Confidence Beyond Compliance

ICSR Management
We offer the full range of case processing services from collection, database entry, coding and medical assessment to regulatory submission.  Our drug safety specialists will take over single aspects or the entire case processing service. We can operate with your own pharmacovigilance database, or provide you with a complete case processing solution that includes a validated, E2B-compatible database.

Ongoing monitoring and signal management

Our experienced experts can take over continuous monitoring of the safety data associated with your product for safety signals. Upon detection, we will provide assistance with signal validation, prioritization and assessment, and work with you to define and implement corresponding actions.

Risk management
Our multidisciplinary team of experts is available to support you with the risk assessment for your product and the development and preparation of the Risk Management Plan. We can support you in developing and implementing of additional risk minimization measures and with measuring the effectiveness of such measures. With experts in Europe and the United States, we are able to provide comprehensive global assistance.

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