I know what you’re asking, “Is this a marketing turn-of-phrase or an attainable outcome?”
A Medical Monitor’s top priority is to protect clinical trial subjects by monitoring safety signals in the data. To that end, what are your medical monitor’s processes and what technology are they using to ensure focused medical data review, increased subject safety, and accelerated productivity?
- Are your medical monitors alerted to new Adverse Events, data patterns/trends/outliers, and other safety signals in your trials immediately upon data refresh?
- Are your monitors gaining useful, thorough, and quick medical context with only Excel line listings?
- Are your monitors systematically tracking their review progress?
If you answered no to any of the previous questions, it’s imperative you read on.
With the constant pressure of decreasing trial timelines, it seems as if there simply is no ethical or efficacious way to generate time savings in medical data review while maintaining subject safety.
Or is there?
Let’s peel back the medical data review onion a bit.
Medical Monitors have to sift through tons of trial data. This is a very tedious and time-consuming process. Looking for those critical data, finding signals/trends/patterns/outliers and then adding the necessary context through analysis is a huge challenge.
Enter the medical data review process and analytics game changer, Signals Medical Review.
Alerts – At the outset of the trial and during, add customized Alerts based on your specific cohorts of interest. These can be broad cohorts for AEs or targeted, specific lab results for correlations. These alerts can be based on therapeutic area, protocol, intervention and intuition.
Analyze – Look across specific domains and analyze trends, outliers, safety and more with powerful advanced analytics from Spotfire. Having Spotfire embedded directly into the solution, you benefit from an easy to analyze set of visualizations that give you unparalleled context.
Review Tracking – With Signals Medical Review, monitors can now mark their listings as “Reviewed” or “In process” and add threaded narratives to collaborate with colleagues. Everything that happens in the review step is tracked and documented through an audit trial.
- Say what you’re going to do.
- Do what you say you’re going to do.
- Document what you did.
Isn’t this the axiom that regulators live by?
Observe Dr. Anthony (Todd) Everhart performing medical data review using Signals Medical Review. Leveraging medical data review workflows, Spotfire analytics, and documented review tracking to never miss a safety signal.