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FDA guidance

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...
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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...
4 Minute Read
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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...
7 Minute Read
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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...
4 Minute Read
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clinical research, DHT, digital measure, wearables, patient centricity, clinical outcome assessment, FDA guidance, patient voice

A New Resource to Help Advance Patient-Focused Drug Development with DHTs

The need to transform the clinical trial process to deliver more effective treatments to patients...
5 Minute Read
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