#USA #Princeton #clinical study #Regulatory Writing #ZYLiQ

Introduction

Recently, ZYLiQ, a frontrunner in AI and machine learning solutions for regulatory medical writing, unveiled its newest product, ZYLiQ Version 4.0. This significant update not only enhances automation in the creation of clinical study reports (CSRs) but also expands into new regulatory document modules that are set to revolutionize the regulatory writing landscape.

Key Features of ZYLiQ Version 4.0

ZYLiQ has pioneered the use of Generative AI (GenAI) for regulatory writing, resulting in a remarkable acceleration of CSR development by up to 75%. The company's latest offerings include a range of features aimed at improving the efficiency and efficacy of regulatory documentation.

Enhanced CSR Automation

Some of the notable enhancements include:

• - Automatic Source-Type Prediction: This feature enables the platform to intelligently predict the type of sources used in user-added sections, streamlining the writing process.
• - Optimized Synopsis Creation: Users can benefit from GenAI-powered content that fine-tunes synopsis sections, allowing for quicker assembly of essential report summaries.
• - Tense Conversion and Lean Writing: The tool now supports automatic tense conversions, promoting consistency and clarity in documentation.
• - AI-Assisted Conclusion Drafting: ZYLiQ facilitates the drafting of Safety and Efficacy conclusion sections, allowing authors to focus on higher-level insights rather than getting bogged down in details.

New Regulatory Modules

In addition to CSR enhancements, Version 4.0 introduces multiple new modules designed to tackle a variety of regulatory documents:

• - Safety Narratives: Automatically extracts necessary data from listings, SDTM/ADaM datasets, and patient profiles to rapidly create safety narratives. Users have reported a staggering 90% reduction in completion time.
• - Informed Consent Form (ICF) Generation: This module takes protocol and investigator brochure information to guide writers through the automated creation of ICFs, incorporating templates specific to the sponsor's guidelines.
• - Plain Language Summaries: The platform has added capabilities for generating Plain Language Summaries for both CSRs and protocol documents, making complex information more accessible for lay audiences.
• - Redaction and Anonymization: Automatically masks or anonymizes any sensitive information found within documents, addressing one of the industry's pressing compliance needs.

Implications for the Industry

The launch of ZYLiQ Version 4.0 underscores the company's commitment to addressing regulatory writing challenges head-on. The continued focus on automating specific tasks has resulted in a highly refined solution that promises to save time and reduce risks associated with human error in documentation.

ZYLiQ's dedication to providing practical solutions tailored for regulatory writing challenges positions the company as a crucial player within the industry. The high renewal rate from existing customers reinforces the platform's efficacy and reliability.

Pilot Program

To further demonstrate the effectiveness of Version 4.0, ZYLiQ offers prospective clients a two-week pilot program. This allows potential customers to compare their current legacy processes with the accelerated automation capabilities of ZYLiQ, highlighting the efficiency and ease of use that the platform promises.

Conclusion

ZYLiQ continues to lead the charge in transforming the landscape of regulatory writing through innovative use of AI technologies. With the introduction of Version 4.0, regulatory professionals can expect enhanced automation capabilities, streamlined processes, and significant time savings. As the demand for efficient regulatory writing solutions grows, ZYLiQ's advancements solidify its position at the forefront of the industry.

For more information and to book a demo, visit ZYLiQ's website or contact their team directly at +1 949-878-2121.