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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

digital biomarkers, algorithms, Data Science, wearables, regulated clinical trials, DHT Operations, FDA guidance, digital clinical outcome assessments

Innovation is exciting, but it can also come with challenges; innovation in the life sciences...

4 Minute Read

digital endpoints, sleep, usability, scratch, fit-for-purpose, real-world environment, regulated clinical trials, patient centricity

The Digital Endpoint Collaboration to accelerate Outcome DEvelopment (DECODE) Nocturnal Scratch...

4 Minute Read

DiMe, clinical research, digital endpoints, sleep, scratch, real-world environment, regulated clinical trials, patient centricity

The adoption of wearable Digital Health Technologies (DHTs) to measure outcomes of interest in...

5 Minute Read

clinical research, digital endpoints, digital measure, wearables, digital transformation, regulated clinical trials, patient centricity

Regulatory guidance plays a pivotal role in shaping the ecosystem of clinical research and...

2 Minute Read

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

As we embark on another exciting year for the digital health landscape, I wanted to take a moment...

2 Minute Read

decentralized clinical trials, algorithms, DHT, digital transformation, containers, fit-for-purpose, real-world environment, regulated clinical trials

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

2 Minute Read