Database Software

Sources Sought Notice Announcement Number: HHS-NIH-NHLBI-SS-159 Title: Database Software Post Date: June 5, 2012 Closing Date: June 20, 2012 Proposed Award Date: August 3, 2012 The National Heart, Lung, and Blood Institute is seeking sources to provide database software to access information about the costs of all aspects of conducting clinical trials. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. It is anticipated that one award will be made b for a period of three years. The NAICS code applicable to these services is 541519 - Other Computer Related Services with a business size standard of $25.5 million. Background: In order to provide appropriate and responsible oversight, NHLBI requires objective benchmarks for evaluating pre-review budgets of proposed clinical trials and other large clinical research projects. At this time, NHLBI does not have ready access to robust databases that can be used for this purpose, and NHLBI has no ongoing projects to create one. At present, clinical research projects that will cost more than $500,000 per year (direct costs) must undergo a pre-submission review process, hereby referred to as - the 500K process, which is conducted by Institute staff. NHLBI staff consider assessment of the proposed budget to be a critical component of the 500K process, but the only data that NHLBI staff have at present to evaluate costs is whatever information the applicant provides. Through experience we have found that applicants pre-review estimates often turn out to be inaccurate. The consequences can be serious; if the pre-review estimate is too low, NHLBI finds itself being asked for additional funds once the trial is well underway, making refusal difficult. If the estimate is too high, NHLBI and its investigators suffer from substantial opportunity costs. NHLBI would prefer to have an accurate up-front estimate, or range of estimates, of the total costs. Purpose and Objectives for the Procurement: The purpose of this procurement is for NHLBI to obtain access to robust information about the costs of all aspects of conducting clinical trials in cardiovascular, pulmonary, sleep, and hematology/thrombosis science, in all age groups including pediatrics. NHLBI would like to use this information in two main ways: 1. To estimate, at a high level, the total costs of conducting specific clinical trials based on letters of intent submitted by applicants as part of NHLBI's 500K process. 2. To estimate more precisely the costs of conducting specific clinical trials that NHLBI proposes to fund before the final budget is approved. Contractor Requirements: To achieve the objectives, NHLBI requires the following specific tasks: 1. Estimating costs from the letters of intent. Every year, NHLBI processes between 30 and 40 letters of intent for clinical trials with costs >$500K. These letters, which are up to five pages long, contain a summary of the proposed clinical trial, the number of subjects to be recruited, a general description of study procedures and any core laboratories, the number and general location of clinical sites, and the length of follow-up. Specific tasks related to this component of the work include: a. NHLBI will provide the letters of intent electronically to the contractor as soon as the letters are received. Any budget information provided by the applicant will be redacted, so that an independent estimate can be made by the contractor. b. Within two calendar weeks, the contractor will provide electronically a range of high- level estimates (high, medium, low) of the total costs of the proposed clinical trial. i. The information that will go into the estimate of total costs will include, but not be limited to: costs attributable to research procedures (specialized tests that are for research purposes only and not part of routine care), costs of research processes (e.g., drawing blood, contacting subjects, coordinating study procedures); costs of data management and analysis, costs of central coordination (e.g., identifying and training sites, preparing regulatory documents, establishing and operating laboratories for the central interpretation of results such as imaging studies or lab tests, or the central storage of biospecimens). ii. The two-week time frame should include both the analysis of costs and time to discuss with NHLBI staff any needed points of clarification. iii. These estimates will be produced from a database that the contractor has previously assembled. This database should include data from clinical trials in all age groups, including pediatric populations, as well as data from clinical trials covering cardiovascular, pulmonary, and hematology/thrombosis medicine. The data available should be sufficiently robust to provide stable cost estimates. 2. Providing detailed cost estimates for clinical trials NHLBI proposes to fund. Every year, NHLBI funds 5-10 clinical trials with costs exceeding $500K/year. For these trials, NHLBI works with the investigators to create a budget for the 5-7 years that the research will require. Specific tasks related to this component of the work include: a.NHLBI will provide detailed protocols to the contractor as soon as they become available. b.Within thirty days, the contractor will provide electronically a detailed budget estimate for the clinical trial, based on the detailed protocol. This will include the elements mentioned in the previous task, but at a more detailed level, based on the additional detail that will be in the protocol that wasn't in the letter of intent. 3. Building and refining the dataset. a. The contractor will continue to add data to the dataset from other sources. b. The contractor will add data from NHLBI studies to the dataset. c. The contractor will develop a plan to review cost and budget data that NHLBI already has in-house on previous clinical trials to add additional information about government- funded trials to the dataset. Government Responsibilities: NHLBI will provide the letters of intent and the detailed clinical trials protocols to the contractor in a timely fashion. NHLBI will provide access to existing data on the costs of clinical trials to the contractor. If an interested organization believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must demonstrate the ability to perform the tasks as described above. All responses must be received in writing and must contain material in sufficient detail to allow the NHLBI to determine if the organization is capable of performing this requirement (responses should not exceed 20 pages including attachments). Responses providing insufficient information will not be considered. This is not a Request for Proposals (RFP), nor is an RFP available. All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Evanthia Bouzis, Contracting Officer, at bouzise@mail.nih.gov in either MS Word, or Adobe Portable Document Format (PDF), by Wednesday, June 20, 2012, 2:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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).