Archives: January 2018

CASE STUDY: ENSURING REGULATORY COMPLIANCE | ICH E6 (R2) Addendum | Optimizing Quality Risk Management

INDUSTRY CHALLENGE AND OPPORTUNITY: The recently revised ICH E6 (R2) Addendum provides both a challenge and opportunity for GCP organizations to modernize their QRM approaches.  By building quality in – starting with critical data & processes during  protocol development, using centralized and study risk-based monitoring, strengthening risk mitigation – organizations...

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Why do Clinical Studies Fail to Complete?

According to ClinicalTrials.gov, 3% (n=361) of all Phase 3 studies started from 2013 through 2017 terminated early. While that appears to be a relatively low rate, each of these instances represents millions to tens of millions of dollars in expenditure. Low Enrollment Highlighting the challenges with feasibility, incorporating Quality by...

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