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Every regulatory position states the date it was current.
Forecasting Software Fits the Curve. The Error Is in the Assumptions.
Most pharma forecast error sits in entry dates, payer decisions and net price; machine learning helps with dense prescription data.
Commercial · 13 min readSynthetic Control Arms at FDA: Agreed in Principle, Untested at Review
FDA agreed in 2020 to consider Medicenna's hybrid synthetic control arm; six years on, the trial still awaits a partner.
Clinical · 13 min readThe Formulary Decision Your Claims Data Cannot See
Health systems run their own formularies; claims data shows the effect late and partially; vendor case studies seldom prove cause.
Medical & access · 13 min readWhat Clinical Trial Tokenization Links, What It Misses and What It Costs
Trial tokenisation links consenting participants to claims through hashed identifiers; two published tokenised linkages reached under half of enrolled participants.
Clinical · 14 min readCase study: Gedeon Richter's Regulatory Intelligence Triage, and What Four Clicks Measure
Gedeon Richter automated regulatory alert triage with Clarivate; the only number is four clicks, and the binding clocks sit elsewhere.
Regulatory · 9 min readCase study: Keeping the MLR Queue Moving, From Triage to Review Built Into Creation
We built MLR triage and orchestration for pharma review queues, and a marketing asset platform with MLR review built in.
Commercial · 11 min read