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Gemma Telfer

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.

CluePoints V1.12.0 is Live!

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Today, we’re excited to announce that we’ve added an abundance of new features to the CluePoints Central Monitoring platform. From out-of-the-box integration for data sources to more in-depth Patient Profiles reporting, our latest version is sure to delight. This new release demonstrates our ongoing commitment to continuously evolve our platform and add in features requested by our vast user base.

ICH E6 R2 Roundtable Review – What Does This Mean for the Industry?

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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. In response, and to better understand the perception of the new guidance by Pharmaceutical companies, Tufts, CluePoints and PWC organized a roundtable, which included senior executives from top tier pharmaceutical organizations that have responsibility for facilitating the changes required by the new guidance.

ICH E6 R2: Waiting and Watching no Longer an Option When it Comes to Risk-Based Monitoring

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As is typical of our industry, despite ringing endorsements of Risk-Based Monitoring (RBM) from both the FDA and EMA back in 2013, researchers have been conservative with respect to adopting this proven approach as standard within their clinical trials.

However, the introduction of ICH E6 R2 this year means that waiting and watching is no longer acceptable.…

CluePoints Opens U.S. Office

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2 May 2017

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, today announced that it will be expanding its operations in the U.S. with the opening of a new office in Wayne, PA.…