New Setting - Old Principles at ACDM 2017
ACDM 2017 - Conference Review
The ACDM Annual Conference 2017 was hosted in Brussels in a move away from the usual UK base, resulting in a truly European audience. The Chair of the ACDM welcomed us all and reminded us that throughout this transition period of new technologies and regulations to stay true to the QPR principles - Quality, Protection and Responsibility.
The two key note speakers brought a diversity of approaches to the meeting, from the impending implementation of regulations set out in ICH E6 (R2) in June 2017 and the move to Risk Based Monitoring (RBM) to the challenges faced by Médecins Sans Frontières (MSF) when delivering emergency aid in exceptionally difficult circumstances.
Aspects of e-data were central throughout the presentations, including it's role and contribution in the setting and monitoring of Tolerance limits, the quality measures required for Clinical Trials based on statistical and medical knowledge. The effect of eSource on EDC and the electronic Trial Master File (eTMF), centralised monitoring, monitoring strategies and Risk Indicators were key focal points for discussion together with how to address data security in a cloud based environment and best practices for implementing such applications.
While the traditional role of data management is essential in ensuring the integrity of the data, a central statistical review should analyse site characteristics and performance metrics. The integration of these skills and the evolving role of a 'Clinical Data Scientist' (as it was referred to by one speaker), is at the heart of central reviews and analytical tools was evident from the presentations. With June 2017 just around the corner, it is re-assuring to know that Phastar's approach to quality definitions, it's systems, processes and initiatives puts us in a very good position going forward, and in particular the QPR principles.