Process – Risk – Management
The success of any clinical trial is defined in the planning phase. The clinical trial is a complex process, which incorporates a number of internal (e.g. safety, protocol compliance, financial) and external (e.g. political, cultural) risks. Each risk has its own importance for a company and therefore must be analyzed locally in the context where a clinical trial takes place.
The Risk Defense Strategy, which Cyntegrity creates for its customers, can be compared to a house around the primary research outcome:
In order to de-risk a protocol of a trial Cyntegrity offers the following services:
Before clinical trial:
- Risk analysis of the clinical Protocol (evaluation how risky the protocol is)
- Definition of “Design space”
- Finding the suitable Key Risk Indicators (KRIs)
- Elaboration of Risk Defense Strategy
- Writing of Monitoring plan and Risk-based Monitoring (RBM) plan
During clinical trial:
- Automatic monitoring of such risks as:
- protocol violation,
- protocol amendment,
- technical defects of EDC Software,
- fraud,
- misconduct of devices,
- wrong calibration,
- poor patient recruiting
- Adjustment of the risks’ weights
- Configuration and development of the new KRIs
After Clinical Trial:
- Risk Management Study Report
- Retrospective analysis of a clinical trial
- Summing up the “Lessons learned” from the risk management
Interested in learning more about Cyntegrity and our services?