Digital Health Technologies (DHTs) address critical limitations in today’s clinical development paradigm. A growing body of regulatory and scientific evidence demonstrates their reliability, usability, and value across the drug and device development lifecycle. When appropriately validated and deployed, DHTs can enhance the sensitivity of endpoint detection, reduce sample size and study duration, and ultimately improve the probability of demonstrating a treatment effect.

At qointa we help you navigate the complex regulatory, operational, and scientific landscape to design and execute an optimal DHT-enabled clinical study—one that is fit-for-purpose, compliant with global standards, and positioned for regulatory acceptance.

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📄 DHT REGULATORY READINESS IN TRIALS

DHT Landmines: The Hidden Triggers of Regulatory Exposure

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Disclaimer: This document is provided by qointa for informational and educational purposes only. It is intended to support general understanding of digital health technology (DHT) regulatory considerations within clinical research and should not be interpreted as legal, regulatory, or compliance advice.

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