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Envisioning the site of the future

The drug development world has been notoriously slow to adopt change, but industry leaders and visionaries expect the clinical research enterprise to change dramatically.

Preparing for the ICH E6 Revisions

In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.

Also in this issue:

• Shift focus to rheumatoid arthritis subjects
• Resolving the conflict between feasibility and relevance
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline