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A new class of best practices for clinical trial monitoring

Tuesday, March 1, 2016

Until recently, real-time study vis­ibility into milestone drivers such as enrollment, data quality and patient compliance was virtually im­possible to obtain. Spreadsheets have served their time as the go-to manual computation and compilation tool. With the growth in the number of clinical systems per trial, spreadsheets can no longer keep up with the data aggregation and insight needed to minimize risk and cost. The minute data is entered into a spreadsheet, it begins cooling.

“What is the status of my study?”

“How is enrollment plan versus ac­tual on our critical studies?”

“Which sites require additional monitoring?”

“Why are protocol deviation and AE rates increasing?”

Hard questions to answer when outliers aren’t evident; even harder when there’s no way to drill down into the spreadsheet to determine why a particular study or site is at risk. ClinOps executives, teams, managers and CROs have no way to oversee the status of even the most critical studies. Teams are in reactive mode, which introduces avoidable operational and regulatory risk, and unnecessary cost.

Fortunately, cloud-based portfolio monitoring solutions are resolving dat­ed approaches to milestone achieve­ment. Offering continuous visibility, monitoring, forecasting and collabora­tion, automated solutions allow the ex­tended team to act faster, focus on what matters, and make collaborative op­erational decisions. Sponsors can pro­actively eliminate delays that threaten timely milestone achievement, enroll­ment and data quality—the most obvi­ous drivers of cost overruns.

Enrollment, patient compliance and data quality are the milestone fo­cus areas for the automation behind portfolio monitoring solutions. Built with adapters that integrate and nor­malize all relevant data, user-friendly visualizations and compelling analyt­ics and forecasting capabilities, con­tinuous monitoring solutions track these critical aspects of study perfor­mance in real-time. Minute devia­tions are evident, automatic alerts are delivered to the appropriate individu­als for analysis and problem-solving.

Today’s cloud-based solutions put the power of technology to work to create the certainty study leaders seek. Their availability ushers in a new era of best practices, and a new definition of the speed to quality results.

 

Written by Guest Writer Rick Morrison. Morrison is Chief Executive Officer of Comprehend Systems, a leading provider of clinical trial management solutions, where he is responsible for the company’s overall direction and management. A graduate of Carnegie Mellon University, Morrison has over 15 years of experience developing clinical analytics tools, including solutions used by the FDA and top pharmaceutical companies. Morrison has been named to the PharmaVOICE 100, recognizing the 100 most influential people in the life sciences industry. www.comprehend.com

This article was reprinted from Volume 23, Issue 03, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.comSubscribe >>

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