Framework
V3 + DiMe
Verification · analytical · clinical
Documentation
End-to-end
Methods, evidence, version history
Submission
Supported
IND · IDE · NDA · BLA · MAA · PMCF
Regulatory Alignment Workflow
Define → Validate → Document → Defend
In clinical research, regulatory alignment for a digital endpoint program is the work that makes the program defensible — to reviewers, auditors, and statistical teams. It is not a one-time review at filing. It is the discipline of building documentation, validation evidence, and provenance into the operating model from the beginning.
Regulatory alignment is a property of the documentation and the operating model — not of the device.
Related pages: Regulatory-Ready Endpoints · Validation
Most digital endpoint submissions stall not because the underlying technology is unsound, but because the validation evidence is missing, partial, or not packaged in a reviewable way.
Reviewers can't accept a metric they can't explain. Opaque vendor algorithms are a hard stop.
Verification done; analytical validation thin; clinical validation absent. Submissions need all three.
An algorithm that changes silently mid-study leaves reviewers unable to trust comparisons over time.
Values arriving without device, firmware, and algorithm-version context can't be re-analyzed.
Strong validation against the wrong clinical question doesn't help the submission.
Documentation written after the trial is harder to defend than documentation built alongside it.
Regulatory alignment is something you build in from the beginning — not bolt on at filing time.
We don't replace your regulatory team — we give them an organized, defensible package to file.
Programs that hold up under regulatory review are organized for review — not just for data collection.
When the package is organized, the conversation with reviewers stays focused on the science.
See related pages: Security & Privacy · Validation · Endpoint APIs
Delve tracks the frameworks reviewers actually use — and updates validation patterns as those frameworks evolve.
Methodology aligned with current FDA guidance for digital health technologies in clinical trials.
Endpoint methods take EMA qualification opinions and scientific advice into account.
Verification, analytical, and clinical validation patterns follow the Digital Medicine Society V3 framework.
Electronic records and signatures handled in 21 CFR Part 11-compliant infrastructure.
Endpoint operations follow ICH GCP principles for clinical investigation.
Immutable audit trail, scoped access, and documented procedures for inspections.
We support — we don't replace — your regulatory team. The submission still belongs to your filers.
Acceptance is decided per submission. What Delve provides is a documented, defensible package containing the evidence reviewers ask for. Your regulatory team owns the submission strategy.
Consumer 'validation' typically refers to the sensor. Regulatory-aligned endpoints require validation of the full chain — sensor, algorithm, clinical interpretation — documented in a way reviewers can audit.
Yes. We'll join pre-submission meetings or sponsor briefings to walk through the digital endpoint package if that helps your regulatory team.
Delve develops digital endpoints with the documentation, validation, and version control your submission teams need from day one — across pivotal, post-market, and real-world programs.
Book a Regulatory Discussion