One of the major changes in the ICH regulations in recent years (ICH E6 R2) has been the requirement for clinical trial teams to implement a more robust risk management process before starting clinical trial activities. From a practical standpoint, this goes back to the protocol and involves identifying and managing those processes/ data critical to patient safety and data integrity.
Management of risk during clinical trials is critical not just from a regulatory perspective but it makes business sense. Failure to identify, manage and mitigate risks in a trial can be costly in terms of time lost fixing problems, reputation not to mention the impact to patients currently on the clinical trial or those waiting for life saving treatment. Our services around Risk Assessment and Management cover activities such as:
- Development of processes for risk identification, mitigation and management;
- Presentation of risk through dashboards/ heat maps;
- Facilitation of risk management discussions and mitigation activities.