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.
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.
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.…
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.
January 31, 2018
Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has been honoured in this year’s Biotechnology Awards with the CluePoints® solution being named the “Best Risk-Based Monitoring Solution”.
22 January 2018
Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has launched the “CluePoints RBM and ICH E6 (R2) Starter Pack” to help small and medium-sized enterprises (SMEs) achieve regulatory compliance through a “risk-based” approach.
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.…
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).
We’re delighted to announce that we’ll be at Partnerships in Clinical Trials next month! You can find us at booth 120, where we’ll be showcasing our innovative Risk-Based Monitoring solution that employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data.…
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.