King of Prussia, PA, 10 September 2019– FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research. Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk.
This is the question on everyone’s mind and one that we’ve addressed many times with Sponsors & CROs.
Strategic collaboration leverages CluePoints’ Central Statistical Monitoring (CSM) technology to enhance data quality and reduce operational costs
Wayne, PA, June 18, 2019– Parexel, a leading provider of Clinical, Consulting and Commercial solutions to accelerate the development of innovative new therapies to improve the world’s health, today announced its strategic collaboration with CluePoints, an industry-leading provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, to enhance overall data quality oversight and ensure regulatory compliance within clinical trials.…
Wayne, PA – April 09, 2019: CluePoints, a leading provider of Risk-Based Study Execution(RBx) and Data Quality Oversight solutions for clinical trials, has announced a progressive outlook of continued and significant global growth and continued investment in people and technology throughout North America, Europe and Asia Pacific.
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.
