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Integrated clinical monitoring – technology enabling data to talk!
Gayle Hamilton, Director, RBQM, Digital Trial Management Suite
Feb 17, 2022

What did one piece of data say to another......?

The intel, the ease of use, significantly improved quality, hmmm…….

When you think about Integrated Monitoring, what does that really mean? When I think about Integrated Monitoring, it sounds like it should include technology, for sure. And definitely monitoring. But how do they fit together intelligently and reduce workload- isn't that the goal of each workday?

I remember when I started my first EDC study. It was liberating. No paper cuts from ripping out duplicate pages of data collection and less monitors coming to my site to babysit and answer questions at their whim. Ok outside of you knowing I've been in the industry for a while and for those who can relate, wasn't that a freeing feeling when you worked on your first EDC trial (access and migration issues aside!)? And how far have we come since then in advances in modernizing monitoring technology!

Technology can now work miracles and without technology, we couldn't have integrated monitoring. The ability for the entire project team to see the combined data/findings versus siloed reviews allows for improved issue transparency at several levels. Data accessibility is at our fingertips. The ability to compare and analyze using different applicable algorithms and machine learning when ample data is available leads to more intelligent evaluations and assessments- even predicting where issues are probable.

Integrated monitoring requires a focused and specific risk plan, or as ICH E6 R3 indicates, identifying "factors critical to the quality of the trial," as is targeting the data relevant for each of the clinical trial roles that monitors any data. If they review it, it needs to be documented in the risk plan… but only for the critical data that matters. What if the system can automate both the therapeutic and indication level critical data (CD/P) as well as provide default expected data reviewers for each CD/P? Time, cost, quality, risk intelligence!

Now that the critical data has been identified, then what?

You've heard of Quality Tolerance Limits, right? How can you recognize the data that matters at a glance? With the enablement of most data being captured through technology, remote monitoring in near real time enhances issue escalation with the analysis of data across the trial for broader potential quality concerns. Automation of critical data matters to integrated monitoring. It takes the subjective nature out of the picture and provides objective comparisons. Setting configurable thresholds using business logic allows for easy issue detection; actioning alerts previously assigned to specific clinical trial roles drives faster issue identification and resolution.  And it doesn't take an army to do it! * I'll asterisk this comment and base it on the trial size since we know a mega trial requires more resources than a small trial! *

All of these considerations play into quality. Scrutinizing the data holistically, from the various trial role perspectives, gives the most expansive and comprehensive feedback. The input is important and process matters, too!

What did one piece of data say to another? Seriously…It's not a bad mom joke!

Consider data ingestion. Data needs to be pulled in and "talk" across systems to provide the best analysis. It needs to be coordinated to minimize both audit findings and bias and provide that holistic picture to the cross-functional team- all of whom need to be able to discern the same data from their perspective. Data needs to speak to each other to keep it objective and intelligent. It reduces manual burden (manual burden equals and increase of the risk of mistakes!) and supports end to end trial management as expected with ICH guidance. Regulatory ready!

An end-to-end solution, feeding data across the trial to identify the unknown unknowns. Intuitive, intelligent, interoperable, and a scalable system that saves costs, improves quality, and applies direction to the real trial needs. Are you ready for it? It's ready for you!

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