Dismantling Data Silos to Improve Study Startup and Mitigate Risk
May 22, 2018 - Toronto ON CAXtalks
fbonilla@xtalks.com
Phone:416.977.6555
In this webinar, featured speakers will explore: *How automated workflows encourage upfront planning and downstream improvements in the eTMF *Why an upfront emphasis on quality in study startup is essential, including what factors to consider in order to mitigate risk (e.g., Which countries will be used? Which sites/investigators will be used? Which artifacts need to be identified and structured? etc.) *How the International Conference on Harmonization ICH-GCP E6(R2) guideline defines Quality Management and builds on the foundation of regulatory documents released by the EMA and FDA *Why breaking down organizational silos is critical to reducing quality issues *Why management direction is critical in efforts to jump-start overall performance optimization