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Clinical development planning & trial design

Make critical design decisions before they become costly to change

Misaligned target product profiles, late go/no-go criteria and optimistic patient population assumptions can undermine a programme long before readout. This hub helps clinical development teams surface those decisions early, challenge the assumptions behind them and design trials around the questions that matter most.

Download the TPP template

Start here: the TPP Template

A target product profile structure that drives decisions: target and minimally acceptable profiles side by side, every claim linked to the evidence that must exist to support it. The decision criteria column is the part most teams skip, and the part that makes a TPP actually useful. Free, and yours to keep.

Download the template

The Estimands Playbook

The E9(R1) framework in plain language, with protocol wording that survives review.

Get the playbook

The Cost of Delay Index

Original research on what a month of delay costs at each phase, with the calculator to run your own numbers.

Get the calculator

Brief: Six decisions before the pivotal

Six decisions fix your asset's value, and all six are taken before the pivotal enrols a patient. Four pages, free.

Get the brief

Watch: the video series

Latest from this hub

Design for the label you want, not the trial you can run

Design for the label you want, not the trial you can run

The mindset shift that separates programs built backwards from the label and programs built from habit.

Read the article
Endpoint selection regulators and payers accept

Endpoint selection regulators AND payers accept

A deep dive on choosing endpoints that clear both hurdles, because approval alone does not pay for the program.

Read the article
From TPP to CDP without the guesswork

From TPP to CDP without the guesswork: a worked example

A worked example of turning a target product profile into a clinical development plan, decision by decision.

Read the article
Same trial, two right answers: the estimands framework in plain English

Same trial, two right answers: the estimands framework in plain English

The estimands framework in plain English: pin down exactly what your trial is measuring before the protocol locks.

Read the article
Basket, umbrella, platform master-protocol design

Basket, umbrella, platform: which master-protocol design a single-asset biotech can actually sponsor

Which master-protocol design a single-asset biotech can realistically sponsor, and what each one asks of you.

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Powering your first efficacy trial

Powering your first efficacy trial: stop defending the number, start reading the curve

Stop defending the sample size and start reading the curve when you power a first efficacy trial.

Read the article

Is your design close to final?

A pre-lock design review is outside eyes on the protocol before the money is committed. If your design is weeks from locking, that is exactly the right time to talk, not after.

Book a design review
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