Sources Sought Notice.pdf

CLINICAL RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS)

75N93022R00040

Sources Sought Reference Number: 75N93022R00040

Type of Requirement

New Requirement Follow-on Other (specify): The purpose of the planned CROMS RFP is to recompete the current

Clinical Research Operations and Management Support research contract in place whose period of performance ends in April 2024).

Place of Performance Place of performance is unknown at this time Place of performance is known. Address or general location: _______________

Recompetition (if applicable)

HHSN272201700007C

Technical Resources International, Inc.

6500 Rock Spring Drive #650 Bethesda, MD 20817

(301) 564-6400

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Sources Sought Notice Information

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, 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.

Background Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, including research to counter bioterrorism. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

The evaluation of therapeutics, vaccines, devices, diagnostics and treatment strategies in clinical trials and studies is an essential element of the efforts of NIAID. Through multiple grant and contract research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 1-4 clinical trials; surveillance or natural history / cohort studies;

evaluation of novel diagnostic devices or product delivery systems; new vaccine formulations, schedules and modes of delivery; evaluation of safety and efficacy of vaccines and therapeutics against emerging infectious diseases, including NIAID Category A, B and C priority pathogens;

and studies of critical public health needs for emerging and re-emerging infectious diseases. The NIAID DMID Office of Clinical Research Affairs (OCRA) provides resources and services in support of clinical research to DMID and DMID-supported investigators and fulfills DMID’s regulatory obligations for clinical research oversight through a contract for clinical research operations and management support services: Clinical Research Operations and Management Support (CROMS).

For nearly two decades, CROMS has supported DMID’s efforts in clinical research including:

In September 2003 NIAID awarded a seven-year contract to PPD Development, LP (contract number: N01-AI-30068) to provide clinical trials management support services to NIAID and NIAID-supported investigators.

The contract was recompeted and awarded in April 2010 to Technical Resources International, Inc. (contract number: HHSN272201000019C) as DMID Clinical Research Operations and Management Support (CROMS) for one base year, plus six option years thus ending in 2017.

The contract was recompeted and awarded in April 2017 to Technical Resources International, Inc. (contract number: HHSN272201700007C) as DMID Clinical Research Operations and Management Support (CROMS) for one base year, plus six option years ending in 2024.

This sources sought notice provides for the re-competition of these support activities to be continued under the resultant award.

Purpose and Objectives

• Provides resources and services in support of clinical research to DMID and DMID-supported investigators

• Fulfill DMID regulatory obligations for clinical research oversight

Project requirements Contractors will support both DMID and clinical sites with:

– Risk assessment and mitigation

– Site monitoring

– Safety monitoring / pharmacovigilance

– Safety oversight committees

– Human Subjects protection

– Regulatory document management

– Quality management

– Training

– Medical Writing

– Data systems and analytics

Anticipated period of performance The Government anticipates making one award. It is anticipated that the duration of the level-of-effort contract will be a one-year contract with options for six (6) additional years.

Capability statement/information sought In order to respond to this notice, contractors must be able to clearly convey their experience and/or ability to perform the following tasks identified:

a. Safety monitoring, including proposed safety reporting systems, tracking and handling of serious adverse events (SAEs);

b. Safety Oversight structures, including safety committee member support and safety committee documentation;

c. Planning and conduct of clinical site monitoring and reporting;

d. Planning and conduct of pre-study activities, including clinical site assessments; clinical site

Quality Management planning and consultation; and receipt, assessment and maintenance of essential regulatory documentation;

e. Medical writing services, including the development of clinical protocols and protocol-related documents, and technical writing;

f. Maintenance of a website and centralized data system to track protocol information (e.g., project title, Principal Investigator, status, accrual), and clinical support service activities, including SAE data and reporting; quality management activities; protocol development activities; and site essential documentation activities;

g. Data management and data analytics;

h. Development and implementation of an internal Quality Assurance and Quality Control plan to ensure adherence to standard operating procedures;

i. Development and implementation of training programs for clinical site personnel regarding the conduct of clinical trials; and

j. The ability to expand staffing during any contract year if Options to increase level-of- effort are exercised as directed by NIAID/DMID.

Assume that:

1. On the effective date of the contract 200 clinical trials will be active or in development.

2. Clinical trials to be supported will be performed in both domestic and foreign locales.

3. Forty-five (45) new clinical trials, with an average enrollment of 100 participants per trial, will be initiated in each year of the contract period of performance.

In addition, contractors must be able to provide a total level of effort of 81.66 FTEs per year (169,853 total hours per year based on a Work Year of 2,080 hours) for a period of performance of seven years (Base period plus six, one-year Options). In any year of the contract, contractors must also be able to respond to requests to expend increased effort based on the exercise of Options in increments of 2 FTEs, 5 FTEs, 8 FTEs or 15 FTEs (maximum of 90 FTEs per year using any combination of Options 7, 8, 9 or 10) to provide additional, unplanned clinical trial support needs to NIAID that may be required in response to emerging needs or public health emergencies, which will result in a total possible yearly maximum of 171.66 FTEs.

Contractors must provide expertise in the following or equivalent areas:

Professional Support: Principal Investigator, Project Directors/Managers, Quality Assurance and Quality Control, Clinical Site Quality Management Programs, Clinical Site Monitors, Site Essential Regulatory Documentation, Training, Medical Writing, Safety Oversight structures and Safety Reporting, Human Subject Protections Technicians and Support: Information Technologies/Data Systems Development and Management, Web Services, Records Coordination, Data Analytics Non-Professional Support: Clinical Site Monitoring Support, and Meeting Support

Base Period plus Options to Increase Term with Suggested Labor Mix to Fulfill SOW

Objectives

Labor Category

Base Year 1 (12 months)

Option 1 Year 2 (12 months)

Option 2 Year 3 (12 months)

Option 3 Year 4 (12 months)

Option 4 Year 5 (12 months)

Option 5 Year 6 (12 months)

Option 6 Year 7 (12 months)

Professional 59% 59% 59% 59% 59% 59% 59%

Technical 31% 31% 31% 31% 31% 31% 31%

Support 10% 10% 10% 10% 10% 10% 10%

Total 100% (169,853 hours)

100% (169,853 hours)

100% (169,853 hours)

100% (169,853 hours)

100% (169,853 hours)

100% (169,853 hours)

100% (169,853 hours)

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 7 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one inch on each edge of the paper. Print setup should be single sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.

Required Business Information:

• UEI

• Company Name.

• Company Address.

• Company Point of Contact, Phone and Email address

• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.

• Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://sam.gov/content/home. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electric copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Michael Welsh, Contracting Officer, at welshmi@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The email subject line must specify 75N93022R00040. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 4:00 PM (Eastern Prevailing Time) on 12/2/2022. CAPABILITY STATEMENTS RECEIVED AFTER THIS

DATE AND TIME WILL NOT BE CONSIDERED.

Disclaimer and Important Notes 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 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 a review of the responses received, a pre-solicitation synopsis and solicitation may be published at SAM.gov. 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).”

https://sam.gov/content/home