Clinical Forum for Operational Excellence 2016

Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. Particularly 2016 will bring important changes in the European Regulatory framework once the ICH E6 Addendum kicks in. At that time ‘Quality’ is no longer the outcome of well-designed processes, but it should be an explicit and very well-considered strategy in the way we design our processes and studies. Risk-Based Monitoring will be codified in Good Clinical Practice, and many organizations will have to revisit their Standard Operations Procedures, processes and study-related documents. And obviously, this will have an impact on the roles of professionals working in clinical development.