ICH E6(R2) has ushered in an era of risk-based quality management (RBQM). Yet, many sponsors struggle with the aspect of RBQM that drives the most value - Central Monitoring. Pharma Initiatives has developed a practical guide for successful Central Monitoring based on its experience working with dozens of sponsors. In this one-hour webinar, Pharma Initiatives will share its Central Monitoring best practices, whether you control all the study execution or you outsource to CROs. Time will be reserved for questions and answers at the end of the presentation. Please join us.
Gary Tyson is an expert on clinical operations with over 30 years of experience consulting to both biopharma and CROs. Gary has been actively involved in setting industry best practices for ICH E6(R2) and has worked with many sponsors and CROs to help successfully implement those best practices. Gary founded Pharma Initiatives on the premise that "People Support What They Create." Gary and staff at Pharma Initiatives view their role as partner, driver and supporter of major operational change but always with the client owning and leading the change initiatives. Only in that way does change become successfully embedded.
Cody Vientos has successfully implemented ICH E6(R2) at a range of mid-sized sponsors and CROs. Cody is an expert at helping his clients determine how to apply best practices to their unique circumstances, ensuring that new practices are both defined and rolled out. Cody is committed to Pharma Initiatives approach that “People Support What They Create” and always serves as a partner, driver and supporter of major operational change but always with the client owning and leading the change initiatives.