database (PRISM). DM-Stat, in performing services for WSU, has had to become familiar with the needs of both the PRB and WSU in order to assist in developing a system that can meet the needs of both. DM-Stat has spent considerable time and effort to understand the details of the PRB's unique databases (ObPro, Viewpoint, Cordo, a database from collaborators in Chile, our Biological Sample Inventory database, etc.) in order to understand how that data would ultimately connect in an effective way to the PRISM system. This included reviewing all of the PRB protocols (approximately 12) and understanding the processes of the PRB personnel from the nursing staff who collect the samples, to the lab where they are processed, to the bank of biological materials where the samples are stored and ultimately to the researchers who request access to specimens and data to conduct research. DM-Stat has extensive experience in Government contracting. DM-Stat has specific knowledge of the data requirements for pregnancy-related studies through its experience in the FASTER trial. This was a large, prospective observational study sponsored by NICHD. DM-Stat is familiar with the protocols of the PRB and has worked in generating a database for 4,171 patients enrolled in a longitudinal study o the PRB. Therefore, DM-Stat has firsthand knowledge of the protocols, data collection site, hypothesis under study and the goals of the observational studies. If a vendor other than DM-Stat were to be awarded the contract to support the needs of the PRB, that vendor would be required to duplicate the efforts of the past year+ between the three, DMC, WSU and the PRB regarding the EDC system, etc. This duplication of effort and cost would be substantial to the government and is not expected to be recovered through competition. Thus, the time required would be substantial before another vendor would be in a position to be fully up to speed and able to be in a position to assist the PRB with its unique database needs. The other vendor would also have to establish or already have a working relationship with DMC and WSU in all aspects of the services needed, etc. Since the EDC system is a service provided by WSU an established relationship with WSU is critical to the PRB and their current and future project/research. These factors would have a significant impact on our work/research being delayed/push back as far as monetary and time wise if a vendor (besides DM-Stat) was contracted to perform such services. From our perspective, we believe it would be most cost and time effective for NICHD if DM-Stat were to provide the current services needed. DM-Stat was selected by WSU through vigorous full and open competition to find a capable and cost effective vendor. DM-Stat has extensive experience in providing these services for clinical trials, observational and longitudinal studies for the government and for other entities. NICHD can take advantage of that investment by WSU by selecting the vendor with knowledge and experience of the research environment and needs. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c)(1), FAR 6.302-1(iii). This notice of intent is not a request for competitive quotations however, all responses received, within 7 days from the date of publication of this synopsis will be considered by the Government. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at https://www.acquisition.gov/Far/. Interested vendors capable of furnishing the government with the service specified in this synopsis should submit two (2) copies of their quotation to the below address. Quotations will be due seven (7) calendar days from the publication date of this synopsis or by September 21, 2011 by 1pm EST. The quotation must reference "Solicitation number" NICHD-11-110. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Offers must also be accompanied by descriptive literature, warranties and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations must be submitted in writing to Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 5Z00, Rockville, MD 20852. Attention: Tina Robinson. Faxed copies/responses will not be accepted. Email copies/responses will not be accepted. Questions must be submitted via email to robinsti@mail.nih.gov and must have the solicitation number NICHD-11-110 in the subject line of the email. Note: In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) http://www.ccr.gov
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