Unprecedented Data-Monitoring Backlogs & How To Deal With It

Presented by

Kristin Mauri & Rhonda Roberts

About this talk

Recently, industry publications have filled with COVID-19-related clinical trial stories. As biotech and pharma companies the world over the race for a vaccine or a cure, there is another pandemic tale that is going unheralded: the virtual halt to real progress on clinical trials for anything except COVID-19. Though most fully halted trials were just in start-up mode, even trials that have maintained progress face dramatic delays. When operational, each study generates robust pools of data—yet clinical monitors can’t access the sites to conduct their traditional on-site point-by-point verification. Meanwhile, the data continues to pile up. This webinar will focus on: • Rapid Recovery Plan. What types of technology can be used to assess where the most significant risks lie in your study rapidly? • Data Analysis. How the use of anomalous data and fraud detection methodologies can be used to support monitoring backlog recovery efforts. • Lessons Learned. Applying the learnings from a rescue study to the current situation • Future-Proofing your Monitoring Strategy: Assessing short term solution for long term gains The coronavirus pandemic has wreaked havoc on clinical trials at every stage, in every country around the world. As a result, sponsors understanding the value of remote monitoring technologies that many had previously shunned—and such techniques are likely to be broadly adopted in the next generation of clinical trials, bringing speed, efficiency, and higher quality patient outcomes. Their value may first be proven through the adoption of short-term solutions to today’s most pressing problems. With on-site monitoring still largely on hold or occurring at a much-reduced rate the backlogs of unverified data seem overwhelming; such technologies present an efficient means of recovery, enabling sponsors and CROs to mitigate risk, minimize operational disruption, and demonstrate control of their study data. It’s the logical next step for backlogged trials.

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