Considerations in RBM Implementation

In this 5th Edition of Applied Clinical Trials' eBook on Risk-Based Monitoring in Clinical Trials, articles cover the advances that have been made in RBM since guidances' released in 2013. How is pharma implementing RBM - is it more remote, centralized or a combination? Read the article by Dr. Ashok Ghone, Vice-President, Global Services at MakroCare:Considerations in RBM Implementation

CER : new MEDDEV 2.7.1 REV 4: Why is This More Complex Now

In July’2016, the EU has published Rev.4 of MEDDE V2.7.1 on clinical Evaluation for medica l devices.The new guidance document describes the requirement in a more detailed

Central Monitor: A Key Driver of Centralized Monitoring, published in Applied Clinical Trials

Centralized monitoring offers many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of various eClinical technologies, analytical and visualization tools.

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