The 'Creativity Lane' of Clinical Monitoring
Gayle Hamilton, Director, RBQM, Digital Trial Management Suite
Nov 10, 2021

Monitoring aspects of a clinical trial have been costly and very process laden. But, are we stuck forever with our current monitoring standards? This is the first in a series of blogs about Digital Trial Management System Solutions.

Our industry is changing rapidly and it's hard to keep up. It's a challenge to resource a study let alone hope those performing the roles are following the expected operating procedures. Sometimes it feels like we'll never reach the end of the study with any accurate data!

Thank you, World, for COVID changing the face of clinical research! Yes, I really did say that!

We've been stuck in a rut and we don't like change! Well, maybe the pandemic moved us. It's what forced us to start the path down “Creativity Lane”. Sites closed. Subjects didn’t and don't want to endanger themselves. We started asking basic questions and identifying what we thought we had to do. Will we ever be able to finish this trial? We have timelines to follow! We have to SDV!

Or do we? Can we really work only with reviewing critical data? What if we miss data? Will subjects really be safe?

It's ok. It really is.

We want to do it, but we're afraid. Afraid we'll miss data collection that will make a difference in subject safety. Afraid if we don't SDV 100% of the data, we'll come up short with endpoint data. Afraid of the metrics for data backlog!

Can we really reduce our SDV, target critical data and succeed? Yes. In a nutshell. We can do it better than before. And the Regulatory bodies have weighed in and encourage the change!

Technology is our best ally. It's enabling us to see data remotely and analyze it more meaningfully – and faster too! It's giving us risk data at multiple levels. Study. Site. Subject. And more! Setting up site performance metrics to show us who needs attention, who is behaving, added with machine learning to identify critical data outliers.

We have to forge ahead. Find the solution in a system that captures it all and won't break the bank. A system that covers any trial needs, no matter the phase, size, or number of available resources. A system that provides analysis of data you really need. A system that performs ad-hoc analyses per user needs.

You may be asking what does RBQM really mean? RBQM is quality management of an entire trial from systematic integrations to identifying risk through every task and process of the trial. It's knowing you have a system that integrates data from any system, then comprehensively applies intelligence across all trial data to see the true picture.

Does this system exist? Is it forward thinking? Will it cost millions of dollars?


There is such a system!

A system flexible enough to run a trial end-to-end – from trial and protocol design through eTMF completion, despite the monitoring model. Run a trial in a full risk-based approach, Rare Disease, hybrid or decentralized model within the solution.

A technology platform that automates risk planning to minimize missing critical data and integrates it through to operational plans. A solution that is ecosystem agnostic with process-driven workflows, configurable dashboards, and significantly minimizes cost to poor quality. A system that is proactive instead of reactive with intelligent continuous risk identification and assessment improving critical to quality processes.

An intuitive, intelligent, interoperable, and scalable system, that by nature of being RBQM, saves costs, improves quality, applies direction to the real trial needs. It identifies outliers within normal data parameters as well as outside the norm. It continues to advance in technology based on trial and therapeutic findings and analysis. It advocates subject safety. The system that ingests data to provide a detailed to holistic view of the trial. And, it meets regulatory risk requirements. It’s a system that can provide cross-trial data against a portfolio of trials. There’s so much it can do and it’s right for you whether you are a Sponsor or a CRO. It’s the solution!

Next up in the blog series: Conquering the technology and innovation challenges!

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