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regulated clinical trials

clinical research, digital endpoints, digital measure, wearables, digital transformation, real-world environment, regulated clinical trials, patient centricity

Reflecting on a Year of Transformative Advancements in Digital Health

As we embark on another exciting year for the digital health landscape, I wanted to take a moment...
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medical-grade wearables, digital measure, regulated clinical trials, physical activity, Obesity

Measuring Critical Health Outcomes Beyond Weight Loss in GLP-1 and Related Obesity Treatments

New weight management medications, such as GLP-1 receptor agonists, have dramatically altered the...
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sleep, medical-grade wearables, digital measure, regulated clinical trials, psychiatry, rheumatology

Sleep: A Meaningful Aspect of Health That’s Overlooked in Clinical Trials

Sleep is a complex and multifaceted physiological process. In humans, not only is sleep required...
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digital biomarkers, digital endpoints, wearables, regulated clinical trials, FDA guidance, digital clinical outcome assessments

Navigating the FDA DHT Guidance: Perspectives from Across the Industry

Digital health technologies (DHT) can collect objective, multi-dimensional data passively and...
8 Minute Read
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digital endpoints, fit-for-purpose, regulated clinical trials, DHT Operations, data quality, FDA guidance, AI

Planning Ahead: 5 Best Practices For The Integration of Wearables in Clinical Trials

Wearable, sensor-based digital health technologies (DHTs) can help biotech and pharma teams...
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digital biomarkers, digital endpoints, algorithms, wearables, regulated clinical trials, Parkinson's Disease, digital clinical outcome assessments

Address Unmet Measurement Needs in Parkinson’s Disease with Wearable DHTs

Clinical development is a challenging task. Clinical development in Parkinson’s disease (PD) faces...
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Data Science, Algorithm, regulated clinical trials, data quality, FDA guidance, AI

Demystifying AI: A Review of the Fundamentals and Applications in Drug Development

Artificial Intelligence (AI) has recently become a household term, with its influence permeating...
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digital biomarkers, algorithms, Data Science, wearables, regulated clinical trials, DHT Operations, FDA guidance, digital clinical outcome assessments

Wearable DHT 101: Foundations for Use in Regulated Clinical Trials

Innovation is exciting, but it can also come with challenges; innovation in the life sciences...
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digital endpoints, sleep, usability, scratch, fit-for-purpose, real-world environment, regulated clinical trials, patient centricity

Evaluating Usability and Incorporating the Patient Experience in DECODE-Nocturnal Scratch

The Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) Nocturnal Scratch...
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DiMe, clinical research, digital endpoints, sleep, scratch, real-world environment, regulated clinical trials, patient centricity

Developing a Patient-Centric Measure of Nocturnal Scratch: A Q&A with DiMe

The adoption of wearable Digital Health Technologies (DHTs) to measure outcomes of interest in...
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clinical research, digital endpoints, digital measure, wearables, digital transformation, regulated clinical trials, patient centricity

Perspective on the FDA's Final Digital Health Technologies Guidance

Regulatory guidance plays a pivotal role in shaping the ecosystem of clinical research and...
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decentralized clinical trials, algorithms, DHT, digital transformation, containers, fit-for-purpose, real-world environment, regulated clinical trials

ActiGraph DHT Platform Upgrade for Agile and Robust Algorithm Implementation

Digital transformation in healthcare and clinical research has been slower to progress than in...
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