Ensure your clinical trials are purposefully built for your needs. Join IQVIA eCOA expert Anthony Mikulaschek to explore 3 in-depth cases where best-of-breed technologies were used as building blocks to drive clinical endpoints.

 This presentation will explore the practical applications of AI/ML technology in clinical operations including data acquisition, management, and biostats, with a particular focus on the use of natural language processing (NLP). NLP can be used to extract information from study documents such as protocols and populate downstream data management systems. This has several benefits, including streamlining data operations processes, ensuring data accuracy and integrity, enabling faster data analysis, and increasing automation.

Traditional paper consent is known to be suboptimal. eConsent can present consent content in an enhanced way, which may result in a more effective and patient-centered approach to the process. The unexpected, positive findings of a qualitative evaluation of enhanced vs. a simple text based eConsent will be presented.

Aparito and Garmin Health unveil their work to conceptualise digital endpoints for clinical trials with a focus on both the patient and research perspectives.

The proliferation of digital health devices, such as mobile health apps, wearable sensors, and various consumer goods, show great potential for improving human health. Smartphones offer a large variety of sensor-based technologies, which enables the capture of active and passive real-time data in free-living settings that may fundamentally shift traditional paradigms of clinical monitoring. Clinical assessments of patients might be episodic and may miss important features of functional variations between medical visits. In this context, user experience plays a key role in the success of mobile applications as it is UX that motivates for further engagement and should be considered to design better products. UX factors have attracted increasing attention for the design of healthcare and medical devices since they provide important rational requirements to enhance usability, adherence, user perception and satisfaction. Different UX patterns may lead to different product design, and different UX design may be more effective for some users and in particular situations. In such settings, user experience goes beyond the reliable functionalities and effective usability.

Dr. Patrick Short will explore the rising field of precision medicine research, which continues to present new hurdles as it evolves. Patrick will emphasize successes of biomarker-driven drug development and discuss common challenges, such as patient recruitment, biomarker testing, and patient engagement. A thoughtful framework to streamline recruitment, accelerate enrollment, and reduce costs will be presented, with real-world case studies to demonstrate the effectiveness of this approach.

Regulatory bodies are demanding greater accessibility to trials, leading sponsors to ask for these functionalities in clinical trials. Although accessibility supports inclusivity, to date these recommendations have not truly materialised into actions. No appropriate scientific validation has been done to assess any potential impact on data integrity.

We will present the results of Clario’s industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences.

Clinical trials and drug development processes require strict adherence to regulatory guidelines. The submission of reports and safety data asks for a specific E2B format. Our customer needed an EDC agnostic safety notification to monitor ADRs outside of the scope of a full PV system. We will present how a safety notification solution can bridge the gap between a simple reporting and a PV system with cross study reporting.