AgileWriter.ai®

Spending too much time manually preparing submission documents? AgileWriter.ai® is the intelligent digital dossier that unifies every stage of clinical and regulatory documentation workflows into one complaint, Azure-hosted environment for life science companies seeking to apply AI for clinical trials responsibly. It supports end-to-end automation across the entire development lifecycle-from protocols, informed consent forms and clinical study reports to investigator brochures, narratives, annual reports and submission modules.

Traceability & Explainability

Every generated element is traceable to its data source and transformation step, supporting human oversight. Built-in audit trails and validation logs verify the provenance and rationale behind outputs. This explainable-by-design architecture aligns with Azure's responsible AI principles and supports auditable automation for regulatory documentation.

Integration & Scalability

AgileWriter integrates natively with Veeva Vault, Microsoft 365 and Microsoft Entra, enabling seamless collaboration and identity-based access. Its modular design allows scalable deployment within existing tech stacks, adapting easily to diverse sponsor, CRO and biotech environments. Built on Azure OpenAI Services, AgileWriter extends automation beyond authoring into cross-workflow orchestration for regulatory documentation and clinical trail automation.

Key Benefits

Secure and scale with Azure-native infrastructure. Protect sensitive regulatory content with enterprise-grade encryption, Azure Active Directory-based identity management and global scalability across life-science organizations.

• Accelerate documentation timelines by up to 75%. Reduce writing and formatting cycles from weeks to days through one-click automation, redaction, publishing and validation-ready templates.
• Automate every document type end-to-end with up to 90% accuracy. Streamline creation of protocols, ICFs, CSRs, narratives, IBs, DSURs, briefing documents and more-all managed within a single intelligent digital dossier.
• Combine symbolic, machine learning and generative AI. Apply the right AI method-machine learning, symbolic reasoning, NLG or LLM summarization-for each task to ensure precision, explainability and compliance. Regulatory SMEs designed every algorithmic step for accuracy and auditability.
• Maintain full traceability and explainability. Trace every element to its source and rationale with audit trails, version control and logs-supporting transparency, accountability and explainable AI in alignment with 21 CFR Part 11, GxP and EU AI Act principles.

• Collaborate efficiently with human-in-the-loop workflows. Enable real-time review through prompt-based chat and guided workflows that keep experts in control while boosting productivity.
• Ensure compliance by design. Operate in a validation-ready, audit-friendly environment built specifically for regulatory, clinical and nonclinical documentation requirements.

AgileWriter.ai® transforms regulatory writing into an intelligent, collaborative and traceable digital ecosystem, enabling you to move knowledge instead of files. Learn more at https://www.synterex.com/software-solutions/agilewriter-ai or explore case studies showing 94% accuracy and 90% time-savings in ICF generation!

Why Azure

AgileWriter.ai® is optimized for Microsoft Azure’s trusted cloud infrastructure, offering security, scalability, and compliance for regulated industries. AgileWriter leverages Azure AI Services and Azure OpenAI connectors to deliver scalable automation across global life-science organizations. Azure ensures encrypted data residency aligned with HIPAA, GDPR, and 21 CFR Part 11 standards, while Azure Active Directory and Microsoft 365 streamline authentication, automation, and collaboration, making AgileWriter a native fit within the Azure ecosystem.