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.
Literature surveillance services
Our Vigilit® system is a quality-assured environment that accomplishes all the functions related to your legal obligations for literature surveillance. After setting up searches in consultation with you, we continuously monitor the safety literature for your product, process detected case reports in a CIOMS I or E2B-compatible format, and push them through to you. Other safety-relevant literature can also be provided or feed into our continuous monitoring services.