Risk-based and Remote Monitoring

With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar will focus on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics will include remote and centralized monitoring and their role in the risk-based approach.