CTN Data, Statistics, and Clinical Trial Support Center (DSC5)

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); and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. 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 should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. 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. Requirement: The National Institute on Drug Abuse (NIDA) is seeking capability statements from small businesses having 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. We are 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 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 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. 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 1) Experience: An outline of previous similar projects in the area(s) specified above and work in the field of drug abuse. 2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions. 3) Facilities: Availability and description of facilities and equipment required to conduct the type of work required under a specific task area. The Government will assess the appropriateness of professional and technical personnel classifications. The Government will consider any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform under these task areas. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. 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. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received to provide feedback to respondents with respect to any information submitted. All capability statements must provide the following: 1) company name, address; and DUNS number; 2) point of contact; 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) the capability information in response to the requirement and qualification identified in this notice; and; 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN NOVEMBER 02, 2018 at 4:30 EST to the primary point of contact. The Subject line for the submission should include this Small Business Sources Sought Number.