Sentinel System Task Order to address an Emerging Safety Need
This AI project is designed to solve the problem of efficiently validating emerging safety signals through chart review when traditional structured data is insufficient. It aims t…
FOIA REDACTION (FRED) TOOL
FRED is designed to support FOIA staff in redacting records more efficiently and consistently. FOIA redaction can be a time-consuming process and experience large back-logs of req…
AI for Regulatory Review (AIRR) Pilot
The AI-assisted regulatory review paradigm addresses the inefficiency and administrative burden of manually searching through vast amounts of disconnected sponsor-submitted and FD…
AI-assisted Platform for Clinical Pharmacology Review
The AI solution addresses inefficiency in the clinical pharmacology review process by reducing time reviewers spend on routine tasks, allowing them to focus their expertise on com…
AI for Bioanalytical Study Risk Assessment and Inspection Readiness
Challenges in assessing large amounts of analytical/bioanalytical study information for risk assessment and inspection preparation in a short period of time
AI for Clinical Study Risk Assessment and Inspection Preparation
Challenges in assessing large amounts of clinical study information for risk assessment and inspection planning in a short period of time
AI for Assessing Bioanalytical Study Conduct Alignment with Guidance and Method SOPs
Cross-comparing large amounts of bioanalytical data (reports, validation, tabulated data) with the M10 guidance and aligned method Standard Operating Procedures (SOPs) to identify…
Renamed: Document Room Submission AI-Assisted Categorization Previously: Document Room Submission Auto-categorization
Current document room submission categorization process is very manual and costly, impacting end-to-end regulatory review acceleration by creating bottlenecks, increasing processi…
Renamed: AI-Assisted Drug Review Letter Drafting Previously: Drug Review Letter Generation using GenAI
This approach to AI-assisted document drafting provides faster implementation with minimal technical requirements, future-proofs document generation capabilities, reduces ongoing…