Safety Office

Creation and review of security-relevant documents
We support you in the creation and review of all important security documents in order to meet the highest quality and compliance standards:

• Safety sections in trial protocols
• Patient information and informed consent (PISIC)
• SAE forms (Serious Adverse Events)
• Safety Agreements

We take over the complete management of adverse events during your trial:

• Triage - prioritization and classification of cases for rapid action
• Medical assessment - assessment of severity, causality and impact on patient safety
• Data entry - Accurate and efficient recording of safety-related data
• Narrative writing - creating clear, detailed case reports on adverse events and patient outcomes
• Query management - processing and clarification of all safety-related queries

We prepare and submit expedited safety reports (e.g. SUSARs) in a compliant and timely manner - including the management of queries to avoid delays.

Our team prepares well-founded Annual Safety Reports (ASR) and Development Safety Update Reports (DSUR) - precise, complete and compliant with regulations.

We take care of the timely and correct transmission of safety-relevant data to EudraVigilance, the European system for reporting adverse drug reactions.