Personalizing the Power of Statistical Analysis and Data Visualization
King of Prussia, PA – June 26, 2020: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software for clinical trials, today announced the launch of its new business intelligence platform, BEYOND. Designed to encompass more than just early risk detection, this extended visualization solution takes CluePoints beyond the interrogation of data and allows Sponsor and CRO users to explore areas of interest in one integrated business intelligence system. The powerful analytics tool allows users to confidently certify the quality and integrity of data whilst ensuring patient safety and regulatory compliance. Learn how the BEYOND business intelligence platform can help you reach your clinical trial goals here.
Francois Torche, Co-Founder & Chief Executive Officer of CluePoints comments, “We are very excited to launch our novel clinical trials business intelligence platform as an extension of our ongoing commitment to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management. It is a key milestone in our strategy to become a knowledge company and we would like to thank those sponsors who have collaborated to bring this vision to life.”
As the industry realizes the benefits of Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM), users are looking for ways to extend the way they drill-down into risks and focus on what matters most within their studies. The comprehensive nature of the analytics offered within this novel business intelligence platform gives all users the data exploration tools and personalized visualizations they need to test hypotheses and drive critical thinking. Within one unique platform, risk signals can be identified, and an embedded Issues and Actions Management system ensures that all evidence is fully documented and accessible. This guarantees full compliance with ICH E6 (R2) and other global regulatory requirements throughout the lifecycle of the clinical trial.
Clinical trials business intelligence
Francois continued, “BEYOND facilitates a deeper understanding of what is happening within a clinical trial. Study teams can focus on a specific area of the clinical trial, such as the Safety Profile and the status of Adverse and Serious Adverse Events for example, as well as take a wider focus on clinical data by plotting vitals and lab results, and exploring connected data. They can track enrolment and screen failures, and even look at operational data, such as missed assessments or query turnaround.
“With BEYOND, no data quality stone is left unturned. It offers a view of the data from every angle, at every step of the trial, uncovering insights, highlighting potential problems, and enabling corrective action.”
As pioneers in the field of RBM, CluePoints are poised to respond to industry demand, ensuring sponsors, CROs and Clinical Technology Partners benefit from constant innovation and transparency.
This all-encompassing platform offers an exclusive combination of both supervised and unsupervised data surveillance techniques that enables users to test what they think they know, as well as what they could not possibly know or suspect. The ability to select or create the appropriate visualization to explore that data in its most powerful format offers actionable insights across safety, clinical, enrolment and operational aspects – BEYOND presents data in the way the team want to see it, from every angle and in whatever visual format they need. Combining business intelligence, analytics and reporting in one platform enables greater knowledge sharing for data-driven success.
The benefits of BEYOND include:
- the ability to better understand what is happening within clinical trials – BEYOND features data summarization and aggregation capabilities that have been designed to effectively communicate the desired insights and to support critical thinking
- the ability to explore and focus on those data points that carry the highest risk and that matter the most to study teams – BEYOND is anything but static. It provides a highly dynamic view of the available data and provides results that can be easily shared with the whole team
BEYOND allows study teams to:
- explore risk emergence in the underlying data
- use dashboards to open up new insights
- use dashboard to identify new risks or operational problems
- change, create and edit dashboards to suit the desired data view
- track the items that matter most with multiple dashboard date widgets
- use widgets to combine data from different domains
- compute data or results even when they are not natively present in the source data
For further information on CluePoints’ solutions, please visit www.cluepoints.com
Notes to editors:
What is risk-based monitoring?
Risk-based monitoring (RBM) is the process of identifying, assessing, monitoring, and mitigating the risks that could affect the quality or safety of a clinical trial. The proactive approach allows the study team to move away from 100% source data verification (SDV) – a time- and resource consuming approach that provides far from perfect results – and instead focus resources on high-value tasks.
First written into US and European guidelines back in 2013, RBM received further validation with the publication of the ICH E6 (R2) in 2016.
Many pharmaceutical companies, sponsors, and CROs now follow the TransCelerate RBM methodology. It is a robust risk identification process that allows trial designers to evaluate study risks, and organize them into the following categories:
- Safety study phase
- Subject population
- Data collection/ CRF source
- End points
- Organizational experience
- Investigational product/ study medication
- IP logistics / supply chain
- Operational complexity
What is centralized statistical monitoring?
Centralized statistical monitoring (CSM) is can be described as a data quality insurance policy. It provides a way to identify and respond to less obvious risks, or those that may not have been identified through risk assessment processes.
Data surveillance, through a central statistical assessment of data quality, can flagging anomalies that warrant further investigation.
It works on the assumption that data should be comparable and statistically consistent across centers, other than random fluctuations and natural variations. Unsupervised CSM performs as many statistical tests on trial data as possible to detect inconsistencies that may point to potential problems, without placing additional burden on study teams.
It can spot atypical patterns that represent potential intentional or non-intentional misconduct, such as fraud, sloppiness, training needs, or malfunctioning or mis-calibrated study equipment.
What is risk-based quality management?
Risk-based quality management (RBQM) brings all of these elements together and applies them to the entirety of a clinical trial.
It uses technology, real-time information, and analytics to monitor risk, giving sponsors the ability to identify and correct issues as and when they arise. This enables sponsors and CROs to take corrective action before problems have a chance to impact on the integrity of a clinical trial.
Its fundamental goal is to improve the operational success rate of clinical research through higher quality data, shorter timelines, and greater operational efficiency.
RBQM boosts both participant safety and the likelihood of trial success. As such, it has been backed by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Committee on Harmonization (ICH).
By helping researchers to identify and focus on data that really matter, tech-led RBQM solutions provide the ultimate safety net, both from a patient safety and ultimate success perspective.
The ICH E6 (R2) guideline set out what a gold standard RBQM would cover:
- Critical process and data identification
- Risk identification
- Risk evaluation
- Risk control
- Risk communication
- Risk review
- Risk reporting
Beyond use cases
BEYOND is a powerful clinical trials business intelligence platform which can support study success and RBQM by generating invaluable, actionable insights. Possible use case examples include:
Delivering safety insights: Teams can take a top-down approach to understanding safety data. They can, for example, examine the distribution of adverse events across countries/regions and sites. BEYOND’s interactive dashboards allow Sponsors and CROs to elect a specific data point and country or region, then compare results across sites.
Delivering clinical insights: BEYOND provides direct access clinical and medical data, which can be combined into dashboards and visualizations. By arranging numeric data, such as blood pressure, into scatter plots, teams can conventionally spot outliers, and quickly take action when necessary.
Delivering enrolment insights: BEYOND allows teams to focus on enrolment rates and screening failures. They can, for example, combine these two metrics into a single visualising to track how their progress over time. BEYOND also provides access to data from all source systems, including IRT and EDC, allowing study leaders to compare predicted and actual enrolment rates and screening failure figures.
Delivering operational insights: BEYOND also supports operational data analytics. It can, for instance, create visualisations of missed assessment rates by country and by site. Teams can combine all operational metrics into operational dashboards for the trial as a whole, or themed and focused to support specific roles, such as data managers or CRAs.
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Our products utilize comprehensive statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation you now have everything you need to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.
More than 2,500 organizations use CluePoints platforms to de-risk their clinical trials and give them the best chance of study success.
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Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749