Writing
Feasibility, argued in the open.
Method notes on how a feasibility answer should be built, checked, and disagreed with. No invented statistics, no case studies we cannot name — if we cannot source a number, we make the argument without it.
Every claim traceable, here too
All posts
The archive
Guide
Precision Medicine Trial Design: Navigating Master Protocols and Biomarker-Driven Strategies
Precision medicine clinical trial design in 2026: how to choose between basket, umbrella and platform master protocols, pick biomarkers, and de-risk enrolment.
Guide
Real-World Data for Clinical Trial Feasibility: A 2026 Guide to Sourcing and Application
How to source and apply real-world data for clinical trial feasibility in 2026: data providers, AI analysis, FDA/EMA expectations, and best practices.
Guide
Navigating ICH E6(R3) in 2026: A Sponsor's Guide to Risk-Based Quality Management
ICH E6(R3) implementation for sponsors in 2026: proportionality, risk-based quality management, data governance, CRO oversight and inspection readiness.
Guide
Navigating Go/No-Go Decisions in Early-Phase Clinical Trials: A Data-Driven Framework
A quantitative framework for go/no-go decisions in early phase clinical trials: pre-specified criteria, biomarker evidence, and staged risk mitigation.
Guide
Optimizing Patient Recruitment in 2026: Beyond Traditional Approaches
Most recruitment advice is a channel list. Here's what actually moves enrollment in 2026 — eligibility design, EHR pre-screening, and weekly screen-fail math.
Guide
Adaptive Trial Design in 2026: Balancing Flexibility and Regulatory Rigor
Adaptive trial design in 2026: FDA expectations, master protocols, Bayesian methods, and when flexibility helps or hurts your go/no-go decision.
Guide
AI in Clinical Trial Feasibility: Separating Hype from High-Impact Tools in 2026
AI clinical trial feasibility in 2026: which tools genuinely cut enrolment risk, which are repackaged reporting, and how to evaluate vendors before you commit.
Bid defence
What a CRO bid defence needs
The bid defence is won or lost on one question asked five different ways: where did that number come from? Here is how to make every figure in a feasibility pack answerable.
Cohort
Eligibility criteria are a cohort tax
Every criterion is added for a good reason and priced as if it were free. The arithmetic is multiplicative, the cost is invisible at the point of decision, and nobody in the room owns it.
Operations
Site selection is a data problem
Track record, competition density and the enrolment arithmetic are all measurable from public records — and the most common site-selection mistake is a counting error, not a judgement error.
Evidence
Reading a trial’s failure: what “why stopped” actually means
A free-text field on a registry record is doing more work in the industry’s models than almost anything else. Most of what it says is not a failure — and “completed” is not the same as “worked”.
Method
What “probability of success” can and cannot tell you
Ours is directional, and we say so on the number. Here is why an honest directional read is more useful than a precise-looking one — and what a PoS structurally cannot see.
Method
Why most feasibility assessments are unfalsifiable
A feasibility pack that cannot be wrong is not a piece of analysis. It is a document. Here is the difference, and what a checkable one looks like line by line.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.