Field notes from the regulated-writing frontier.
Articles, white papers, recorded sessions, and templates from the Asthra team and our advisor network. Written for medical writers, regulatory leads, and the people who hold them accountable.
Writer-defined provenance: a design pattern for regulated AI writing.
How closed-system retrieval, two-level citations, and append-only ledgers compose into a deterministic accountability stack — and why “trust” without these primitives is just marketing.
Read the white paper →Why "human-in-the-loop" isn't enough — and what to require instead
HITL is necessary but not sufficient for regulated writing. The missing piece: gated approvals at the right points in the loop.
Read article →Citation graphs that hold up at audit
Document-level vs. sentence-level provenance, and what a notified body actually verifies. With sample queries.
Read white paper →Inside a CSR pilot: what we measured
Pilot debrief from a top-20 pharma. Cycle-time deltas, writer-time reallocation, QC findings. Recorded session.
Watch recording →Hallucination is a data-flow problem, not a model problem
Why bigger models don't fix factual errors in regulated writing — and what the architecture has to look like instead.
Read article →RFP template: AI tooling for regulated writing
A vendor-evaluation RFP we developed with sponsor and CRO procurement teams. 60 questions, scoring rubric included.
Download template →From 8 weeks to 9 days: a CER cycle-time case study
How a mid-cap medical-device company compressed CER cycle time on a notified-body resubmission. Anonymized data.
Read case study →What ICH E3 asks for that AI consistently misses
Six places generic AI fails to match the structural expectations of a CSR — and what a module-aware writer does instead.
Read article →Aggregate safety reporting: where AI helps, and where it must not
A field guide to applying AI in PSUR / PBRER / DSUR drafting. Co-authored with Varun Dua, PV Analytica.
Read white paper →Module 3, drafted from the batch record
A walk-through of CMC drafting with cell-level provenance. With Q&A from CMC writers and quality leads.
Watch recording →