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.

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.