CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.
This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
A major component of convergent development, combination treatment approaches―which unite two or more different types of regulated drugs or medical devices to enhance patient outcomes―and their supporting trials, provide a chance for each industry to leverage a mutually beneficial partnership to help ensure their respective products stay on or are approved for market.
This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines.
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In September 2018, FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaces the previously published 2010 draft guidance.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.
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