SSN.pdf

Document Type: Source Sought Notice

Solicitation No.: 75N95023R00078 (ref # N01DA-24-2251)

Project Title: Clinical Coordinating Center for NIDA’s Clinical Trials Network

Classification Code: A – Research & Development

NAICS Code: 541715 – Research and Development in Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

Description

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having capability to provide resources to support multiple and simultaneously-running multi-site clinical trials conducted in the National Drug Abuse Treatment Clinical Trials Networks (CTN).

NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) was established in 1999 to bridge the gap between research and practice to improve substance use disorder (SUD) treatment. Through the collaborative partnership of scientists, treatment providers, and other community stakeholders, the CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. Over the last two decades, the CTN’s research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements. The CTN has been engaging providers in general medical settings and healthcare systems, and in 2015 the Network built upon and expanded its research portfolio encouraging adoption of innovative bioinformatics approaches, new technology, and "learning healthcare system" principles to enhance the efficiency of SUD clinical research and clinical care.

The CTN conducts clinical trials in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients. These studies are typically Phase III clinical trials, but can also include Phase I, Phase II, Phase IV, and/or registry trials or surveys. More information on the CTN and the CTN’s research portfolio is available at https://www.drugabuse.gov/about-nida/organization/cctn/ctn.

The purpose of this contract is to provide a wide range of support services to aid NIDA in its goal of establishing and operating NIDA’s Clinical Trials Network. The range of support services required under this contract includes:

1) Providing support for regulatory functions and requirements – advising on IRB submissions, human subject protection assurances, and compliance with applicable federal regulations; establishing an online regulatory document repository; preparing and submitting Investigational New Drug Applications (IND); consulting on regulatory issues raised by the NIDA, study review boards, and study staff regarding safety and AE/SAE reporting; etc.

2) Reviewing and monitoring protocol implementation – administering a program of quality assurance visits to monitor study-related functions and implementation of trials; assessing adherence to and compliance with all procedures specified by the protocol; assessing the quality of research data; etc.

https://www.drugabuse.gov/about-nida/organization/cctn/ctn https://www.drugabuse.gov/about-nida/organization/cctn/ctn

3) Providing training to research staff – participating in the development and conduct of study orientation and study closeout meetings; providing training on clinical research conduct (e.g.

Good Clinical Practice, Adverse Event/ Serious Adverse Event reporting; protection of human subjects, etc.); tracking required training of study staff; etc.

4) Providing pharmaceutical services and clinical research support – purchasing of required study medications and study products; managing the receipt, packaging, storage and distribution of study materials; obtaining necessary regulatory approval for handling both controlled and non-controlled substances; providing other clinical support such as ECG consultation, etc.

5) Providing drug testing and analytical laboratory services – acquiring and distributing on-site testing devices; coordinating central lab services; monitoring performance and validity of lab tests and services; etc.

6) Providing support for protocol development – participating in protocol meetings and contributing to the development of protocol-related documents such as quality assurance plans, data and safety monitoring plans, DSMB reports, study operation manuals, etc.

7) Participating in CTN committee and subcommittee meetings and conference calls.

8) Providing other expert consultation and support services as needed.

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. All capability statements must provide the following: 1) company name and address, UEI number; 2) point of contact, 3) phone/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.).

Electronic capability statements must be SUBMITTED NO LATER THAN SEPTEMBER 15, 2023, to the following POCs:

Points of Contact

Primary Point of Contact:

Polina Klimenkova Contract Specialist polina.klimenkova@nih.gov

Secondary Point of Contact:

Josh Lazarus Contracting Officer josh.lazarus@nih.gov mailto:polina.klimenkova@nih.gov mailto:josh.lazarus@nih.gov