Determination of monitoring requirements
Based on the risk category of your study and the resulting risk assessment for the participating patients, we determine for you how the monitoring for your study should be designed.
Composition of study protocol sections
The study protocol describes how the monitoring for your study is to be organised and carried out. We will help you formulate this section.
Development of the monitoring plan
We develop a risk-based monitoring plan for your study.
Creating and maintaining the Trial Master File (TMF)
We create a Trial Master File (TMF) for you in your capacity as sponsor according to the applicable guidelines and complete it during the study so that you receive complete documentation at the end of the study.
Planning, conduct and documentation of monitoring visits
We carry out all types of monitoring visits (including initiation and close-out visits) and document them in monitoring reports. We can also train your staff in data documentation, safety reporting and query management.