ICH E6 R2 – The Clinical R&D Industry’s Response

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For decades now the complexity, cost, and duration of clinical development have been steadily increasing while profit margins for the industry have been dwindling. This crisis persists and is compounded by inefficient traditional methods of managing clinical trial quality. The ICH Good Clinical Practice Guidance Integrated Addendum (ICH E6 R2) provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland.

New Webinar Announced: Risk-Based Monitoring for All

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JOIN US FOR OUR UPCOMING WEBINAR:

RISK-BASED MONITORING FOR ALL

How the ICH E6 (R2) has given clinical development organizations the perfect opportunity to improve and lower costs through adoption of RBM and Centralized Monitoring

Tuesday, March 6, 2018, at 10 AM EST/3 PM GMT/ 4 PM CET

For this webinar, CluePoints’ Chief Operations Officer, Steve Young, is teaming up with Jason W.

CluePoints Responds to Sponsor and CRO Demand with Two New Appointments

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5 December 2017

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced two new strategic appointments to strengthen its business development team. Nick Borders and Rob Estrella join the CluePoints US team to support its impressive global business growth, allowing the company to increase its expanding client base across North America.…

Beyond Risk-Based Monitoring: How Intelligent Analytics are Being Used to Drive Value and Support ICH Compliance

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The complexity and size of clinical trials has increased dramatically – in parallel with growing costs and mounting regulatory pressures. The introduction of the finalized International Council for Harmonization’s (ICH) addendum to the ICH E6 Guideline for Good Clinical Practice (ICH E6 R2) earlier this year means that organizations across the industry are currently reviewing the update to understand its implications, including assessing the need for revised strategies and operating models.

The Bigger Picture of ICH E6 R2: Looking Beyond Compliance

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Journal for Clinical Studies

Steve Young, Chief Operations Officer, CluePoints

The introduction of ICH E6 (R2) this past year has rendered the implementation of risk-based monitoring principles a matter of GCP compliance.  While clinical research organizations across the industry are now finally compelled to study the new guidance in order to roll out a compliant RBM strategy, many are still not recognizing the incredible opportunity presented by this paradigm shift. 

CluePoints Builds on Late Phase work in Japan and Launches Risk-Based Monitoring Roadshow in Tokyo

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Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase work in Japan by entering into two new partnerships with global top 20 pharmaceutical companies. The collaborations mark the latest success for CluePoints in the region, with its centralized statistical monitoring (CSM) platform having already been used by the Nagoya University School of Medicine for an eight-year Phase III Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT).

ICH E6 R2: Talking Big Pharma’s Response To The Addendum

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This article was originally produced for Clinical Informatics News

The introduction and implementation of ICH E6 R2 has raised many questions surrounding operational risk-based approaches to clinical trial oversight. With the industry now in the process of getting to grips with more modernized practices for study conduct mandated by the guidance, this article addresses how sponsors are working to understand and interpret the obligations, as well as overcome the resulting challenges.