NHLBI Clinical Data Management Support Services

Introduction This Sources Sought Notice is for interested small businesses. This notice is NOT a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this notice is to obtain information regarding:  (1) the availability and capability of qualified small business sources; (2) whether small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran- owned; woman-owned; or small disadvantaged; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS Code for this acquisition is 541990 – All Other Professional, Scientific, and Technical Services. Small business organizations must have their size status certified by the Small Business Administration. An organization that is not considered a small business under NAICS code 541990 should not submit a response to this notice. Background The Division of Intramural Research (DIR) of the National Heart, Lung, and Blood Institute (NHLBI) possesses a strong clinical research program whose mission is to advance the detection, diagnosis, and treatment of cardiovascular, pulmonary, and hematologic-related diseases in humans. This mission entails administration of clinical trials that can later be translated into broad clinical practice, thus enabling advances in basic science to impact public health. The DIR takes full advantage of its basic and translational research environment in which patients can be studied intensively to gain valuable pathophysiologic insights coupled with basic, bench research to uncover fundamental mechanisms and functions. The DIR’s clinical protocol portfolio is comprised of more than 160 active Phase 0/I/II/III interventional therapy, observational/natural history, and cardiovascular imaging protocols. Approximately 30% of these protocols involve Investigational New Drug (IND) or Investigational Device Exceptions (IDE), the majority of which are held within the DIR. Each protocol is conducted by a team of Associate Investigators and Research Nurses under the direction of a DIR Principal Investigator. The protocols are performed primarily at the National Institutes of Health (NIH)’s Clinical Center in Bethesda, Maryland; however, certain protocols have all or some of their research subjects evaluated or treated at other sites throughout the country. The DIR’s Scientific Director and Clinical Director are responsible for the comprehensive management and oversight of the DIR clinical research program. Day-to-day oversight and administration of the program is provided by the Office of the Clinical Director (OCD). Objectives The primary objective of this acquisition is to provide comprehensive data management support to the DIR clinical research program. This includes all data management functions, utilization of current and legacy databases, and quality assurance measures in accordance with standard operating procedures as required by the OCD and Federal law. Project Requirements Task 1. Clinical Data Managers. Contractor shall employ a team of 20 full-time, qualified Clinical Data Managers (CDMs) to meet the data management needs of the DIR’s clinical research teams. Under the direction of the OCD, Contractor shall assign CDMs to work on specific protocols, research areas, and/or research teams. CDMs shall exhibit the highest level of professionalism in their work and interactions with Federal government employees and other contractor staff. CDMs shall work collaboratively with clinical research staff to meet protocol objectives and further the DIR’s mission through successful execution of the following subtasks: Subtask 1.1. Research Data-related Activities. Under the direction of the OCD and in accordance with DIR standard procedures, CDMs shall be responsible for all research data-related activities for each protocol. Such activities include but are not limited to the following: Gather and enter protocol data into databases according to the specific needs of each protocol Develop and structure protocol-specific data management processes Abstract and grade Adverse Events Run scheduled and ad-hoc reports for Research Teams Prepare data/reports for routine audits from clinical research monitors Prepare data/reports for audits from regulatory agencies and sponsors Participate in the reconciliation of data discrepancies identified in monitoring visits and audits Participate in the clinical research team meetings Assist with monitoring activities Prepare for and assist with site monitoring visits (SMVs) Assist clinical research teams with resolution of monitor queries Prepare responses to SMV report data queries Subtask 1.2. Qualit