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ICH E6 R2 Breakdown by Section

This ICH GCP Guideline Integrated Addendum Breakdown provides a quick overview of the unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the…

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TRI Position Paper – Designing Risk Metrics 22Oct2013

1. Background Triumph Research Intelligence (TRI) was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. Over the past 12 months TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as…

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OPRA Slide Presentations

Why? If a company wants to take a risk-based approach to monitoring, it must be able to prove it has a quality risk management plan which it executed, measured, and adjusted over time. How? TRI developed a purpose built application based on industry guidance that identifies site quality risk and allows central management of monitoring and risk mitigation activities What? OPRA…

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