Transplantation Statistical & Clinical Coordinating Center (T-SCCC)

Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal 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; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses 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. Background Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical, translational, and clinical trial research efforts focusing on immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to evaluate the safety, effectiveness, and efficacy of therapeutic and preventive approaches; and investigational agents (e.g., pharmacologic, small molecule, tissue and biologic) to elucidate the underlying immunologic pathways and mechanisms of such approaches, interventions, and agents. A major thrust of DAIT studies include developing and evaluating surrogate/biomarkers of disease, clinical studies of natural history and genetic associations, and multi-omics approaches to: (i) allergic diseases and asthma; (ii) autoimmune disorders; and (ii) immune-mediated processes and pathology in solid organ, tissue and cell transplantation. This core clinical research portfolio is supported by clinical trials of related infectious disease diagnosis, treatment, prevention, and vaccine studies. Purpose and Objectives This request is for establishment of the Transplantation Statistical & Clinical Coordinating Center (T-SCCC) that will provide a broad range of support critical for the design, development, execution, analysis, and reporting of clinical research sponsored by NIAID in transplantation. The major clinical research programs supported by this solicitation include: Clinical Trials in Organ Transplantation (CTOT) and Clinical Trials in Organ Transplantation in Children (CTOT-C); in 2021 and thereafter, the Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA); the Immune Tolerance Network (ITN); investigator initiated clinical trials (IICT), and other clinical trial/study activities supported by NIAID herein collectively referred to as NIAID supported research. Project requirements The Contractor shall establish a Transplantation Statistical & Clinical Coordinating Center (T-SCCC) that will provide a broad range of support critical for the design, development, execution, implementation, analysis, and reporting of NIAID supported clinical research in the area of transplantation, cellular replacement and regenerative medical science. The breadth of transplantation clinical science spans clinical trials of all phases (including IND/IDE labelled) and observational and mechanistic studies addressing important epidemiologic, genetic/genomic, molecular, immunologic scientific questions related to organ and cellular transplantation. The scope of functions performed by the T-SCCC includes: clinical study protocol consultation and development, design, planning, and statistical analysis, preparation and distribution of assay kits for mechanistic studies (Study Start-up); study initiation and management, interim reporting to study team, the sponsor, NIAID-Transplant Data Safety and Monitoring Boards (DSMBs) and/or other regulatory oversight bodies, clinical safety and pharmcovigilance support, safety oversight, management of study collaboration portals, interim analyses, and bulk supply storage, kit-assembly, -labeling, -shipping and -distribution and biospecimen tracking in sites performing mechanistic studies and assays, and management of sample repositories (Study Conduct); data analysis, data reporting, presentation and abstract/poster/manuscript preparation, the final study report (Study Closeout). The statistical and clinical support functions currently being performed by Rho Federal Systems Division, Inc. (Rho), as described in RFA-AI-14-016 will be transitioned to the awardee of this contract. Currently, the clinical databases are managed through Medidata's cloud-based Rave Electronic Data Capture (EDC) software (https://www.medidata.com/en/audience/data-management/), while the safety database is managed thru Oracle Argus On-Premise Enterprise software (https://www.oracle.com/partners/en/products/applications/argus-applications/overview/index.html). Anticipated period of performance The initial 12-month base period of performance is expected to be from December 2021 to December 2022 with 4 subsequent 12-month term option years. Capability statement / information sought Interested respondents must submit a capability statement describing company's experience and ability to perform the requirements that includes the following: A summary list of similar work previously performed, The professional qualifications and specific experience of staff who may be assigned to the requirement, Resumes for proposed key personnel, including the Principal Investigator, that reflect Education, and previous work relevant to the proposed requirement, Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity, Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources, Demonstrated ability to carry out the requirements. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: DUNS. Company Name. Company Address. Company Point of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Maribel Miranda, Contracting Officer, at Maribel.Miranda@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID-SBSS-75N93020R00018. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00PM (Eastern Prevailing Time) on 07/03/2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).