The targeted use of a literature search in the context of scientific studies offers an efficient way of accessing a comprehensive and differentiated database. Even before the start of the study, a thorough literature search helps to evaluate the relevant key points of the study design and create a sound basis for decision-making.

Depending on the product and the planned approval strategy, the scope of own clinical studies can be reduced by demonstrating the efficacy of an active substance or a form of therapy by referring to existing data from the scientific literature.

Already during the preparation of the clinical trial, we work with you to develop risk management plans (RMPs) in accordance with the provisions of the German Medicinal Products Act (AMG). The RMPs define the key aspects of the safety profile and the most important measures to avoid known risks. We draw up detailed RMPs with extensive information, documentation and training material, which also serves as the basis for subsequent pharmacovigilance measures during the course of the study.

We handle the pharmacovigilance notifications to the competent authorities: For medicinal products that are still in the study phase, we evaluate and develop the safety profile and prepare the regular reports for the authorities as part of DSURs (Development Safety Update Reports) in accordance with the ICH guideline.

Following approval, we monitor the safety and risk-benefit profile of medicinal products and report adverse effects and new findings from observational studies as part of PSURs (Periodic Safety Update Reports).

Depending on the risk profile, the safety of use of medical devices is monitored as strictly as for medicinal products. The vigilance systems prescribed in the MDR (MDR Art. 87 – 92) compile all relevant information, including from complaint processing, user reports and market surveillance. They define rules and specifications for evaluation and reporting to the competent authorities.

We establish carefully documented, MDR-compliant vigilance systems with clearly defined specifications for possible adverse events. It goes without saying that we also take care of timely regulatory reporting in accordance with national, European and international requirements.