8 TECH OUTLOOKOctober - 2019IN MY OPINIONTechnology has become an indispensable part of our lives as the convergence of technology trends, from cloud computing and smart devices to 3D printing, machine learning,and the Internet of Things, is leading to an ever expanding digital ecosystem, connecting people, devices, processes, and data. The steady pace of new disruptive technologies continues to transform our personal lives, as businesses also continue to realize increasing efficiencies and cost reductions.The biopharmaceutical industry has in some ways been slow to embrace this new technology wave. But it is clear that increasing efficiencies in the overall development of pharmaceuticals will help bring new and targeted therapies to patients much sooner than the traditional model allows. Technology can be the catalyst that drives these new efficiencies.My colleagues and I recognized that implementing truly real-time data observation, processing, and analysis could dramatically improve the quality and efficiency of our clinical studies.The traditional clinical trial process is labor-intensive and complex, and delayed access to analyze any data emerging from the study is inevitable. Patient consent forms are particularly cumbersome and can lead to regulatory findings if there are errors in the consent process.We wanted to increase the quality, efficiency, and precision of data collected by implementing a single, integrated, and secure automated platform utilizing a unified hub to manage the clinical trial process. This is our digital trial platform, comprised of several components covering the clinical trial approach, from sourcing, consent, scanning, and surveillance. Every component of our platform has been fully tested and validated, is HIPAA compliant and follows FDA guidelines.With our digital trial solution, data flows in real- or near real-time and we can remotely conduct risk-based monitoring of all aspects of the study. The study team can immediately access information on a single digital platform to analyze study performance and collect data from hundreds of sites in multiple countries. Visualization of data is available in real- or near real-time to all study partners to ensure high quality and safety surveillance.This real- or near real-time risk- and remote-based monitoring of clinical data enables opportunity for real-time action. Long transfer wait times are eliminated, data trends, and inconsistencies are quickly identified, duplicate entries are eliminated, data anomalies are addressed instantaneously, trend review, and decision-making are faster, and current and future errors are minimized. A real-time data view also allows monitoring of site/country performance, addressing issues around screen failure rates, and decreases enrollment and randomization of poor-quality subjects. Margaretta NyilasImproving Clinical Studies and Benefitting PatientsBy Margaretta Nyilas, Board Member, Otsuka Pharmaceutical Development & Commercialization. Inc.
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