General Questions
Asthra AI is a regulatory writing co-pilot that generates compliant first drafts of clinical, safety, and regulatory documents inside Microsoft Word, with writer-defined provenance and sentence-level citations. Asthra automates the mechanical work of documentation while keeping writers in full control of accuracy, compliance, and quality. It is built on Anthropic's Claude.
Asthra is built on Anthropic's Claude. Within a drafting run, Asthra selects between Claude models (Opus, Sonnet, Haiku) based on the task — retrieval, drafting, or review — to balance quality and cost. Customer data submitted through the API is not used to train Anthropic's models.
Asthra currently supports Clinical Study Reports (CSRs — ICH E3), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Drug Safety Update Reports (DSURs), Clinical Evaluation Reports (CERs — EU MDR), and CMC modules (eCTD Module 3). Additional document types can typically be onboarded in a matter of weeks.
No. Asthra accelerates drafting and improves consistency, but writers retain full control and are responsible for review and approval of all content. Asthra is a co-pilot that handles mechanical tasks — retrieval, synthesis, citation — so writers can focus on interpretation, judgement, and regulatory strategy.
How It Works
Two mechanisms. First, a closed-system architecture: Asthra retrieves only from the source documents you provide — never from the open internet, never from the model's training memory. Second, granular context engineering: the agent is given only the relevant excerpts per section, so there is nothing to hallucinate from. When a source gap exists, Asthra flags it inline instead of fabricating content.
Every drafting run follows four steps: Plan, Retrieve, Draft, Hand off. The agent first proposes a retrieval plan (which source files and sections it intends to use for each part of the document). Writers can approve or adjust before the agent spends model calls drafting. The agent then pulls excerpts via semantic retrieval, drafts each section with Claude, and hands off to Word with an immutable transaction ledger embedded in the .docx.
After the first draft lands in Word, chat mode lets writers refine the document in natural language. Ask the agent why a passage was cited, compare two sources, tighten a summary, or swap a source. Every refinement uses the same closed-system retrieval, updates citations automatically, and is recorded in the transaction ledger.
The required source documents depend on the document type. For CSRs: trial protocol, Tables/Figures/Listings, and optional Statistical Analysis Plan. For PSURs: historical PSURs, Core Data Sheet, exposure data, safety line-listings. For CERs: clinical data, literature search outputs, post-market surveillance, prior CERs. For CMC: Batch Manufacturing Records, Certificates of Analysis, specifications, analytical methods, stability data.
Two levels. Document-level: for every section, the source files and sections that were used. Sentence-level: on demand, exact file name, page number, and text snippet behind any claim. An immutable transaction ledger is written into the .docx itself, so the audit trail travels with the document — independent of Asthra.
Yes. Writers edit directly in Microsoft Word with track changes preserved. Writers can also modify prompts, change source selections, and regenerate content. Manual edits are detected and logged as direct edits, so provenance stays honest even when a writer types changes directly into Word.
Security & Compliance
Yes. Asthra is designed with enterprise-grade security for regulated life sciences environments. We are SOC 2 Type 1 ready and actively pursuing SOC 2 Type 2, ISO 27001, GDPR, and HIPAA certifications. Data is encrypted in transit (TLS 1.2+) and at rest (AES-256). Role-based access controls and audit logging are built in.
The retrieval layer does not. Asthra uses only the source documents you provide; there is no open-internet retrieval and no training-knowledge leakage. The drafting layer uses Anthropic Claude via the commercial API, where customer data is not used to train models.
Source documents and generated outputs are retained for the duration of your subscription. They are never used to train models — ours or a third party's. Deletion requests are honoured within thirty (30) days of written request. Tighter SLAs can be agreed in the master services agreement. Transaction ledger entries required for regulatory traceability may be retained longer, per your validation posture.
Yes. Asthra is available as managed SaaS. For customers with specific data residency or security requirements, we also support deployment in customer-managed private cloud environments or dedicated VPCs (AWS, Azure, GCP).
Integration & Getting Started
Yes. Asthra integrates with Document Management Systems to enable source document selection directly from your DMS. This streamlines workflows and ensures documents are retrieved from your system of record.
Asthra supports standard ICH E3 CSR templates, TransCelerate CSR templates, ICH-based PSUR/PBRER templates, eCTD Module 3 templates, and customer-specific custom templates. Templates are onboarded and configured by the Asthra team.
The Asthra team handles full template configuration, including prompt design, testing, and validation to ensure the system generates output aligned with your standards. Timelines depend on template complexity and customization needs. We work with you to create a pilot-ready setup.
Contact us to request a demo. We'll discuss your document types, review your templates and workflows, and set up a pilot to show you how Asthra can accelerate your specific documentation process. From there, we can plan full implementation.
Have more questions?
Get in touch. We're happy to discuss how Asthra fits into your documentation workflow, your validation posture, and your security review.
Get in touchLast updated: 16 April 2026