Data Extraction from IND Safety Reports using OCR/AI Technologies
Description
Manual extraction of data from IND safety reports is labor-intensive and time-consuming for regulatory staff.
Detailed example
Using ThinkTrends, a COTS tool, extracted data is converted into E2B(R2) format for automatic ingestion into FAERS LSMV
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Expedited processing of Investigational New Drug (IND) Safety Reports received by the Agency, enabling more rapid regulatory action in response to reported adverse events and better protection of clinical trial participants.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
MedWatch 3500 forms and intake system processing logic