TECH OUTLOOKOctober - 20199With real-time data analytics available, site visits are more strategically focused on site needs and addressing identified risks and sites needing more support, while ensuring GCP compliance and proper protocol adherence. Data quality is enhanced for all subjects through ongoing review of safety and scale data, demand is reduced on both sites and patients, and compliance is increased on all levels.The way our automated system allows us to so closely monitor the study performance was simply not possible before, and activities that once took 6-12 weeks are now being reduced to just a few days. The reduced timelines mean we can obtain regulatory approvals and provide new drugs to patients much sooner. For study participants, the platform provides a mechanism to enhance patient engagement through targeted patient-facing videos and content to ensure the patient understands the demands of the trial. The entire consent process is greatly simplified for the patient. Additionally, the use of digital sensors and electronic diaries reduces burdens on study volunteers by allowing them to provide real-time data electronically. Importantly, real-time patient data improves patient safety by allowing for faster and more precise data review and ensuring the right study compound is being administered to the right patient.We began piloting two components of the digital trial suite in 2012. Now, two trials utilizing the full platform have been completed. The full digital platform will be the standard for all studies initiating in the third quarter of 2016 forward. Two Phase 3 trials are live, with two Global Phase 3s starting this summer. All additional studies planned over the next 18 months will be utilizing the full platform.Implementation of the digital platform was enthusiastically embraced within our organization. With the many benefits that the digital platform offers, our study teams have become full and active participants in our innovation R&D culture. Software has become a new core competency within our organization. By re-engineering our internal capabilities into one integrated system, the execution of true paperless trials and submissions is becoming a reality.We are excited to be pioneers and leaders in the effort to bridge healthcare and the power of digital technologies. What keeps us continually motivated to further advance the frontiers of innovation is knowing that our efforts help serve patients by developing new treatments for their needs faster and more efficiently. Near real-time risk- and remote-based monitoring of clinical data via innovative digital platform enables opportunity for real-time action
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