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Quality Risk Management for Drug Safety | Der Vortrag muss leider entfallen.

A quality risk radar for clinical development is a vital means to ensure that trial activities are speedy and safe. Such a system enables the early identification and proactive mitigation of risk on planned development activities. Early identification allows for the intervention in running processes so that one can mitigate risks and maintain process integrity and momentum.

In order for risk management operating models to be successful one requires data collection tools that either automatically extract data from available databases or with undemanding tools assist participants to submit data without significantly increasing their monitoring or compliance burden. These data are fed into simple and adaptive analytics systems to traverse the complexity of the reporting, compliance and quality assurance requirements of clinical development. By doing so they derive useful insight to support risk management of the clinical development process. To ensure that the findings are meaningful, baseline assessment and benchmarking of the data permits the creation of boundaries within which clinical development process performance and integrity can be objectively assessed.

This presentation shows the rationale for utilizing risk radar for the quality management of outsourced clinical trials and in so doing highlights how this facilitates better performance of prospective clinical trials.