This content was originally posted on Applied Clinical Trials on March 18, 2019
One of the most significant positive changes we have seen recently is the endorsement of ICH E6 (R2) which insists that Sponsors and CROs adopt a risk-based approach to study execution.
When the journey started it was all about monitoring. It was about addressing the inefficiencies, rationalizing resources to reduce costs and tackle potential quality issues that could put the clinical trial at risk. “Focus on what really matters” was born, Risk-Based Monitoring was alive.
We’re delighted to announce that registration for CluePoints’ US Risk-Based Quality Management Roadshow is now open. Taking place in January 2019, these roadshows will provide you the opportunity to network with Industry Subject-Matter Experts and learn more about RBx: A complete risk-based approach to clinical trials.
Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)?
Register to participate in the CluePoints Data Quality Challenge to find out first-hand how the ICH E6(R2) has given the industry, not only the a chance to become much more resource efficient while increasing data quality, but to realise huge cost avoidance benefits too.
Are you struggling with how to assess the true value of improving data quality and integrity through Risk-Based Monitoring (RBM)?
Now is your chance to find out first-hand how ICH E6 R2 has given the industry, not only the chance to become much more resource efficient while increasing data quality, but to realise huge cost avoidance benefits too.
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.…
