What Asthra is
Asthra AI is a regulatory writing co-pilot integrated with Microsoft Word that helps clinical, safety, and regulatory teams (from both pharma and device manufacturers) generate compliant first drafts from specified source documents, with writer-defined provenance and control, and traceability built-in.
Asthra Workflow
01
One-time configuration of template: Driven by Asthra team
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Customer’s own template is onboarded on to Asthra.
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Asthra team designs, tests, and validates all the prompts for the template with inputs from writers of the customer on provenance (file, and section/table/image for each content output).
02
Writer selects and imports template from Asthra add-in
To start generating the initial draft, writer selects and imports the template from Asthra add-in.
03
Upload or select source documents
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Writer can either create a new library and upload source documents from their local machine OR Select library if Asthra is integrated with a Document Management System.
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Asthra uses a sophisticated pipeline comprising of open source SLMs fine-tuned on pharma datasets to curate assets like sections, tables, and images from source documents.
04
Generate content section-by-section or all at once
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For each prompt, Asthra identifies relevant excerpts (sections, tables or images) from specific sources for each section based on provenance defined by writer.
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Asthra generates nuanced and consistent outputs (text, table or image) that are auto-inserted into the right location of the template.
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If Asthra is not able to respond to a prompt due to lack of information in the source documents, it flags it with an appropriate message. There is no hallucination.
05
Check provenance and traceability
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For every output, Asthra proactively shares the source file and section/table/image from which it retrieved context.
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In addition, writers can check for detailed and granular citations (file name, page number, and snippet of text) for each sentence of output.
06
Human review + QC checks
-
Writers edit directly in Word.
-
Run QC checks (consistency, missing data flags, cross-references) as-is without impact. Asthra will roll out agents for QC soon.
Asthra Workflow
01
One-time configuration of template: Driven by Asthra team
-
Customer’s own template is onboarded on to Asthra
-
Asthra team designs (, tests, and validates) all the prompts for the template with inputs from writers of the customer on provenance (file, and section/table/image for each content output).
02
Writer selects and imports template from Asthra add-in
To start generating the initial draft, writer selects and imports the template from Asthra add-in
03
Upload or select source documents
Writer can either create a new library and upload source documents from their local machine OR Select library if Asthra is integrated with a Document Management System
Asthra uses a sophisticated pipeline comprising of open source SLMs fine-tuned on pharma datasets to curate assets like sections, tables, and images from source documents.
04
Generate content section-by-section or all at once
-
For each prompt, Asthra identifies relevant excerpts (sections, tables or images) from specific sources for each section based on provenance defined by writer.
-
Asthra generates nuanced and consistent outputs (text, table or image) that are auto-inserted into the right location of the template.
-
If Asthra is not able to respond to a prompt due to lack of information in the source documents, it flags it with an appropriate message. There is no hallucination
05
Check provenance and traceability
-
For every output, Asthra proactively shares the source file and section/table/image from which it retrieved context
-
In addition, writers can check for detailed and granular citations (file name, page number, and snippet of text) for each sentence of output.
06
Human review + QC checks
-
Writers edit directly in Word
-
-
Run QC checks (consistency, missing data flags, cross-references) as-is without impact. Asthra will roll out agents for QC soon.
What makes Asthra different
Writers stay in control
Asthra accelerates drafting with writers deciding which section or table or image to be referred to generate each section.
Evidence-backed outputs
Outputs are grounded in the provided source set with traceability through on-demand citations.
No configuration required off writers to generate initial drafts
Asthra intelligently figures out the context for each prompt to generate the initial draft with zero intervention by writer.
Built to handle complex and large PDF source documents
Asthra’s document processing stack has been purpose-built to handle complex PDF source documents with high quality.
Input | Output |
|---|---|
Batch manufacturing records, Certificates of analysis, etc. | CMC initial draft |
Previous PSUR, CDS, Sales data, Safety line-listings etc. | PSUR initial draft |
Trial protocol, TFL, SAP | CSR Initial draft |
Trust and compliance
Data boundaries
Uses only the sources you provide. Does not leverage information from the internet or the LLM’s own knowledge
No hallucination claim
Flags missing info instead of fabricating
Traceability
Citations and evidence review
Validation readiness
SOC2 Type 1: Ready. CSV, SOC2 Type 2, ISO27001, GDPDR, HIPAA: Underway
Trust and compliance
Data boundaries
Uses only the sources you provide. Does not leverage information from the internet or the LLM’s own knowledge.
No hallucination claim
Flags missing info instead of fabricating.
Traceability
Citations and evidence review.
Validation readiness
SOC2 Type 1: Ready.
CSV, SOC2 Type 2, ISO27001, GDPR, HIPAA: Underway.