What does the system do?

The Study Quality Assessment Application objectively assesses risks of the study protocol and study setup at predefined time points, before and after protocol approval. The assessments are based on the completion of a comprehensive questionnaire which covers essential risk categories such as Study Design, Medication, Outsourcing etc.

The Trial Site Assessment Application enables broad-based automated screening for risks at the trial sites. This is achieved by using a set of industry-tested Key Risk Indicators which detect risks at all stages of the trial including: Over/Under-Enrollment, abnormal Adverse Event Reporting, Monitoring Issues, etc. The assessment results provide an excellent basis for steering Risk Based Monitoring activities.

The Risk Mitigation Tool automatically generates mitigation tasks for each identified risk and thus enables risks to be analyzed, tracked and controlled. This easy-to-handle intuitive tool is a key element in the creation and maintenance of risk management plans for carrying out risk-based monitoring.

How to load data into the system?

Clinerion offers a set of standardized Data Integration Adaptors that are available to collect and deliver data to the QRM System. These adaptors provide data integration from leading clinical trial management systems (CTMS), electronic data capture (EDC) systems and safety systems.