CluePoints, the premier provider of Risk-Based Quality Management Solutions for clinical trials, has launched a new Post-COVID Trial Assurance Solution as part of its mission to build safer, more efficient trials for patients, sponsors and, CROs.
The pandemic has been the catalyst for many sponsors and CROs to reassess pre-existing monitoring protocols to ensure studies stay on track, particularly when on-site monitoring is not an option.
The new CluePoints Post-COVID Trial Assurance Solution offers study teams the opportunity to assess the quality of their data within a defined timeline and with limited resources. It goes beyond traditional key risk indicators to evaluate 100% of the clinical data to assess expected risks, while also identifying data anomalies that might indicate unexpected risks – surfacing issues which can be found rapidly by leveraging CluePoints’ Central Statistical Monitoring Platform.
Furthermore, CluePoints can provide Data Scientists to do all the heavy lifting and work with the study team to support plans to identify and resolve issues and document what’s been done to mitigate the risks.
“We are delighted to reveal our new CluePoints Post-COVID Trial Assurance Solution to offer continued support to the clinical research community that has been working so hard to maintain progress in developing new treatments and therapies to improve, protect, extend, and save lives during this pandemic,” says Patrick Hughes, Chief Commercial Officer and Co-Founder of CluePoints.
“This new solution provides another tool in the armory for study teams to take what we have learned during the pandemic and apply it to the many ongoing trials that are still affected.”
“Risk-Based Monitoring remains of central importance to help Sponsors and CROs predict and manage risk at an early stage so that monitoring resources can be prioritized based on actual need.”
The Post-COVID Trial Assurance Solution includes (subject to expert consultation as to what will work best on your specific study or studies):
- Comprehensive Central Statistical Analysis
The comprehensive statistical analysis provides a complete unsupervised analysis of all clinical data to uncover unknown risks in your trial
- Key Risk Indicators (KRIs)
By harnessing the power of statistical algorithms, the Key Risk Indicator module provides a convenient way to monitor how sites are performing versus the metrics that are important to the trial
- Patient Profiles
By coupling Patient Profiles with Central Statistical Monitoring, patients can be ranked by their relative degree of atypicality, allowing clinical teams to get the patients that need it reviewed faster
- Duplicate Patients
If the existence of ‘Professional Patients’ participating in the trial is a concern, CluePoints’ Duplicate Patients module can identify them so that any sign of enrolment abuse can be investigated and addressed.
For more information on the Post-Covid Trial Assurance Solution, please visit the CluePoints website here to schedule a free no-obligation consultation.
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.