Pre-Sol_Notice-CROMS.pdf

PRESOLICITATION NOTICE

NIAID DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES: CLINICAL

RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS)

RFP NIAID-DMID-NIHAI2015043

Type of Requirement

New Requirement Follow-on (Contract No.: HHSN272201000019C) Other (specify):________________

Place of Performance

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

Recompetition

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, Room 3B44, MSC9821, For USPS mail, use: Bethesda, MD 20892-9821 For FedEx, UPS and other courier services, use Rockville, MD 20852

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 options—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 three for each contract year (with each of the three 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 26 FTEs above the base quantity of 101.60 FTEs per year (for a yearly maximum of 127.60 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 follow-on 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

Anticipated award date: January 3, 2017

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 other than HIV, 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 extensive network of grant and contract research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 1-4 clinical trials in people of all ages and risk categories. NIAID supports targeted surveillance for pathogens of interest; evaluations of novel product delivery systems; reevaluation of vaccine formulations, schedules and modes of delivery; evaluation of safety and efficacy of vaccines and therapeutics against NIAID Emerging Infectious Diseases, including NIAID Category A, B and C priority pathogens; and studies of critical public health needs and opportunities for emerging and re-emerging infectious diseases.

The purpose of the NIAID DMID Clinical Research Operations and Management Support program is to provide clinical trials management support services to DMID and DMID-supported investigators. Activities include a web-based clinical trials management system;

clinical site assessment, preparation and monitoring; and centralized safety monitoring and document management.

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

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.

http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx 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. protocol development support services, including the development of clinical protocols and protocol-related documents;

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; and

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

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 January 3, 2017. It is estimated that 101.60 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 December 2, 2015, and may be accessed through FedBizOpps http://www.fedbizopps.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 via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. 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."

http://www.fedbizopps.gov/ https://ecps.nih.gov/