Sources Sought Notice.pdf

Sources Sought Notice No.: 75N92022Q0338 Title: NHLBI Clinical Research Monitoring Services

This is a Small Business Sources Sought notice for NHLBI Clinical Research Monitoring Services. This is NOT a solicitation for proposals or quotations. The purpose of this notice is to obtain information regarding:

(1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; 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.

An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

The National Heart, Lung, and Blood Institute (NHLBI) does not intend to award a contract based on responses nor otherwise pay for the preparation of any information submitted. As a result of this sources sought notice, the NHLBI may issue a request for quote (RFQ). However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this sources sought notice or the NHLBI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 541990 with a size standard 16.5 Million. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below and in the statement of work.

Background

The Division of Intramural Research (DIR) of the National Heart Lung and Blood Institute (NHLBI) possess 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 140 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 by DIR Principal Investigators.

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).

Purpose and Objectives

The primary objective of this acquisition is to provide comprehensive clinical research monitoring to the DIR clinical research program in accordance with standard operating procedures as required by the OCD and Federal law.

Contractor Requirements

See attached statement of work for specific requirements for these services.

Capability Statement and Information Sought

Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) single-sided pages (including all attachments) presented in single-space; using a 12-point font size minimum that clearly details the ability to provide the services outlined in the statement of work. The capability statements will be evaluated based on the contractor’s ability to provide the services that meets the specifications outlined in the attached statement work.

Capability statements must demonstrate the contractor’s ability to provide the services outlined in the statement of work which includes:

1) Total number of employees.

2) The professional of personnel as it relates to the requirements.

3) An outline of previous projects that are similar to this project requirements in which the organization and proposed personnel have participated, and

4) Any other information considered relevant to the program.

5) The respondents’ Unique Entity Identifier (UEI), organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code: 541990 with a small business size standard of 16.5 Million.

Closing Statement

All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address).

Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Nicole Freid, Contracting Specialist, at nicole.freid@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by April 22, 2022 at 5:00 PM, EST and must reference synopsis number 75N92022Q0338. All responses must be received by the specified due date and time to be considered.

Disclaimer and Important Notes mailto:nicolele.freid@nih.gov

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 provide the services. Respondents are advised that the Government is under no obligation to acknowledge receipt of 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/or solicitation may be published in the System for Award Management (betaSAM). 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).

STATEMENT OF WORK

1. INTRODUCTION/OVERVIEW

1.1. Project Title. Clinical Research Monitoring

1.2. Background. The Division of Intramural Research (DIR) of the National Heart Lung and

Blood Institute (NHLBI) possess 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 140 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 by DIR Principal Investigators.

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).

1.3. Purpose and Objectives. The primary objective of this acquisition is to provide comprehensive clinical research monitoring to the DIR clinical research program in accordance with standard operating procedures as required by the OCD and Federal law.

2. REQUIREMENTS

Independently, and not as an agent of the Government, Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government to perform the following work requirements:

2.1. Tasks. Under the direction of the OCD, Contractor shall provide comprehensive clinical research monitoring for the DIR’s clinical research program including but not limited to the following tasks:

2.1.1. Task 1. Clinical Research Monitors. Contractor shall employ a team of 6 fulltime, qualified Clinical Research Monitors (aka. Monitors) to meet the research monitoring needs of the DIR’s clinical research program. Under the direction of the OCD, Contractor shall assign Monitors to work on specific protocols, research areas, and/or research teams. Monitors shall exhibit the highest level of professionalism in their work and interactions with Federal government

SOW/Clinical Research Monitoring employees and other contractor staff. Monitors shall work collaboratively with clinical research staff to meet protocol objectives and further the DIR’s mission.

Under the direction of the OCD and in accordance with DIR standard operating procedures, Monitors shall be responsible for all monitoring activities for each protocol. Such activities include but are not limited to the following:

• Provide comprehensive research monitoring for single-site and multi-site clinical research protocols

• Develop comprehensive research monitoring plans for new protocols.

Regularly update plans for each protocol as needed.

• Plan, coordinate, and execute in-person visits to sites (i.e. site initiation visits, routine monitoring visits, and close-out visits)

• Assure adherence to International Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR)

• Assure compliance with institutional Standard Operating Procedures (SOPs) and policies, protocol requirements, and institutional reporting requirements

• Identify and inform Principal Investigators and protocol sponsors of concerns related to quality of protocol conduct. Provide concrete solutions to concerns/problems identified, and assist in the execution of such solutions.

• Perform regular Quality Control and Quality Assurance of clinical data uploaded to a variety of databases

• Assure study time points and regulatory reporting timelines are met

• Track trends in monitoring findings in order to identify potential global issues and work with OCD to educate clinical research staff accordingly

• Maintain awareness of all developments in the field of clinical research including application of new technologies by reading related literature, attending professional seminars, etc.

