CTN Data, Statistics, and Clinical Trial Support Center (DSC7)

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal of abstracts or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses); (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) whether commercials sources and services are available in the marketplace. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code 541715 should not submit a response to this notice. This notice is issued to help determine the appropriate acquisition method including small business socioeconomic set aside possibilities and to determine the availability of commercial or non-commercial companies technically capable of meeting the Government's potential requirement. It is not construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Furthermore, it should be noted that any future solicitations that may be issued as a result of this notice, or in response to this requirement, may be issued using a different solicitation number from the one identified above. Background The National Institute on Drug Abuse (NIDA) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA’s mission is to advance science on drug use and addiction and to apply that knowledge to improve individual and public health through: 1) strategically supporting and conducting basic, clinical, and epidemiological research on drug use, its consequences, and the underlying neurobiological, behavioral, and social mechanisms involved; and 2) advancing the translation, effective implementation, and dissemination of scientific research findings to improve the prevention and treatment of SUDs, reduce adverse health consequences associated with drug use, and enhance public awareness of addiction as a chronic but treatable medical illness. NIDA’s Clinical Trials Network (CTN) was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide. 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://nida.nih.gov/organization/center-clinical-trials-network-cctn/clinical-trials-network-ctn. Requirement NIDA is seeking capability statements from small businesses having the capability to act as a data, statistics, and clinical trial service center; providing data and clinical research services and resources in managing and carrying out approximately 20 independent trials in drug use and addiction research at any given time. NIDA requires vendors capable of providing systems for data management, statistical analysis, document management and clinical trial services. The data systems will be used to manage and implement clinical data capture, data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new substance use disorder treatment medications and interventions in order to further NIDA’s mission. NIDA 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. 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 be integrated and central to NIDA trials in the following areas: 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. 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. 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. 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.). 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. 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. Provide consultation, data analytical 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. Instructions: The established NAICS code is 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 of 1,000 employees or fewer. Interested small business organizations shall demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: Work Experience: Capable Vendors must demonstrate the capability and experience to act as a data, statistics, and clinical trial service center; providing data and clinical research services and resources in managing and carrying out approximately 20 independent trials in drug use and addiction research at any given time. NIDA requires vendors capable of providing systems for data management, statistical analysis, document management and clinical trial services. The data systems will be used to manage and implement clinical data capture, data analysis, information exchange, scientific discovery efforts and clinical evaluation of promising new substance use disorder treatment medications and interventions in order to further NIDA’s mission. Organizational Experience: Capable Vendors should describe previous similar projects in the area(s) specified above and where the work was of a similar size and scope. In the response be sure to indicate if you were the prime contractor or a subcontractor. If a subcontractor, be sure to identify your roles and responsibilities as the subcontractor; what percentage of work your subcontract was responsible for; and identify the prime contractor. Personnel: Capable Vendors should identify personnel with the appropriate education, credentials, training, qualifications, experience, and competence to carry out the projects and the tasks identified above. Knowledge and experience in this field of work is critical, and the overall work efforts should be led by professionals who have earned a doctorate degree in a related field of study. Individual efforts and tasks should be led by professionals who have earned a master’s degrees in a related field of study. Basic credentials for proposed personnel will require experience in clinical trials management, biostatistics, drug use and addiction research, data management, statistics. Capable Offerors shall demonstrate how they have staffed similar key personnel on other contracts. Facilities: Capable Vendors should describe the physical space (e.g. offices, meeting rooms, server room, etc.) necessary to accommodate the required staff and equipment as well as the necessary mechanical systems (e.g. HVAC, fire suppression, redundant power, etc.); IT systems and hardware necessary to support the work including sufficient internet access, electronic data collection systems for study data, in-house or cloud based servers for storage of study data, and business software such as the MS Office suite; and security measures including physical and IT access controls, system monitoring, data backup processes, and firewalls. Interested Offerors should describe their facilities or demonstrate its ability to obtain the facilities necessary to support the requirements discussed above. The Government will assess the appropriateness of the responses based on the described work experience, organizational experience, personnel, and facilities described in the capability statement. If the Vendor proposes to team with another organization, please be sure to include the capabilities of any potential proposed partners. The Government will consider any other specific and relevant information about this procurement that would improve our consideration and assessment of the information presented. Documentation may include, but not be limited to, contracts both Government and comm