DataFit Operation and Maintenance

 info@JohnSnowLabs.com © John Snow Labs, Inc. 2022  (302) 768-5227 Statement Work (SOW) 1. Background The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Additionally, the FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. The organization sponsoring and supporting this requirement is the Office of Computational Science (OCS) in the (super) Office of Translational Sciences (OTS) under the Center for Drug Evaluation and Research (CDER). The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs. The Office of Translational Sciences empowers a collaborative and high performing workforce to champion innovation and advance global human drug development. The vision of this super office is to drive advancements in human health through scientific and regulatory innovation. A summary of current work being done includes: • Promoting scientific collaboration and innovation in drug regulatory review across CDER • Assuring the validity of clinical trial design and analysis in regulatory decision making • Developing and applying quantitative and statistical approaches to decision making in regulatory review process • Ensuring alignment with CDER goals • Serving the CDER scientific community in establishing technology transfer agreements that are vital to collaboration with the broader scientific community • Maintaining knowledge management databases that can be the basis of improvements in the regulatory review process • Overseeing bioequivalence inspections to ensure the availability of safe and effective generic equivalents of investigational drugs The mission of the Office of Scientific Computing is to provide CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training. The focus of OCS’s current efforts include: • Building solutions that drive New Drug Modernization, promote access to quality data, and optimize data analysis capabilities • Processing Study Data for rapid use • Delivering effective tools, technologies, services, and training to meet CDER’s mission • Delivering solutions that streamline Bioresearch Monitoring (BIMO) workflow for reviewers and inspectors • Spearheading the CDER Innovation Board to harness subject matter expertise across FDA • Offering cloud-enabled innovation space for tools, technologies, and data exploration • Connecting CDER staff to the scientific computing resources and technology needed to drive efficient analysis and cost-effective solutions -- 1 of 28 --  info@JohnSnowLabs.com © John Snow Labs, Inc. 2022  (302) 768-5227 • Collaborating with industry, academia, and other external partners through our work with PHUSE, CDISC and BioCelerate Currently, the CDER process to identify submissions containing standard data is labor intensive: the Office of Business Informatics reviews all new submissions and performs an assessment on a few relevant files to determine if the submission appears to be SDTM (Study Data Tabulation Model) compliant. The DataFit system automatically and systematically checks submission and validates conformance of study data to CDISC Standards (e.g. SDTM, ADaM [Analysis Data Model], SEND [Standard for Exchange of Nonclinical Data]). This automated systematic approach will allow CDER to successfully transition to a more advanced regulatory process which takes full advantage of the benefits of high-quality standardized data improving the ability for Food and Drug Administration (FDA) reviewers to make science based regulatory decisions faster. 2. Project Scope The objective is to install, update, support, and develop enhancements and to maintain DataFit, the CDER’s data standards validation platform. DataFit supports multiple FDA needs for analyses of clinical trial data and non-clinical data and it integrates with existing systems to provide data standards validation. The scope includes all the activities necessary to support regulatory review operations, to maintain and provide enhancements to DataFit, which include necessary management functions such as Project Management, and Release Management. The majority of the DataFit capabilities are delivered through Pinnacle21 Enterprise, which is based on the open source CDISC clinical trial data standards compliance software and is licensed for use by FDA employees. DataFit extends the P21 Enterprise capability to functions unique to the FDA, such as implementing FDA business rules, FDA tools specific rules and interfacing with existing FDA systems. There is a need to have a platform that is flexible and can integrate and coordinate a variety of checking methods/procedures/programs in connection with a database. The scope includes: • Install/support/maintain DataFit by providing Steady State Activities described in SOW including software, interface, and configuration installation and updates in development, test and production environments. • Provide Pinnacle 21 enterprise license, or equal to solu…