TriloDocs - Key Advancements Over the Last 12 Months

Key Advancements Over the Last 12 Months

 

Positioning for Regulatory, Medical Writing, Clinical, Biometrics, and Innovation Teams

Over the past year, TriloDocs has evolved from a specialised CSR engine into a mature, deterministic clinical regulatory-document platform designed for enterprise-scale accuracy, auditability, and writing velocity. These advancements directly support the priorities of Medical Writing, Regulatory Affairs, Clinical Operations, Biometrics/Statistical teams, and Innovation groups evaluating structured automation.

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1) Deterministic Data Processing at Enterprise Scale 

Matrix-based table parsing 

TriloDocs now deterministically processes all clinical tables - including PK, PD, efficacy, safety, labs, KM plots, deviations, dispositions, demographics, medical history, and medications - with line-level fidelity. This eliminates hallucination risk and ensures consistent interpretation across all study arms and phases. 

Flexible rule-based engine 

Medical writers can now adjust critical signal-identification parameters (for example, cut-offs) to align outputs with protocol intent, statistical guidance, or sponsor-specific conventions. 

Automated data mapping 

Before generation, the platform identifies and displays all source tables to be used. Users can confirm or modify the mapping, ensuring full transparency and reducing downstream QC cycles. 

2) Built-In Quality Control and Auditability 

Traffic-light QC system 

Section-by-section signalling with deep-dives into every table allows rapid troubleshooting and early-stage quality control. 

Version history and regeneration 

All generated versions can be viewed or downloaded, ensuring full audit trails and consistent regeneration when tables or analyses change. 

Signal identification 

The symbolic AI engine identifies clinically relevant signals deterministically, mirroring senior medical-writer reasoning while maintaining traceability and reproducibility. 

3) Expanded Coverage Across Real-World Writing Workloads 

Symbolic engine for data-heavy sections 

TriloDocs now handles all sections that typically dominate writing time and QC - especially PK/PD, 

labs and data-heavy narratives that most tools cannot analyse and make comparisons to identify clinical relevant signals.

In-house GenAI medical-writing agents 

For outputs not handled by the matrix parser, TriloDocs applies a guided GenAI layer built with medical writing guidance, incorporating analysis-specific rules to produce controlled narrative suggestions without introducing drift. 

Lay Summary generation 

A purpose-built, compliant AI module produces patient-friendly lay summaries with CSR content with multiple validating layers, ensuring regulator-aligned structure, and enhanced readability. 

4) Improved User Experience and Enterprise Readiness 

New front-end platform 

The interface has been fully modernised for clarity, speed, and multi-team value generation across Medical Writing, Regulatory, Clinical, Innovations and Biometrics. 

Licensing model aligned to enterprise workflows 

Sponsors retain template and data control while allowing external writing partners to work within project boundaries using the same deterministic engine. 

5) Template Flexibility and TransCelerate Alignment 

Use your organisation’s TransCelerate template 

TriloDocs supports direct use of your organisation’s TransCelerate-aligned templates, preserving your established structure, styles, and compliance requirements. The deterministic engine adapts to your preferred format - whether you follow the TransCelerate standard exactly or customise it for internal conventions. The document is generated and downloadable in MS Word Docx format, ensuring seamless integration with your existing workflows and consistent document generation across all studies and vendors. 

6) Upcoming Modules 

• Investigator’s Brochure – Spring 2026 

• Module 2.7.4 (Summary of Clinical Safety) – Summer 2026 

These additions expand TriloDocs into a broader structured-authoring ecosystem for regulatory documentation. 

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Why Global Teams Are Taking a Demo 

Global pharma organisations are prioritising deterministic automation because it delivers measurable value across multiple functions: 

• predictable DBL→CSR timelines 

• reduced QC cycles and fewer late-stage escalations 

• improved inspection readiness and traceability 

• consistent outputs across internal teams and FSPs 

• scalable automation aligned with digital/AI transformation strategies 

TriloDocs integrates symbolic AI, expert-authored rules, and guided GenAI into a single, compliant platform that generates inspection-ready documents in hours. 

A short demonstration provides the most direct way to understand how this architecture can support your organisation’s clinical and regulatory workflows. Please use the "Book a Demo" function on the page and our team will reach out for a personalised demonstartion.