Thoughts on clinical development, regulatory strategy, AI in healthcare, and leadership.
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 MoreThe 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 MoreA 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 MoreHow 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 MoreMy 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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