Draft coded case narratives and causality flags from intake, so safety teams meet regulatory submission deadlines without falling behind on volume.
Every adverse event case gets manually re-keyed and coded before it reaches the safety database, and that repetition eats into the days available before the regulatory submission clock runs out.
Case quality review before submission is a recurring bottleneck, and rising report volume keeps adding pressure to a fixed deadline.
MedDRA coding and preliminary causality flag from intake source documents
Review and code sign-off
An adverse-event case narrative was drafted with a preliminary causality flag of "possible," but the case-quality QA pass flagged an inconsistency between the coded MedDRA term and the source document's described symptom, ahead of the E2B submission deadline.
Try it — same review surface your operators use, with a representative decision. Nothing here is saved or sent anywhere.
Causality judgment, MedDRA coding accuracy, and the final case sign-off before submission stay with your pharmacovigilance team. The system only prepares the case for their review.
See this workflow against your own queue.
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