Protocols that hold together — section to section.
Asthra drafts ICH M11–structured clinical trial protocols from your concept, IB, and analysis strategy. The estimand framework, schedule of activities, eligibility criteria, and dose justification stay aligned across the document — so a change in one section ripples cleanly through the rest. Starting from scratch? Our seed-generated protocol synopsis turns a one-line indication into the synopsis that seeds this protocol.
What you bring to the draft.
Asthra works from your development concept and the evidence that justifies the study.
Study Concept / Synopsis
Objectives, target indication, and design intent. Asthra expands it into the full ICH M11 structure.
Investigator's Brochure
Nonclinical and prior clinical data — informs background, rationale, and the benefit-risk assessment.
Statistical Strategy
Estimand framework, population definitions, and analysis intent for the objectives and endpoints sections.
Dose Rationale / PK-PD
Nonclinical NOAEL, modeling, and starting-dose justification for the trial-intervention sections.
Regulatory Guidance
ICH E6(R3), E8(R1), E9(R1) and indication-specific guidances applied as the authoring ruleset.
Your Protocol Template
Asthra writes into your house template — numbering, headings, and styles preserved.
From study concept
to a review-ready protocol.
Upload & classify
Drop your concept, IB, statistical strategy, and dose rationale into the project. Asthra classifies each file and extracts the design parameters.
Approve the plan
Asthra proposes which source each section will draw from — and surfaces the estimand and population definitions that will be reused document-wide. Approve once.
Generate the first draft
Asthra drafts the protocol section by section, keeping the schedule of activities, eligibility criteria, and endpoints internally consistent. Gap flags surface where the rationale is thin.
Writer review and refinement
Most of the time goes here, and Asthra stays in it with you. Resolve the flags it raised, regenerate a section with steering after the design changes, rewrite a highlighted paragraph of the rationale, and compare against a named earlier version. Every change Asthra makes comes back as a Word tracked change you accept or reject. See the full review and refinement flow.
Hand off for sign-off
The draft ships with the audit ledger embedded. When the design changes, regenerate the affected sections and compare against the earlier version.
What changes for the study team.
Manual protocol drafting
- −Estimands and population definitions copy-pasted across sections, drifting over revisions
- −Schedule of activities maintained by hand against the visit narrative
- −Dose justification rebuilt from scattered nonclinical reports
- −Cross-reference integrity depends on the author's memory
- −Amendments require re-checking every dependent section manually
Protocol drafting with Asthra
- +Estimand and population definitions set once, reused everywhere
- +Schedule of activities and eligibility criteria kept aligned automatically
- +Dose justification drawn directly from the cited source data
- +Named versions you can compare and restore when the design changes
- +Every claim resolves to a file, page, and passage on click
Pilot Asthra
on a real protocol.
30-day pilot. Bring one study concept. We'll match Asthra's protocol draft against your existing process — section by section.