Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC)
Added: Dec 05, 2016 3:44 pm
This is not a Request for Proposals (RFP). This is a pre-solicitation announcement only. A request for proposals will be issued via FedBizOpps on or about December 21, 2016. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) is planning to award a ten (10) year cost reimbursement (plus fixed fee) option contract for a Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) responsible for providing the requisite personnel, facilities and services to support aspects of data collection, analysis and regulatory reporting for the pediatric clinical trials, and select preclinical data conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA). BPCA was initially authorized by Congress in 2002 and reauthorized in September 2007 and September 2012, to improve labeling information for drugs used to treat children. Further details will be provided in the RFP. This announcement is intended to inform interested offerors of the upcoming RFP. Included in this pre-solicitation are important background information and key requirements essential for responding to the RFP. This is a follow-on procurement to the award made to Emmes Corporation, Rockville, MD in 2009. BPCA Structure – NICHD has established a consortium of contractors to provide overall support for BPCA activities. This structure requires a high level of interaction among the various contractors and with NICHD. This structure, termed the BPCA Consortium, works together to construct, implement, monitor and report the clinical and preclinical activities within the BPCA to improve the knowledge and labeling of drugs, biologics and devices used in children. Communications and collaborations amongst all Consortium contractors occur through regular scheduled teleconferences, on-line activities, and face to face meetings. The Consortium consists of the following contracts in support of BPCA: BPCA Pediatric Trials Network (PTN) serves as the master contractor for the conduct of preclinical and clinical trial studies under BPCA. BPCA Data Coordinating Center (DCC) to manages and houses all of the data generated from the PTN, including leadership, tracking and submission of all U.S. Food and Drug Administration (FDA) regulatory documents generated under the BPCA Program. A major responsibility of the BPCA DCC will be to provide state of the art data capture, data sharing and assuring data quality in order to integrate the data from the clinical trials across dissimilar clinical specialties, and clinical sites. This also includes the integration of data from preclinical studies as well. The BPCA DCC’s primary responsibility will be to insure integrity of the data collected and the regulatory compliance with the FDA and NICHD policies on the conduct of clinical and preclinical studies. The activities conducted by the BPCA DCC will support data collection, data tracking, and data analysis and data storage for the generation and submission of all necessary reports to the FDA and to the NICHD Data Repository (DASH). The Contractor shall understand and perform and coordinate all of the regulatory responsibilities for NICHD including the submission of Investigational New Drug (IND) applications and New Drug Applications (NDA), as applicable, under the BPCA authorization. The regulatory requirements of BPCA also include assisting NICHD in tracking Proposed Pediatric Study Requests, submitting meeting requests along with meeting packages, and the submission of final data sets to the FDA Docket. The responsibilities of the BPCA-DCC will fall within the following categories: • Develop a Transition Plan for the following: (1) Archiving of data and trial master files for 20 closed studies; (2) continuance of regulatory, statistical and data management support for 25 ongoing BPCA clinical trials and; (3) continuance of regulatory, statistical, and data management support for approximately 25 additional new trials and activities during the performance of this contract. • Establish and manage a data collection, data analysis, and data storage system {in the form of de-identified datasets} that will support all pediatric clinical and preclinical activities under BPCA. The data from these activities will be placed into datasets, developed and maintained by the Contractor for submission to the FDA in the form of a Final study report and a public use dataset. • Provide leadership and support for all regulatory requirements associated with BPCA-related Investigational New Drug (IND) Applications and New Drug Applications (NDA or supplemental NDA), including coordination and management of all communications with FDA for clinical and preclinical trials and data. • Develop, coordinate, and maintain a BPCA Data Safety Monitoring Plan, to include the establishment and/or maintenance of the Data Safety Monitoring Board.