The article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting. [...]
The ICH GCP Addendum E6 R(2) is final now! Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted [...]
The WHO guideline on Good Data and Record Management practices is now final, below you find the link. Particularly interesting is that this guideline talks about quality risk management: Quality risk management and sound scientific principles. Robust decision making requires appropriate quality and risk management [...]
Pharmaceutical companies and contract research organizations (CROs) are increasingly trying to leverage technology to optimize risk-based monitoring. While technology is a critical component, roles also need to be looked at again. Recently we interviewed Dr. Nimita Limaye, an expert in risk-based monitoring, about the future [...]
