Safety Data Management

The capture and analysis of safety data is critical in Clinical safety and post-marketing safety. Our internal healthcare professionals (pharmacists and physicians) complete all case processing and quality review activities with particular attention to timelines and submission requirements for local regulatory authorities.

We can deal with all translations to/from local languages as part of the case management process.

We provide end-to-end case processing of all kind of adverse events and special situations.

Coding in the Medical Dictionary for Regulatory Affairs (MedDRA) is mandatory in most regions worldwide, and we provide a complete up to date MedDRA coding service for the processing of all case reports.

Our team of experts has extensive experience in providing safety data Management specializing in ICSR processing and analyzing safety data including case intake, data entry, coding, medical review, follow up, quality control, and reconciliation.

We can follow up different timelines for reconciliation activities to work with global headquarters of Pharmacovigilance Team.

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