Blog
Risk-based monitoring, risk-based quality management, risk-based blah, blah, blah, and Quality Risk Management (QRM)! What is all the uproar about risk?
Gayle Hamilton, Director, RBQM, Digital Trial Management Suite
Jun 02, 2022

A few questions to ponder… Do you feel like your trial will be more at risk if you cut out 100% SDV or CRAs visiting sites every 6 weeks? What if we don't catch missed adverse events or something more important? SAEs, Quality Issues? Are there higher risks with the risk-based approach? Well… what if the system you were using automates the data with traceability well enough that these potential issues are mitigated?

Gone are the days of subjects having to come into the office to complete all assessments – manually, more often than not.. Thank goodness as this eases subject and site burden and allows for increased enrollment opportunities in a trial. The ability to adapt as a result of a pandemic has accelerated clinical trials into a new paradigm. The MHRA has even come onboard stating, "The ICH GCP statement that, 'in general there is a need for on-site monitoring before, during and after the trial' is not recommended to be interpreted that on-site visits for assessment, initiation and on-going monitoring and closeout must always be performed."1Wow, does this open the door for a risk-based approach and for all of us to feel more comfortable?!

With a risk-based approached, the number of monitoring days onsite are reduced easing site, trial cost and sponsor burden. Gone are the days of queries being open for months on end. Sites are being held to contract agreements for data responsibilities - or at least they are getting notified of breaches more expeditiously than in non-risk based approach trials, leading to a happier project team. Well one less disheartening issue to deal with, at least!

Did you catch that key word earlier? Automation! The SaaS-based cloud system starts with Quality by Design at the Protocol Design step, however, can be implemented even later for trials already being conducted. Starting with libraries of therapeutically aligned configurable risks leveraged by IQVIA's over-12-years-of-risk-based experience, the system enables Integrated Monitoring across all of the roles that need to monitor data within the trial with insight as to what other roles are monitoring. Oversight is at the forefront of every trial.

Reviewing data at the Trial, Site and Subject levels provides the holistic data needed to identify the trends and issues triggering site contacts (queries, tele-visits, et al.), remote and/or onsite monitoring visits (and the MHRA condones it!). Issue identification enables dynamic, quality monitoring. It doesn't mean a site is not monitored, rather it's monitored for all of the data on the trial risk plan through the integrated monitoring strategies and based on the risks identified both predictive and actual. Issue prevention is paramount! Can you imagine being able to identify the majority of protocol deviations at the beginning of the trial and how prompt remediation can reduce ongoing deviations? The overall numbers of protocol deviations in a risk-based approach are significantly less- 50% less- as documented through IQVIA's proof points.

Data literacy of the data intelligence is system guided as well as supported by project advisory, if needed. It simplifies the reliance on self-taught and potentially inaccurate evaluations. User friendly and configurable analytics support trend and issue identification at all levels, whether reviewed through a medical team vs data management vs a CRA.

Use a SaaS based product configured to your staff, your way. It's an end to end solution which integrates with Customer systems, fits any trial size, and is your opportunity to run your own trial!


1MHRA's Guidance Oversight and monitoring activities

Related solutions

Contact Us