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.
Wayne, PA – October 02, 2018: CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has announced the appointment of two industry thought-leaders to its senior team, as it continues its impressive global growth throughout North America, Europe and Asia Pacific.
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.
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.
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.