SAM #75N98026Q00536

Clinical Data Management Support Services for NIH NHLBI DIR

This opportunity is for small businesses to provide clinical data management support services to the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research (DIR). - Government Buyer: - Department of Health and Human Services - National Institutes of Health (NIH) - National Heart, Lung, and Blood Institute (NHLBI) - Office of Acquisition and Logistics Management (OALM), Research and Development and Professional Services Division B - Vendors/OEMs: - No specific OEMs or vendors are named; this is a services-only requirement - Services Requested: - Provision of 20 full-time Clinical Data Managers (CDMs) to support over 160 active clinical research protocols - Comprehensive data management functions including: - Research data entry - Protocol-specific data management - Adverse event grading - Audit preparation - Database support and management - Quality assurance/control - CIBMTR data management - Personnel management, hiring, and training - SOP management and maintenance - Contract phase-in/phase-out services - Communication planning and reporting - Unique/Notable Requirements: - Contractor must supply a dedicated team of 20 CDMs - Services must comply with Federal law and standard operating procedures - Support for a large volume of clinical protocols (over 160) - Emphasis on personnel management, SOP maintenance, and communication - NAICS code 541990 (All Other Professional, Scientific, and Technical Services) - No products are being procured; this is strictly a services contract - Anticipated contract duration is one base year plus four option years (total five years)

Description

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: The availability and capability of qualified small business sources; Whether small businesses are classified as HUBZone, service-disabled, veteran-owned, 8(a), veteran-owned, woman-owned, or small disadvantaged; and 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 travel

Subtask 2.2. Reporting to OCD. Contractor shall account for all contract-related activities to OCD. Contractor shall report key business indicators to OCD during regularly scheduled, in-person meetings and provide ad-hoc reports as requested. Contractor shall work closely with OCD and its partners to optimize DIR’s clinical data management efforts. Contractor shall be forthcoming with issues involving CDMs and work collaboratively with OCD to develop effective ways to address such issues.

Subtask 2.3. Hiring. Contractor shall manage the hiring and on-boarding of competent and professional CDM staff. Contractor shall develop a hiring strategy that minimizes any potential disruption of DIR clinical research activities resulting from turnover of CDM staff. Vacancies caused by departing staff shall be filled within 30 calendar days of staff departure. Upon request by OCD, Contractor shall provide OCD the opportunity to participate in the vetting and/or interviewing of CDM candidates.

Subtask 2.4. Standard Operating Procedures Management. Contractor shall be responsible for the development and regular maintenance of OCD’s clinical data management Standard Operating Procedures (SOPs) document repository. Contractor shall ensure all clinical data management SOPs are accurately and clearly documented in PDF format and stored in a shared location determined by OCD. All new SOPs and changes to existing SOPs must receive approval from OCD prior to implementation. Contractor shall be responsible for ensuring CDMs learn and comply with all relevant SOPs.

Subtask 2.5. Contract Phase-in Services. Phase-in services are required to ensure minimum disruption to vital government business and must be completed within 30 calendar days after award. Upon completion of the phase-in period, Contractor shall be fully staffed and prepared to begin full performance under the requirements set forth in this Statement of Work. Contractor shall ensure that there will be no service degradation during phase-in. Contractor shall provide a final version of a phase-in plan no later than seven (7) days after contract award and shall regularly update OCD on the status of phase-in activities during the phase-in period (see Section 2.3.1. Phase-in Plan).

Subtask 2.6. Contract Phase-out Services. Contractor shall complete a phase-out plan which facilitates the accomplishment of a seamless transition from the incumbent to an incoming contractor/government personnel at the expiration of the contract. Contractor shall provide a phase-out plan no later than 90 calendar days prior to expiration of the contract (see Section 2.3.2. Phase-out Plan).

Subtask 2.7. Communication Plan. Contractor shall ensure clear, concise, and routine communication between the COR, PCC Program Manager, and OCD personnel. Contractor shall provide a written communication plan which outlines a communication strategy to demonstrate a comprehensive clinical data management program in accordance with the SOW. The Contractor shall address formal and informal communication techniques and approaches. The communication plan will serve as a guide for all contract stakeholders to adhere to a strategy which reduces disruption and lost productivity due to poor communication.

Anticipated Period of Performance The Government intends to negotiate one (1) contract award, for the potential period of one (1) base year and four (4) option year(s) for a total of five (5) years.

Capability Statements – How to submit a response Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capability statements must specifically address each project requirement separately. Additionally, the Capability Statement should include: The total number of employees; The professional qualifications of technical personnel as it relates to the above outlined requirements; A description of general and specific facilities and equipment available, including computer equipment and software; An outline of previous projects that are similar to the project requirements in which the organization and proposed personnel have participated; Any other information considered relevant to this program. The Capability Statement must not exceed 15 single-sided or 7.5 double-sided pages in length and use a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The Government requests that no proprietary or confidential business data be submitted in response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability Statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability Statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the Sources Sought Notice number 75N98026Q00536.

Point of Contact John Lear, Contracting Officer, Research and Development (R&D) NHLBI Branch, R&D and Professional Services – Division B, Office of Acquisition and Logistics Management (OALM), Office of the Director, NIH; Phone: (301) 827-7716; E-mail: john.lear@nih.gov Department of Health and Human Services, National Institutes of Health, Office of Acquisition and Logistics Management (OALM), Research and Development and Professional Services – Division B, 6701 Rockledge Drive, RKL2, Bethesda, MD 20817 UNITED STATES.

Information Submission Instructions Interested parties shall submit capability statements via electronic mail and must reference the Sources Sought Notice number 75N98026Q00536 in the subject line of the e-mail submission. The due date for receipt of capability statements is 3:00 p.m. Eastern Standard Time (EST) on June 15, 2026. All responses must be received by the specified due date and time in order to be considered. Capability statements shall be submitted electronically to the designated Contracting Officer as follows: John Lear, Contracting Officer: john.lear@nih.gov This notice does not obligate the Government to award a contract(s) or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

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