48 articles and 1,134 case studies on AI in pharma.
Long-form analysis of where AI works in the pharma value chain, and named case studies from the vendors and teams doing it. The 6 marked as guides are the long ones. Every article carries the date its regulatory position was current.
1,182 results
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 readCase study: Account Intelligence for a Supplier That Sells Into Pharma
We built a hub that researches pharma accounts, recommends products, plans outreach and tracks results, ranked by the supplier's strategy.
Commercial · 11 min readCase study: What Launch Intelligence Found Behind a GI Diagnostic Delay
Within3 says pooled advisory boards, congress monitoring and field insights exposed a diagnostic delay. Its page reports outcomes without numbers.
Commercial · 10 min readCase study: Formulary Pull-Through When the Coverage Already Exists
Indegene sent formulary messages to roughly 5,000 HCPs underestimating coverage. The page reports a 3.9% lift but names no control.
Medical & access · 11 min readCase study: Filing CDMO Documents Into a Veeva Vault eTMF While the Taxonomy Keeps Moving
We built eTMF classification for CDMO documents in Veeva Vault: owners edit the taxonomy live, and no model is retrained.
Clinical · 11 min readCase study: The Triage Layer a Biotech Put in Front of Its Safety Database
A 2017 triage layer in front of Argus, read against the reporting clocks it cannot move and today's AI intake.
Safety · 11 min readLaunch Software Watches the First Six Months. The Misses Start Earlier.
Between a third and half of launches miss forecast. Most listed causes are decisions no software makes; forecasts run optimistic.
Commercial · 13 min readWhat Slows Trial Enrolment, and What AI Recruitment Results Actually Measured
Enrolment is mostly lost at the protocol and the site; most AI recruitment studies measured screening speed, not randomised patients.
Clinical · 13 min readHow to Validate a Non-Deterministic LLM Without Pretending It Is Deterministic
Bounded nondeterminism, guardrail qualification, abstention thresholds and revalidation triggers, a complete test strategy for generative systems inside regulated pharma…
GxP, validation & assurance · 17 min readNamed Data Ownership Beats Any Agent
One organisation in fifty-nine is ready; the variable predicting regulatory operations performance is accountability for data, not artificial intelligence. today
Regulatory · 13 min readReview by Exception After Twenty Years of Trying
Pfizer struggled two decades with electronic batch records; costs per site fell eighty percent once leadership changed, not the software.
Manufacturing · 13 min readNinety Percent of Trials Use RBQM. Most Still Run Full SDV.
Nine years of risk-based quality management produced a label, not the monitoring behaviour change that was supposed to fund it.
Clinical · 12 min readNet Impression Is the Standard Your Claim Checker Cannot See
Enforcement now turns on overall consumer takeaway, which claim-by-claim automated review is structurally blind to and cannot reliably prevent today.
Commercial · 14 min readYour Validated Model Has a Retirement Date
Cloud platforms silently upgrade model deployments unless disabled, turning one deployment property into a genuine change-control obligation for validated systems.
GxP, validation & assurance · 11 min readSeventy Percent Recall Is What an MLR Agent Actually Delivers
Reading the published multi-agent review architecture closely: batching, claim verification, reviewer fleets, and the recall-over-precision tuning that raises reviewer w…
Commercial · 13 min readEvery Marketing Authorisation Holder Now Owes a EudraVigilance Signal Duty
The pilot list ended, the notification form disappeared, and most signal management procedures describe a regime that no longer exists.
Safety · 14 min readWhich GCP Clause Actually Governs Your Clinical AI Model
Full-text analysis shows the guideline never names artificial intelligence, so governance assembles from computerised systems, oversight and monitoring clauses instead.
Guide · Clinical · 18 min readHuman Oversight Is a Control You Qualify, Not a Sentence in Your Risk Assessment
Reduced model testing is bought with monitored operator performance; most oversight designs never budget for that second expensive operating obligation.
GxP, validation & assurance · 11 min readCosting a Health Authority Query Response Before You Automate It
Query volume, hours per response, Module 3 hotspots: building a credible automation business case from measured baselines, not vendor claims.
Regulatory · 13 min read