“The FDA OBI is seeking information from commercial industry on capabilities related to applying health and life science innovation, digital health, artificial intelligence, advanced analytics, statistical process control, application pattern recognition, and risk categorization.”
“FDA anticipates establishing a BPA vehicle in FY 2020, within the estimated ceiling amount of $100M, to acquire Health and Life Science Innovation, Technology Modernization, Digital Health Capabilities (e.g. Blockchain/Alternative Technology), Advanced Data Analytics, Artificial Intelligence, Systems Engineering, Risk Management, and Regulatory Drug Oversight Services to potentially design, develop, maintain, and enhance existing and future FDA CDER systems in the draft task areas…”
“The contractor shall demonstrate and state their abilities to perform the following:
2. Develop a study design and plan, applying principles and methods that include, but are not limited to: advanced statistical methods, including both Classical and Bayesian statistics, statistical process control, operations research, risk analysis, sensor systems and signal processing, artificial intelligence, modeling and simulation, and other mathematical, statistical or engineering methods as appropriate for each task.
3. Conduct sophisticated modeling and analysis, or develop new methods and models, applying principles and methods that include, but are not limited to: advanced statistics, including both Classical and Bayesian statistics, statistical process control, operations research, risk analysis, sensor systems and signal processing, artificial intelligence, modeling and simulation, and other mathematical, statistical or engineering methods as appropriate for each task.
4. Develop data identification and access plans that include the types and availability of data necessary to complete the specified analytic task and related evaluation…
