Presolicitation Notice.pdf

PRESOLICITATION NOTICE

NIAID DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES:

CLINICAL RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS)

75N93022R00040

Type of Requirement

New Requirement

Follow-on

Other (specify): The Recompetition of the current Clinical Research Operations and Management Support (CROMS) contract, scheduled to end in April 2024

Place of Performance

Place of performance is unknown at this time

Place of performance is known. Address or general location: __________________

Recompetition

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 Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821

Duration of contract:

Base Period of one (1) year + Six (6) one-year options to extend the contract term for a maximum period of performance of seven (7) years.

If Options will be included, describe Options:

Four types of options will be included: severable term, severable quantity, non-severable, and the Option to Extend Services under FAR 17.208(f). Term option —of which there will be six—will provide NIAID with the right to extend the period of performance by one year, while quantity options—of which there will be four for each contract year (with each of the four options capable of being exercised multiple times during any contract year), will provide NIAID with the right to purchase Levels of Effort of up to 90 FTEs above the base quantity of 81.66 FTEs per year (for a yearly maximum of 171.66 FTEs). One non-severable option will account for the additional, short-term effort that will be needed at the beginning of the contract to transition to the new contractor should this contract not be awarded to the incumbent. Similarly, one non-severable option will account for the additional, short-term effort that will be needed at the end of the contract should a recompeted contract not be awarded to the successful offeror of the current solicitation. Finally, the Government will, under FAR 17.208(f), reserve the right to extend services—whether one time or on multiple occasions (whatever unexpected circumstances might deem necessary)—for no more than a total of six additional months over the life of the contract.1 1 See FAR 17.208(f) and 52.217-8. This option provision may be exercised more than once, but the total extension of performance shall not exceed 6 months.

Anticipated award date: April 12, 2024

Presolicitation Notice Information

Introduction

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases has a requirement for the provision of clinical trials management support services.

Description

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 an 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 presolicitation notice provides for the re-competition of these support activities to be continued under the resultant award.

Offerors should have the qualifications and experience, and capability to perform this requirement for more than 200 active clinical trials at both domestic and foreign sites, with particular attention to the appropriateness and adequacy of organizational experience, proposed plans and procedures, availability of personnel, and understanding of problems and deficiencies for a variety of clinical trial support functions, including:

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.

It is anticipated that one (1) Cost-Reimbursement, Level-of-Effort type contract will be awarded for a one-year Base Period and six (6) Term Options with the period of performance beginning on or about April 12, 2024. It is estimated that 81.66 Full-Time Equivalents (FTEs; based upon a work year of 2,080 hours) including subcontractor and consultant personnel, will be required. If the offeror’s work year is less than the 2,080 hours, the offeror must understand that the requirement is for the Contractor to provide the exact number of hours required per year for its proposal to be considered responsive.

This information is furnished to offerors for information purposes only and is not to be considered restrictive for proposal purposes.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about March 15, 2023, and may be accessed through SAM.gov. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."

https://sam.gov/content/opportunities https://ecps.nih.gov/