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. Quality Assurance/Quality Control. Under the direction of the OCD and in accordance with DIR standard procedures, CDMs shall perform various Quality Assurance (QA) and Quality Control (QC) activities for each protocol. CDMs shall adhere to the QA/QC plan developed by Contractor and approved by the OCD (see Section 2.3.4. Quality Assurance/Quality Control Plan). QA/QC activities shall include but not be limited to the following: Provide data management processes overview to new clinical teams Conduct three-step CDM QC process (i.e. Self QC, Peer QC, and Supervisor QC) Coordinate with clinical research team to ensure timeliness of data reporting and compliance with the protocol Subtask 1.3. CIBMTR Data Management. Under the direction of the OCD and in accordance with DIR standard procedures, CDMs shall perform various data management activities for transplant-related protocols as required by the Center for International Blood & Marrow Transplant Research (CIBMTR). These activities include but are not limited to the following: Collect transplant data Reconcile transplant data discrepancies Perform data abstraction/entry and submission to the CIBMTR Coordinate activities in various transplant groups to ensure compliance with Continuous Process Improvement (CPI) timelines Assist with development of source document templates Provide CIBMTR data training to new clinical research team members Subtask 1.4. Database-related Activities. Under the direction of the OCD and in accordance with DIR standard procedures, CDMs shall perform various database-related activities including but not limited to: Enter data into databases specific to each protocol Assist with eCRF development Assist with the development and maintenance of clinical databases including but not limited to NIH s CTDB and other sponsor databases Assist with database user acceptance testing Coordinate activities related to active database support (i.e. amendments, technical updates, etc.) Subtask 1.5. Other Duties as Assigned. CDMs shall be considered Integrated members of the clinical research teams to which they have been assigned. As such, CDMs shall contribute responsive and tailored services to the team dynamic and/or clinical study and assist team members with other duties as needed in order to meet team objectives. Task 2. Contract-level Management. Contractor shall provide the following contract-level management services: Subtask 2.1. Personnel Management. Contractor shall provide comprehensive supervision/management of the CDMs. Contractor shall take necessary steps to ensure CDMs consistently perform at a high level and work effectively with the DIR s clinical/administrative/scientific network of Federal employees, contractors, special volunteers and industry partners. Contractor shall perform all supervisory/management duties in accordance with the approved Personnel Management Plan (see Section 2.3.3. Personnel Management Plan). Supervisory/management duties shall include but not be limited to the following activities: Plan and execute a comprehensive orientation program for new CDMs Provide on-going training to existing CDMs in Federal, agency, and DIR-specific standard operating procedures and policies pertaining to clinical data management Make CDM assignments according to the needs of specific protocols, research areas, and/or clinical research teams as directed by OCD Oversee execution of QA/QC Plan (see Section 2.3.4. Quality Assurance/Quality Control Plan) Closely monitor CDM performance through the establishment and regular assessment of key metrics/business indicators Obtain customer feedback from OCD and clinical research teams Regularly assess metrics data and customer feedback to support informed decisions regarding CDM staff and provide recommendations to OCD Develop and execute retention plans for high performing CDMs Develop and execute robust performance improvement plans for underperforming CDMs Replace consistently underperforming staff with new, qualified staff as necessary Coordinate all CDM…