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Case studies, research and perspectives from the work, including the first results from Protocol Authoring, written by the people who did it, with the numbers we can stand behind.

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Case studies

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Case study

Personalized Medicine & Disease Progression Monitoring

How a longitudinal biomarker platform turned scattered lab values into a per-patient progression signal clinicians could act on.

11 November 2026 · 1 min read
TopicsClinical developmentDiagnosticsHealthcare AIRegulatory affairsRevenue cycle
New in Proto AI · Protocol Authoring

The loop now starts before the protocol exists.

Keep scrolling · the row moves
The writing desk

Most protocol risk is decided on the day the first draft is written, long before a CRO, an EDC build or a site sees it.

Protocol Authoring replaces the blank document with a guided, evidence-grounded workspace. A hypothesis becomes an early-phase draft in hours, structured, cited and compliance-checked from the first line.

01Blueprint

A blueprint, not a blank page

A guided conversation captures phase, indication, endpoints, hypothesis and design philosophy. The study exists as structured data before a sentence is drafted.
02Evidence

References you choose to trust

Comparable protocols are found by indication, phase, endpoints and population, with what worked and what caused friction. You lock the reference set.
03Draft

A draft that checks itself as it grows

SPIRIT and ICH-GCP alignment, endpoint logic and statistical coherence are checked while you write, not at the end.
04Governance

An agent team, a human sign-off

Specialist agents for design, endpoints, safety, statistics and regulatory work in parallel. Every section routes to a named reviewer.
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The Insights letter

New posts, when they are worth your time

Case studies and research from regulated healthcare work. No more than twice a month.

Want this applied to your workflow?

Start with an 8-hour health check or a two-week leakage assessment on your own data.

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