For well over a year now, the clinical research community has been hard at work to maintain progress in developing new treatments and therapies to improve, protect, extend, and save lives. For many sponsors and CROs, the pandemic has been the catalyst for reassessing pre-existing monitoring protocols to ensure that studies stay on track, particularly when on-site monitoring is off the table. Needless to say, this paved the way for the use of Centralized Monitoring to skyrocket.
And now that things are moving again, we have the opportunity to take what we have learned during the pandemic and apply it to our trials to ensure that we fulfill our mission – to build safer, more efficient trials for our patients. As we are now mid-way through 2021, study teams are asking “With everything we’ve been through, how can I assess the quality of my data? And can I do this within a defined timeline and with limited resources?”
To affirmatively answer these questions, CluePoints introduces:
The CluePoints Post-COVID Trial Assurance Solution
The CluePoints Post-COVID Trial Assurance Solution goes beyond traditional Key Risk Indicators to evaluate ALL (yes, 100%) of the clinical data to assess expected risks while also identifying data anomalies which might indicate unexpected risks – surfacing issues which can only be found by leveraging CluePoints’ Central Statistical Monitoring Platform. Furthermore, CluePoints can provide the Central Monitor to do all of the heavy lifting and work with the study team to create a plan to mitigate risk and document what’s been done to mitigate the risk/s and the improvements that were observed as a result.
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, our Key Risk Indicator module provides a convenient way to monitor how sites are performing versus the metrics that are important to the trial.
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 reviewed, faster.
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.
Free No-Obligation Consultation
If you would like to learn more about the CluePoints Post-Covid Trial Assurance Solution, our risk mitigation experts are on hand to help you. Schedule your free no-obligation consultation via our website here.