Technology 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-intensiveand complex, and delayed access to analyzeany 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 soultion, data flows in real- or near real-time and we can remotely conduct risk-based monitoring of all aspects of the study.