ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?
Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.
Why Centralized Monitoring and RBQM are Here to Stay
How it has taken a global pandemic to reinforce the intrinsic benefits.
How ICH E6 (R2) Offers Wins with Risk-Based Study Execution
Roundtable gathers industry experts to discuss the guidance update’s early implementation and the shift toward risk-based study execution approaches.
How ICH E6 (R2) Provides a Win/Win/Win through Risk-Based Study Execution
The industry-wide shift towards RBx is not only reducing risk, but improving oversight and boosting proactive, predictive decision making, writes Cluepoints' CCO, Patrick Hughes.
How Small and Medium-Sized Businesses Can Capitalize on New ICH E6 Regulations
Small and medium-sized businesses are seeking clarification on how the new ICH E6 guidelines will impact their business.
ICH E6 R2 Roundtable Review
The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry, writes Patrick Hughes.
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