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 firstname.lastname@example.org. Subscribe >>