The IB, kept in sync with the evidence.
Asthra drafts ICH E6(R3) Appendix A–structured Investigator's Brochures from your nonclinical and clinical data. Toxicology margins, human pharmacokinetics, and the reference safety information stay consistent across subsections — and every update tracks as the program evolves.
What you bring to the draft.
Asthra works from the safety and pharmacology package your program has already generated.
Nonclinical Study Reports
Pharmacology and toxicology — single- and repeat-dose. Asthra extracts NOAELs, margins, and findings.
PK / ADME Data
Animal and human pharmacokinetics, metabolism, and popPK modeling for the effects-in-humans sections.
Clinical Safety Data
Prior Phase 1/2 exposure and adverse-event tables — coded to MedDRA, summarised by SOC and grade.
Prior IB Version
The last edition. Asthra tracks changes forward, flagging what regulatory feedback has moved.
Mechanism / Literature
Mechanism of action and comparator data informing the introduction and risk context.
Your IB Template
Asthra writes into your house template — numbering, headings, and summary tables preserved.
From the safety package
to a synchronised brochure.
Upload & classify
Drop your nonclinical reports, PK data, clinical safety tables, and the prior IB into the project. Asthra classifies and indexes each.
Approve the plan
Asthra maps each Appendix A subsection to its source data and proposes the reference safety information. Approve once.
Generate the first draft
Asthra drafts each subsection, reconciling toxicology margins with human exposure and keeping adverse-event terms consistent. Gaps surface where data is missing.
Writer review in Word
Refine the risk summary, regenerate a summary table, or check the RSI against the body in the task pane. Every change is logged.
Hand off & version forward
The draft ships with the audit ledger embedded. The next edition reuses the structured state — composed, not copy-pasted.
What changes for the medical writing team.
Manual IB drafting
- −Toxicology and human PK reconciled by hand across distant sections
- −Adverse-event terminology drifts between the body and the RSI
- −Summary tables rebuilt manually from source reports
- −Each new version re-derived from the last by copy-paste
- −Regulatory-meeting changes hard to track across editions
IB drafting with Asthra
- +Nonclinical and clinical findings synthesised in one pass
- +Consistent MedDRA terms across the body and the reference safety information
- +Summary tables generated from cited source data, auditable
- +New editions composed from structured state, provenance carried forward
- +Every claim resolves to a file, page, and passage on click
Pilot Asthra
on a real IB.
30-day pilot. Bring one compound. We'll match Asthra's brochure draft against your existing process — subsection by subsection.