• Provide clinical site monitoring, training and auditing necessary for protocol implementation and data quality review for all clinical and preclinical sites, estimating approximately 100 clinical sites for each contract year. • Provide Statistical leadership for the analysis of clinical trials data for submission to the FDA—includes interim analyses and analyses for final study report. • Participate in the Steering Committee of the BPCA Consortium and provide all logistics support for the Committee, including meetings and conference calls. A broad range of regulatory, information technology, statistical, clinical trial coordination and monitoring, and administrative expertise will be necessary to carry out the requirements of this solicitation. The Contractor shall be expected to demonstrate proven expertise in providing these requirements. I. Provide a description and documented evidence of the experience and expertise of the staff. Provide names of projects and references, noting those in support of submission of final clinical study data and datasets in a format suitable for submission to the FDA for drug studies, distinguishing previous experience from current projects. Response must include sufficient detail to demonstrate:a. Experience in organizing, managing and monitoring approximately 25 on-going pediatric clinical trials and approximately 25 additional new trials and activities at any given time, where each study may have up to 60 clinical study sites both domestic and international.b. Demonstrated capability and experience in performing all regulatory requirements for pediatric drug development domestically and internationally including; preclinical, Phases 1, and 2 clinical trials in the areas of pharmacokinetic, efficacy and safety trials in pediatrics. This includes the capability and experience in preparation and submission of IND and NDA applications and amendments required by the U.S. FDA and other international regulatory agencies, such as the European Medicines Agency (EMEA). c. Demonstrated capability to work in a consortium of contractors.d. Capability and experience in developing de-identified public use datasets that will inform the labeling of drugs used in children.e. Demonstrated capability and experience in simultaneously managing multiple clinical trials domestically and internationally. f. Capability and experience in providing statistical leadership in the development of clinical and preclinical protocols for submission to the FDA. This includes the capability in providing statistical expertise and the development of statistical analysis plans for all regulatory submissions of BPCA clinical trials. g. Capability and experience in training and certification for data coordinators of study sites.h. Demonstrated capability and experience in developing and implementing standard operating procedures that detail and delineate relationships and responsibilities between the multiple contractors in a network. i. Capability and experience in establishing and maintaining a communication system in compliance with FDA requirements for the submission of Serous Adverse and Adverse Event Reports.j. Capability in monitoring accuracy of adverse event reporting.k. Capability in establishing and supporting all of the activities of a Data Safety Monitoring Board. l. Capability in monitoring the accuracy, completeness and quality of data gathering, data entry, and data analysis.m. Capability in quality control procedures, including adherence to good clinical and laboratory practices, site audits, in-house data base audits and database validation.n. Capability and experience to assure that each clinical site has a current approved Federal Wide Assurance Number on file with the Office for Human Research Protection (OHRP). o. Capability to acquire and maintain a pharmacy program including the ability to ship, label, and monitor drug supply for ongoing clinical studies conducted under BPCA. p. Capability to acquire and maintain a specimen tracking system for ongoing clinical studies conducted under BPCA. q. Ability to provide logistical support to the Steering committees for teleconferences and meetings. II. Provide a description and documented evidence of the experience and expertise of the organizations Information Technology and Security capabilities. Response must include sufficient detail to demonstrate:a. Experience in establishing, administering, and supporting a state of the art, efficient, reliable, secure, and responsive systems for the collection, management, quality assurance and reporting of study data, b. Experience in establishing and supporting public use datasets that can operate under tiered access. c. Experience in establishing a system for electronic communication linkages among various stakeholders. d. Capability to develop computer programs, meeting NIH FISMA security requirements, that will support the data management, analyses, and storage for the clinical trials conducted under BPCA. This includes demonstrated capability in preparation of data and data analysis for the development of datasets that will be submitted to the FDA, published on the FDA docket, and public use datasets that can be used for peer reviewed publications, for example. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541711. Any questions concerning this announcement must be submitted in writing to Deborah Brock at Deborah.Brock@nih.gov or Alice Pagan at Alice.Pagan@nih.gov. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number for this announcement and any correspondence is: NIH-NICHD-OPPTB-2017-2. The RFP will be made available electronically only via the FedBizOpps website (http://www.fbo.gov). Offerors are responsible for routinely checking the FedBizOpps website for any possible solicitation amendments that may be issued.
NIH-NICHD-OPPTB-2017-2 Department of Health and Human Services National Institutes of Health
12/5/16, 3:44 PM