Quality Management System frameworks have existed across different industries, from aviation to car manufacturing, for years. But it’s actually only the past decade or so that they have been introduced in clinical trials to improve trial speed, efficacy and quality.
QMS in clinical trials often begins with the simple things – for example compiling best practices together into unified documents system. It is sufficient to improve staff confidence (people know what to do and how). If you add regular managerial meeting and review, accountability and continued improvement than your QMS will expand.
During this training you will learn the basics about QMS and QMS in clinical trials: definitions, structure and benefits. There will be also examples presented of the gaps in QMS and their consequences.
The training is dedicated to less experienced staff from the investigational sites, CROs, pharma or biotech companies or vendors who support clinical trials conduct. Everyone is part of QMS, if such is developed.
