Faster statistical documentation designed to support your team
We combine deep biometrics expertise with cutting-edge artificial intelligence to streamline the production of clinical documents.
Quanticate has developed sophisticated AI-driven tools designed to streamline and enhance the production of critical clinical research documentation, particularly Statistical Analysis Plans (SAPs), Clinical Study Reports (CSRs), and datasets aligned with the CDISC Analysis Results Standard (ARS). Leveraging advanced Natural Language Processing (NLP), Retrieval-Augmented Generation (RAG), and structured knowledge representation techniques, these AI tools significantly reduce manual effort while ensuring high-quality, consistent, and regulatory-compliant outputs.
Our AI CRO Solutions
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Automated Synthesis of SAPs
Our AI synthesis technology parses structured protocol content and associated metadata to generate draft Phase I SAPs. Outputs are aligned with client-specific templates and include section-specific content, and statistical methods descriptions.
By embedding this structured metadata, Quanticate's Python-based systems dynamically assemble SAP sections that are accurate, consistent, and fully traceable to protocol specifications. Drafts are reviewed and finalised by experienced biostatisticians.
Table Output Conversions
Quanticate has implemented cutting-edge methodologies using CDISC's Analysis Results Standard (ARS) to produce structured datasets from statistical outputs. Leveraging tailored Pydantic data models and the OpenAI API with precise response formatting, Quanticate efficiently transforms traditional statistical tables into structured JSON datasets aligned with ARS metadata requirements. This enables automated CSR Results generation, regulatory traceability, and scalability for submissions.
This AI-driven conversion populates ARS-compliant fields within the final output, including parameter identifiers, analysis populations, display titles, statistical methods, and traceability links. As with all of our AI tools, the final draft is quality checked by a member of Quanticate’s statistical team. We also offer scalability for ISS and ISEs and high-volume submissions.
AI-Assisted Generation of CSRs
Quanticate’s advanced Python-based pipelines are powered by Azure OpenAI to automate CSR creation. Through innovative applications of the CORE Reference guidelines, Quanticate's AI tools systematically parse clinical trial protocols, SAPs, and statistical analysis outputs (such as RTF tables) to extract data which then populates sophisticated Pydantic models.
These models encapsulate metadata, summary statistics, and narrative content. This structured approach ensures consistency, regulatory compliance, and accuracy in generated CSR sections, substantially improving turnaround times while maintaining rigorous scientific standards.
Ready to Accelerate Your Reporting with AI?
Through these strategic investments in AI-driven capabilities, Quanticate positions itself at the forefront of biometrics automation, providing sponsors with faster, more reliable, and fully auditable documentation and analytical deliverables.
