Digital Health CRO
AstraOne partners with digital health, DTx, and AI teams to generate the clinical evidence regulators and payers require — from feasibility through pivotal validation.
What we deliver
Digital therapeutics validation
PDT and DTx pivotal trials with active or sham controls, blinded outcomes, and PRO-based endpoints.
Mobile health (mHealth) research
App-based studies, ecological momentary assessment, and passive sensing protocols.
Digital biomarker validation
Analytical and clinical validation of digital measures per V3 and FDA guidance.
Digital endpoint validation
Fit-for-purpose endpoint qualification for regulatory acceptance.
AI and ML clinical validation
Prospective clinical validation of AI/ML algorithms with locked models and pre-specified performance criteria.
Decentralized clinical trials
Fully remote and hybrid DCT execution with eConsent, ePRO, and televisit workflows.
Built for regulatory-grade evidence
- FDA guidance-aligned digital endpoint strategy
- eConsent, ePRO, eCOA, and televisit tooling
- Regulatory grade data pipelines for AI/ML submissions
- Payer-ready real-world evidence design
Frequently asked questions
What does a digital health CRO do?
A digital health CRO designs and executes the clinical studies required to validate digital therapeutics, mobile health apps, digital biomarkers, and AI/ML software — producing the evidence needed for FDA clearance, payer coverage, and market adoption.
Ready to scope your study?
Talk to our clinical operations team about protocol design, recruitment, and execution.