• Perform other tasks as assigned by OCD

2.1.2. Task 2. Contract-level Management. Contractor shall provide the following contract-level management services:

2.1.2.1. Subtask 2.1. Personnel Management. Contractor shall provide comprehensive supervision/management of the Monitors. Contractor shall take necessary steps to ensure Monitors 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 Monitors

• Provide on-going training to existing Monitors in Federal, agency, and DIR-specific standard operating procedures and policies pertaining to clinical research monitoring

• Make Monitor assignments according to the needs of specific protocols, research areas, and/or clinical research teams as directed by OCD

• Regularly observe Monitor 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 Monitor staff and provide recommendations to OCD

• Develop and execute retention plans for high performing Monitors

• Develop and execute robust performance improvement plans for underperforming Monitors

• Replace consistently underperforming staff with new, qualified staff as necessary

• Coordinate all Monitor travel

2.1.2.2. Subtask 2.2. Reporting to OCD. Contractor shall regularly account for all contract activities to the OCD. Contractor shall regularly report key business indictors to OCD during regularly scheduled, in-person meetings and provide ad-hoc reports as requested. Contractor shall work closely with OCD personnel and their partners to optimize DIR’s clinical research monitoring efforts. Contractor shall be forthcoming with issues involving Monitors and work collaboratively with the OCD to develop effective ways to address such issues.

2.1.2.3. Subtask 2.3. Hiring. Contractor shall manage the hiring and on-boarding of competent and professional Monitor staff. Contractor shall develop a hiring strategy that limits potential disruption of DIR clinical research activities resulting from turnover of Monitor 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 Monitor candidates.

2.1.2.4. Subtask 2.4. Standard Operating Procedures Management.

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

2.2. Key Personnel. The Clinical Research Monitor position provided by Contractor shall be considered Key Personnel; therefore, Contractor shall comply with Key Personnel requirements set forth elsewhere in the contract.

2.3. Reporting Requirements. Contractor shall communicate the status of all active projects to government personnel through a variety of means and frequencies.

Communication shall consist of both formal reports and more frequent, informal/ad-hoc communications with OCD personnel. Contractor shall prepare and submit the following reports in the manner stated below and in accordance with Section 2.4. Deliverables of this Statement of Work:

2.3.1. Monthly Progress Reports. This report shall summarize the activities and the progress made during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. A monthly progress report will not be required when the Annual Progress Report is due.

2.4. Deliverables. Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in Section 2.1. Tasks of this Statement of Work and upon delivery and acceptance by the Contracting Officer’s Representative (COR) of the following items in accordance with the stated delivery schedule:

2.4.1. The items specified below as described in Section 2.3. Reporting Requirements of this Statement of Work will be required to be delivered to the COR in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule 1 Monthly Progress Report 1 PDF copy emailed to

COR

Reports are due on or before seven (7) calendar days following the reporting period.

2.5. Assumptions. The work described in this Statement of Work is based on the following assumptions:

2.5.1. The DIR’s clinical protocol portfolio consists of more than 140 active Phase

0/I/II/III protocols. The number and type of protocols that Contractor will be required to support are subject to change throughout the period of performance.

Additionally, the specific needs of each protocol are subject to change. Therefore, Contractor shall work closely with the OCD to ensure Contractor’s resources are appropriately allocated across the DIR clinical research program.

2.5.2. The OCD will ensure adequate space is provided for Monitor staff to perform their assigned duties both on NIH main campus in Bethesda, MD and at partnering sites.

2.5.3. Some Monitors will be expected to regularly travel to other sites to perform research monitoring. Contractor shall be responsible for scheduling and booking transportation and other travel accommodations for its Monitors. Approved travel expenses will be reimbursed to Contractor as permitted by Federal Acquisition Regulation.

2.6. Government Furnished Property. The DIR shall supply Contractor with the necessary equipment to perform the tasks listed under Section 2.1.1. Task 1. Clinical Research Monitors. Contractor shall be responsible for obtaining any equipment/supplies not provided by the DIR.

2.7. Security Requirements.

2.7.1. Sensitive information. Some of Contractor’s personnel will have access to sensitive information such as personal identifiable information for patients.

Individuals with access to sensitive information will be required to sign non-disclosure agreements (NDAs). As a precaution, the government may at any time require other contractor personnel to sign NDAs.

2.7.2. Access to Federal IT Systems. Contractor will require regular access to Federal IT systems; therefore, Contractor shall comply with all Federal and agency safeguards and policies regarding use of Federal IT systems. The DIR will assist in obtaining access to Federal IT systems for Contractor personnel as needed.

2.7.3. Access to Federal Facilities. Contractor personnel will require regular access to

Federal Facilities; therefore, Contractor shall comply with all Federal and agency safeguards and policies regarding accessing Federal facilities. The DIR will assist in obtaining access to Federal facilities for Contractor personnel as needed.