Mentioned in 4 AI use cases across 1 industries
AI watches many places where safety issues might appear after a drug is sold and flags possible cases for the safety team to review.
AI helps check whether drug safety cases are complete and consistent, keeps a record of why decisions were made, and prepares reports in the right format for different regulators.
A setup workflow decides how a company will send safety data to EudraVigilance and gathers the technical details needed to activate that connection.
Use AI tools to check whether outside patient data is good enough and similar enough to fairly compare against a new drug study.
Certara worked with Brazil’s regulator so drug companies can send newer eCTD 4.0 application packages through GlobalSubmit instead of older, more manual methods.
FDA used the safety-review workflow to decide whether Entresto's pediatric warning label needed changes, and the reviewed data did not show a new problem.