What we are seeing, what we are thinking, and what it means for clinical research and life-science market entry.
These pieces are written from operational experience — not from conference panels or vendor briefings. They reflect what we are actually seeing in clinical trials, market entry engagements, and physician innovation programs.
We have been running agentic AI on live clinical trials since 2024. Here is what actually happened — the wins, the failures, and the things we did not expect.
After running the 90-day market entry program for companies from 12 countries, the same mistakes appear in the same order. Here they are.
Seven years of running DIUP has given us a detailed picture of where clinician-innovators get stuck. The answer is not what most people think.
What FDA has said, what it has not said, and what our experience submitting AI-assisted documents tells us about where the line is.
Companies that get EU regulatory approval and then discover the reimbursement landscape have made a sequencing error. Here is how to avoid it.
Why clinical trials are slow is not a mystery. The work is serialized. Here is a precise description of the problem and what collapsing it actually requires.
We publish infrequently and only when we have something worth saying. Send David an email to be added to the list.
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