ZYLiQ Launches Regulatory Writing Automation v4.0 with New Modules

ZYLiQ, a leader in AI/ML-driven solutions for Regulatory Medical Writing, today announced the release of ZYLiQ Version 4.0, further advancing automation and efficiency in clinical study reporting (CSR) and expanding into new regulatory document modules.

As the recognized industry pioneer in GenAI for regulatory writing, ZYLiQ accelerates CSR development by 75%. The strong rate of customer renewals highlights both the innovation and effectiveness of ZYLiQ’s platform in addressing regulatory writing challenges.

Version 4.0 introduces a suite of enhancements for CSR automation, including:

• Automatic source-type prediction for user-added sections
  
• Optimized synopsis content creation
  
• GenAI-powered tense conversion, lean writing and in-text summary generation
  
• AI-assisted drafting of Safety & Efficacy conclusion sections

In addition, new modules debut in ZYLiQ 4.0 for other regulatory documents using GenAI:

• Safety Narratives – Automatically extracts data from listings, SDTM/ADaM datasets, Patient profiles to rapidly generate safety narratives, with customers reporting a 90% reduction in time to completion.
  
• ICF Generation – Ingests protocol and investigator brochure content to guide writers through automated Informed Consent Form (ICF) creation, incorporating sponsor-specific templates.
  
• PLS – Generates Plain Language Summary using CSR as an input automatically in layman language. 
  
• PLPS – Generates Protocol Plain Language Summary automatically in layman language. 
  
• Redaction & Anonymization – Mask or anonymize any sensitive information in any documents.

To validate its claims, ZYLiQ offers prospective customers a free two-week pilot, enabling side-by-side comparisons of legacy processes versus ZYLiQ’s accelerated automation.

“Our focus on regulatory document automation—rather than diluting efforts across many document types—has allowed us to build an exceptionally effective solution,” said Farha Feroze, ZYLiQ’s Inventor and Director of Product Management. “With Version 4.0, we are excited to expand beyond CSR and deliver the same level of innovation to other regulatory documents. I am proud of my team’s effort towards adoption of advanced technologies and better use cases.”