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75N98026Q00536
Response Deadline
Jun 15, 2026, 7:00 PM(EDT)10 days
Eligibility
Contract Type
Sources Sought
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:
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:
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:
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:
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:
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: 1) the total number of employees; 2) the professional qualifications of technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including computer equipment and software; 4) an outline of previous projects that are similar to the project requirements in which the organization and proposed personnel have participated; and 5) 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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTES OF HEALTH NHLBI
NATIONAL INSTITUTES OF HEALTH NHLBI
6701 ROCKLEDGE DRIVE ROOM 6100
BETHESDA, MD, 20892
NAICS
All Other Professional, Scientific, and Technical Services
PSC
SUPPORT- PROFESSIONAL: OTHER