Patient safety is at the core of every healthcare innovation. Our pharmacovigilance (PV) services are designed to help clients meet global safety regulations while maintaining efficiency and data quality. We support both clinical trial safety (pre-marketing) and post-marketing surveillance.

Functional Capabilities:

ICSR (Individual Case Safety Report) Processing

Case intake from multiple sources: clinical trials, spontaneous, literature, EHRs, regulatory databases

Triaging, duplicate checks, MedDRA coding, narrative writing, causality & seriousness assessment

Medical review and quality control

Submission of E2B-compliant XML files via safety gateways (FDA EVWeb, EudraVigilance, MHRA)

Aggregate Reporting Services

Development of DSURs, PBRERs/PSURs, RMPs, ACOs, and addendum reports

Compilation, data integration, and literature support

Medical writing and safety analysis based on global PV guidelines (ICH E2E, GVP Modules)

Signal Detection and Risk Management

Quantitative signal detection via disproportionality methods (PRR, EBGM, IC values)

Qualitative signal evaluation and validation

Risk minimization strategy development and implementation support

Creation of RMPs aligned with EU/US regulatory expectations

Safety Database Management

Setup, configuration, and administration of PV systems: Oracle Argus, ARISg, Veeva Vault Safety, PVWorks

Compliance validation, upgrade management, and migration support

Report scheduling, auto-narratives, and CIOMS form generation