Streamline analytical validation and accelerate the adoption of digital health technologies

These resources were built to help you establish a clear decision process for designing and conducting analytical validation studies, and take the uncertainty out of your regulatory interactions.

Whether you’re looking to establish a novel digital clinical measure or implement an existing measure in a new context of use, have a clear statistical analysis plan in mind or need a little bit of time to consider your strategy, are seasoned at interactions with regulators or only getting started, the resources will guide you step-by-step.

DHT developers

Accelerate your analytical validation studies and streamline your interaction with regulators

Resources designed for DHT developers

Interactive Guide to Validating Novel Digital Clinical Measures

Begin with the interactive guide, which walks you through the steps to:

Establish your study objectives and context of use
Select rigorous and fit-for-purpose reference measures
Assess the effect of your intended use environment
Consider when and how to engage regulators

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Build Your Study: Novel Digital Clinical Measure Analytical Validation Planning

Next, follow the steps in the study builder to:

Design a rigorous analytical validation study for your digital clinical measure of interest
Use the workbook format to document your study plan
Present your study plan and results to regulators and other stakeholders

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