Clinical development
Protocol design, site feasibility, recruitment, monitoring, data management and the trial master file — where AI moves cycle time and where it only moves slideware.
- Protocol design & feasibility
- Site selection & recruitment
- Clinical data management
- Risk-based monitoring
- eTMF & document operations
The guide
The long, definitive pieces on clinical. Everything else on this page goes deeper on one part of them.
8 articles
Specific problems, specific answers, each written against a named source and dated.
Synthetic 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 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: 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 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 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 readDigital Twins, External Controls and What EMA Actually Qualified
Prognostic covariate adjustment shrank control arms, but nobody replaced one; Annex 2 now writes real-world control groups into GCP text.
Clinical · 13 min readQuery Economics, Not Model Accuracy, Decides Clinical Data Management ROI
Database lock cycle times lengthened as sources multiplied; reconciliation across third-party data, not electronic data capture, is where automation pays.
Clinical · 14 min readEvery Disclosed AI Cycle-Time Number in Clinical Development, and What Each Measures
Novo Nordisk, AstraZeneca, Novartis and AutoIND figures compared, with the drafting-versus-approval distinction that nearly every published business case quietly ignores.
Clinical · 14 min read