Case management

Systematic case management

Benefit from our know-how in pharmacovigilance. Our experienced staff will provide you with customised support or take over the entire case management process on your behalf. From the creation and assessment to the database entry and reporting of ADR cases – also electronically, of course.

Your ADR cases in safe hands

You forward your ADR reports to us. Their source – doctor, patient, literature, clinical trial, field staff – is of no consequence. Our drug safety specialists input all the data in your pharmacovigilance database. On request, we provide you with a completely validated and e-reporting-compatible database.

Complete quality control

When conducting quality assurance of the data entered, our case managers strive for complete control. We process the medical evaluation of adverse drug reaction reports and assess the effects on the risk-benefit profile of your medicinal product. We complement incomplete case data by means of pre-defined follow-up processes.

Monitoring adverse drug reactions

If necessary, we report ADR cases on your behalf to authorities within or outside Europe. To this end, we also employ E2B standard electronic case reporting.