Speaker: Sue Fitzpatrick , Jane Tucker , Ashok K. Ghone
Aggressive financial targets and reduced R&D budget are building tremendous pressures on life science companies to develop new drugs, therapies more quickly and cost effective manner. This further translates into planning, conducting, managing and monitoring of clinical trials efficiently to obtain desired quality of study data within planned timeline and budget that is more appropriate for regulatory submission. As the complexity of clinical trials has increased significantly in the last few years, it is becoming more challenging for drug development companies to manage the cost of clinical development. The clinical monitoring cost accounts for one third of the total clinical trial management budget. However, traditional ways of conducting frequent monitoring visits for example every 4‐6 weeks to investigational sites, and 100% source data verification, do not necessarily guarantee higher data quality, better patient safety, or identify the critical issues early on. Therefore, it is imperative to look into alternative and smarter ways to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner. Of the innovative monitoring approaches available, centralized monitoring appears to be the most suitable approach to enhance data quality and ensure patient safety in a cost effective manner. The FDA guidance document specifically encourages use of centralized monitoring techniques for certain monitoring activities, in place of, or to complement, traditional monitoring practices. Considering the need of centralized monitoring for efficient clinical trial management, MakroCare has organized this webinar in two parts to provide more insights on the process and implementation of centralized monitoring.
Centralized Monitoring: Understanding Concept & Process
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