Development phase

Your partner for clinical trials

As the sponsor of clinical trials you are responsible for the recording and processing of any adverse drug reactions that occur in the course of a trial. Particularly where multicentric trials are concerned, this presents you with a considerable challenge.

Filing of SUSARs and writing of annual reports

We support you in ADR management – both prior to marketing authorisation and in clinical trials involving authorised medicinal products. Working together with the investigators we record all serious adverse events and – if necessary – unblind the clinical trial.

Management of SUSARs and periodic reporting

On your behalf, we report SUSARs to the Ethics Committees, the supervisory authorities and the investigators involved. All reported reactions flow into the annual reports which we prepare on your behalf and send to the responsible bodies.

Reliable follow-up measures

We concern ourselves on your behalf with cases which occurred during exposure to a medicinal product during pregnancy. Furthermore, we reconcile the number of ADR cases from clinical trials with your pharmacovigilance database.