A-- Data Coordinating Center for BPCA - Data Coordinating Center ( DCC) to provide clinical data management, statistical analysis, regulatory support, and data quality oversight for pediatric clinical trials conducted under the BPCA program to support FDA regulatory submissions and pediatri
AI helper
This is a Sources Sought notice for market research purposes only, not a solicitation. The National Institute of Child Health and Human Development (NICHD) is seeking information on the capabilities of small businesses to provide Data Coordinating Center (DCC) services for the Best Pharmaceuticals for Children Act (BPCA) program. These services include clinical data management, statistical analysis, regulatory support, and data quality oversight for pediatric clinical trials to support FDA regulatory submissions and pediatric drug development research. The North American Industry Classification System (NAICS) code is **** with a size standard of 1,000 employees or less. Responses should detail experience in managing concurrent pediatric clinical trials, regulatory support for pediatric drug development, working in a consortium, developing de-identified public use datasets, statistical leadership, training, standard operating procedures, communication systems for adverse event reporting, data safety monitoring boards, quality control, federal wide assurance, pharmacy programs, specimen tracking, and logistical support. Information technology and security capabilities are also requested. Responses are due by March 31, 2026, 4:00 PM EDT, and should be submitted electronically to ***@***. *. * and ***@***. *. * response should not exceed 15 pages, single-spaced, with 11-point font or greater, excluding resumes. Proprietary, classified, confidential, or sensitive information should not be included.
The responses to this notice are due no later than March 31, 2026, 4:00 PM EDT.
The bid notice requires small businesses to provide a description and documented evidence of their staff's experience and expertise, including project names and references, particularly those supporting the submission of final clinical study data and datasets to the FDA for drug studies. Specific areas of experience include managing concurrent pediatric clinical trials, regulatory support for pediatric drug development, working in a consortium, developing de-identified public use datasets, statistical leadership, training, standard operating procedures, communication systems for adverse event reporting, data safety monitoring boards, quality control, federal wide assurance, pharmacy programs, specimen tracking, and logistical support. Additionally, organizations must demonstrate experience in establishing, administering, and supporting IT and security capabilities for data collection, management, quality assurance, and reporting.
