What FDA Inspectors Will Ask About Your AI
AI governance in drug development has been framed as a submissions problem. The first hard questions may arrive earlier, inside GCP inspections, through expectations that already exist today…
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Thoughts on clinical development, regulatory strategy, AI in healthcare, and leadership.
Awareness Is Not Readiness: What BIO Asia–Taiwan 2026 Taught Me About AI-Ready Clinical Development
AI readiness is not built inside the four layers of your operating model — it is built at the seams between them. A field guide to the handoffs where readiness breaks, and the hidden cost of the readiness debt your best people have been quietly absorbing…
Read MoreFDA's Real-Time Clinical Trials: The Shift From Data Submission to Signal Readiness
The FDA's RTCT initiative is more than a technology pilot. A look at what continuous, real-time signal sharing means for clinical development organizations, RBQM operations, and the future of regulatory interactions…
Read MoreThe Protocol Operating Model Is Changing: A Readiness Test for Clinical Development Teams
A practical convergence guide for ICH M11 structured protocols and ICH E6(R3) quality-by-design expectations — including a 10-point readiness test and downloadable scorecard…
Read MoreDigital Twins in Pivotal Trials: Are We Ready to Replace Placebo Arms?
How AI-generated digital twins are reshaping pivotal trial design, with analysis of regulatory milestones, industry adoption, and the ethical case for rethinking placebo arms…
Read MoreFamily Pride: The New Chair of the Internet Architecture Board
My sibling Dhruv Dhody has been selected as the new IAB Chair. The shared values behind internet governance and AI-driven clinical research modernization…
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