Adverse event reporting and pharmacovigilance

Step-by-Step Breakdown

Detailed explanation of each automated stage in the workflow.

1. 1

   Trigger

   Receive adverse event report

   System detects incoming adverse event report from various sources including patient portals, healthcare providers, or clinical trial platforms. Initial data validation and standardization occurs.

   Oracle ClinicalMedidata Rave
2. 2

   Action

   Extract and standardize data

   AI system extracts relevant medical information, patient demographics, and drug details using NLP. Data is mapped to MedDRA coding standards for regulatory compliance.

   SAS Clinical TrialsIQVIA CORE
3. 3

   Decision

   Assess severity and causality

   Algorithm evaluates the adverse event severity, determines causality relationship to study drug, and classifies urgency level. Routes serious adverse events for expedited processing.

   SAS Clinical TrialsSpotfire Analytics
4. 4

   Action

   Perform safety signal detection

   Statistical analysis compares event against historical safety database to identify potential new safety signals. Machine learning models flag unusual patterns or emerging risks.

   Spotfire AnalyticsIQVIA CORE
5. 5

   Action

   Generate regulatory reports

   System automatically creates required regulatory submissions including CIOMS forms, periodic safety reports, and expedited reports. Documents are formatted per regional requirements.

   Veeva VaultOracle Clinical
6. 6

   Action

   Submit to regulatory authorities

   Automated submission of safety reports to FDA, EMA, and other global regulatory bodies within required timelines. Confirmation receipts are tracked and stored.

   Veeva VaultIQVIA CORE
7. 7

   Output

   Update safety database records

   All processed adverse event data, analysis results, and regulatory submissions are permanently stored in the pharmacovigilance database. Audit trails and compliance documentation are maintained.

   Veeva VaultOracle Clinical

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