Monthly Archives: November 2016

Nov 2016

RBM: innovation or just common sense?

By | 2016-11-24T10:01:15+00:00 November 24, 2016|Blog|0 Comments

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. [...]

Nov 2016

ICH Finalized GCP Addendum E6 Revision 2

By | 2016-11-18T16:59:14+00:00 November 18, 2016|News|0 Comments

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 [...]

Nov 2016

WHO Guideline on Good Data and Record Management Practices is Final

By | 2016-11-16T18:35:27+00:00 November 9, 2016|News|0 Comments

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 [...]

Nov 2016

The Emergence of a “Risk Monitor”: Preparing for the future.

By | 2016-11-16T18:35:28+00:00 November 9, 2016|Blog|1 Comment

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 [...]

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