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.