The cloud has made anywhere/anytime, centralized monitoring (adaptive-on-site and off-site) of all risk-related trial factors a seamless reality. Looking ahead, the cloud can integrate centralized monitoring, risk management measures, and predictive analytics. It can also create risk repositories, to keep trial costs in check and optimize better quality results for life saving therapies.
As pharmacovigilance adopts next-generation technology by leveraging artificial intelligence (AI) and the cloud, new possibilities are opening up for knowledge generation – and thus value – from the data collected and processed. This paper looks at three important developments around drug safety data and their analysis and how industry is prepared for them.
In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance. Here, we summarize the differences between the two documents and highlight any significant new elements introduced in the most recent material. Of note, the 2018 guidance is more compact and streamlined than its 2010 predecessor, also evident by a fewer number of total pages (36 vs. 50 in the 2010 version).
Like any relationship, the theme to a long and healthy one always boils down to communication. In part 2 of this series, here are five more investments in communication that help Trial Interactive stay in sync with the growth of our users.
Voice Assistant technologies provide an opportunity to create a different level of engagement and interaction in comparison to regular apps and web pages. In addition, voice-controlled applications may remove barriers to use, particularly for those that find operation of a mobile device difficult or fiddly, or have low functional literacy.
The shift of clinical assessment from the controlled environment of a trial site to the uncontrolled environment of a patient's home is a considerable challenge. Read about ICONs creation of a suite of wearables that could be combined and deployed in a non-clinical setting and tailored to specific therapeutic areas.
This poster reports a framework for the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors. Wearable technology is a key component in the design of more patient-centric clinical trials.
Although the benefits of implementing Digital Health technologies into clinical trials are widely acknowledged, the integration of these technologies into trial designs can be burdensome to participating patients. Here, we discuss how adopting a unified patient experience can overcome the various challenges of integrating Digital Health into trials.
How to develop and deploy novel technologies to reduce patient burden and increase engagement.
Mismanaging clinical supplies can threaten study outcomes, bring studies to a halt, and even jeopardize a clinical research program. This article outlines a solid clinical supply management program, defines interactive response technology (IRT) and its role in clinical supply management, and explains how implementing it can reduce risks and costs.
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