The National Institute on Drug Abuse (NIDA) plans to solicit proposals from Offerors that can demonstrate the capability to act as a data, statistics, and clinical trial support center; providing data and clinical research support and resources in managing and carrying out multiple trials in drug abuse research. NIDA is seeking systems for data management, statistical support, document management and clinical trial services. The systems will be used to support clinical data capture, data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new drug abuse treatment interventions in order to further NIDA’s mission.

NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) conducts single and multi-site clinical trials through grants, contracts and cooperative agreements 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.  In support of efforts to address the national opioid public health crisis, the CTN plans a significant expansion of its opioid research portfolio.  Development and implementation of studies to improve access to high-quality addiction treatment, for example, by facilitating delivery of opioid use disorder treatment in general medical settings is expected.  These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys.

Although no actual clinical trials will be conducted under this requirement, the project activities will support NIDA trials in the following technical areas:

1. Establish and administer state-of-the-art, secured web-based systems for the collection, storage, management, quality assurance, and reporting of study data as well as systems to facilitate the collection and management of participant and site level electronic health records data.
2. Assist in the design and analysis of clinical trials, including the development of the statistical sections of protocols, study design, randomization and stratification methods, power and sample size calculations, interim monitoring and analysis plans, and data analytic plans.
3. Review and monitor the quality of study data including the development and management of a computerized data monitoring system that executes quality assurance and quality control procedures to evaluate accuracy, timeliness and completeness of data submitted by the clinical sites, including verification of the clinical and laboratory data used to determine that study participants have reached protocol-defined endpoints.
4. Monitor trial performance and progress and maintain a secure web-based clinical trial performance monitoring system to track key trial performance metrics (e.g. key dates, recruitment, availability of primary outcomes, missing data, etc.).
5. Coordinate meetings of study Data and Safety Monitoring Boards (DSMB) to include the preparation and presentation of reports on safety, data integrity, and site performance as well as coordination of meeting sites, materials, travel support, etc.).
6. Participate in relevant committee and subcommittee meetings including representation by the contract Principal Investigator on the CTN Steering Committee and representation by other senior data and statistical experts on other relevant CTN committees, subcommittees and workgroups.
7. Provide consultation, support services, and expertise in certain fields relating to study design and analysis, compiling and editing of clinical data, and other services related to clinical trials operations that might be required.

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years.  NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or options quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award.  NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds.  Various task orders will be issued to support distinct tasks and studies which will separately support the CTN and the NIH launched HEAL (Helping to End Addiction Long-term) Initiative.

RFP No. 75N95022R00009 will be available electronically on or about December 1, 2021. Interested Vendors will be able to access the RFP through the www.SAM.gov or through the NIDA website: (URL: https://www.drugabuse.gov/funding/nida-office-acquisitions-contracting#Find). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.