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.
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.…
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.
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.