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 conducts single and multi-site clinical research in sites located across the nation and in other countries. These are primarily 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 could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry-based studies, data science-based studies, or surveys.

The Contractor shall provide NIDA with a broad and flexible range of clinical trial administrative and research support and related services for the research conducted within the CTN. The work required under this contract includes:

1. Providing support for regulatory functions and requirements simultaneously for up to 36 on-going studies with as many as 40 study sites each including: 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 simultaneously for up to 36 on-going studies with as many as 40 study sites each including: 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.
3. Providing training to research staff simultaneously for up to 36 on-going studies with as many as 40 study sites each including: participating in the development and conduct of study orientation and study closeout meetings; developing and 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 simultaneously for up to 36 on-going studies with as many as 40 study sites each including: 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 simultaneously for up to 36 on-going studies with as many as 40 study sites each including: 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 simultaneously for up to 36 on-going studies with as many as 40 study sites each including: 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.

NIDA is requesting capability statements from 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) demonstrating their ability to perform the requirements described above. Capability statements should include any relevant experience as either prime or sub contractor performing work of a similar type and scale either for the government or in the private sector. Vendors are encouraged to provide a list of any relevant contracts they have performed that provided them with experience in performing the above tasks, including what their level of effort was for the performance. NIDA will evaluate the capability of vendors based on relevant experience in work of a similar type and scale, as well as any additional information provided by the vendor to demonstrate their capability.

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; 2) point of contact, 3) phone/fax/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.). 

Written capability statements must be SUBMITTED NO LATER THAN NOVEMBER 27, 2019 to the above Contracting Office Address, Attn: Tracy Cain. Electronic capability statements will be accepted by the primary point of contact.