Case study: Pharmacovigilance, clinical safety and regulatory

Organizations increasingly require auditable methods to check whether signals indicating adverse or toxicity related events appear in clinical records. If events do occur, companies need to be able to react fast to find out if they are caused by the drug, are side effects of the original disease or are the result of external factors.

Text mining can be used both to review clinical reports and also to understand potential mechanisms of action. In particular Linguamatics I2E has been used to highlight different adverse event profiles at different dosages. Researchers can also search medical records for particular adverse effects, and code the effects found. The linguistic capabilities of I2E are critical in providing a distinction between new effects, a history of an effect, the lack of an effect, or the lack of a history of an effect. 

Reviewing Medline reports to monitor potential adverse effects