The CluePoints & HighPoint Solutions Risk-Based Monitoring Roadshow Recap

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The other week, CluePoints in conjunction with HighPoint Solutions delivered 3 European Roadshows in Basel, Copenhagen and Cambridge, focusing on practical, case-based methods for addressing the challenges of Risk-based Monitoring (RBM). As well as hearing from key opinion leaders in the industry, each event was an ideal forum for attendees to share thoughts and experiences.

Quanticate partners with CluePoints to offer Data Quality Oversight capabilities

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Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints to utilize their software to drive the statistical analysis to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service that enables centralized statistical monitoring, in response to the  amendments to the ICH Good Clinical Practice (GCP) E6(R2) guidelines.

The CluePoints & HighPoint Solutions RBM Roadshow is Coming to a City Near You!

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Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2) addendum, which came into effect in June 2017,  encourages sponsors to develop a prioritized, risk-based approach to monitoring. However, despite the guidance, some sponsors are still unclear on how to achieve the “gold standard” for monitoring, study execution and oversight.

CluePoints Awarded Most Reputable Clinical Trial Risk-Based Monitoring Software 2018

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It appears that 2018 is the year CluePoints really established itself as a leader in the industry! Having recently being honoured in the Biotechnology Awards for our Industry leading Risk-Based Monitoring Software, in the form of the CluePoints Central Monitoring Platform, we’ve just been informed that we’ve clinched the title of “Most Reputable Clinical Trial RBM Software Solution 2018” in CV Magazine’s Corporate Excellence Awards 2018.…

CluePoints Announces Four Year Partnership with ONO Pharmaceutical and Strengthens Risk-Based Monitoring Position in Japan

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July 9, 2018

Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has entered into a significant enterprise agreement with leading Japanese drug development organization, ONO Pharmaceutical Co., Ltd. The agreement sees ONO utilizing the CluePoints centralized statistical monitoring (CSM) platform to drive its RBM strategy over a four-year period and firmly strengthens CluePoints’ established presence in the Asia Pacific market.

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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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.