Structured Content AI for Clinical Labeling

Is your clinical label generation timeline holding your team back? Stay ahead of your competition with ComplianceAuthor® AI.
HOW IT WORKS

Add generative AI to your
clinical labeling workflow

ComplianceAuthor® AI simplifies your internal processes around authoring, reusing, translating, and managing clinical labels.

ComplianceAuthor® AI uses natural language processing specifically designed for pharmaceutical companies to index your existing clinical information into one controlled system.

ComplianceAuthor® AI allows easy management of your phrase libraries in an intuitive user interface. With preconfigured business rules study labels can be automatically assembled based on country regulations.

ComplianceAuthor® AI helps users, health authorities and authorized third parties easily collaborate. Harmonize internal and external comments, edits, and tracked changes automatically in one document.

ComplianceAuthor® AI manages technical translations out of the box. ComplianceAuthor AI supports both in-house and third-party translation service providers.

ComplianceAuthor® AI leverages approved phrase libraries, translations, and study labels to automatically generate clinical labels for different markets, improving your go to market timing

KEY BENEFITS

Precision and compliance
for clinical labeling

Clinical labeling isn’t just about putting words on a label; it’s about accurately conveying vital information. ComplianceAuthor AI® combines scientific rigor with meticulous attention to detail to ensure that every clinical label is true and compliant representation of your product.

Supports a diverse end-to-end ecosystem

Streamlined label authoring

Effortlessly accelerate label creation, review, and translation, reducing time-to-market and boosting productivity.

  • Rule-based label generation to meet regulatory requirements
  • Reduced workload and rework costs
  • Reduced label creation from weeks to days.

Quality and compliance for clinical trials

Enhance operational compliance and data integrity by replacing error-prone manual processes.

  • Alignment to national and global regulatory standards
  • Validated regulatory and business rules engine for enforced compliance
  • Automation for end-to-end regulated content management
Passed internal QA review
Natural Language Technology

Works with your tech stack

ComplianceAuthor AI® easily integrates with clinical supply chain systems for rapid access to data.

  • Supports randomization, label design, and proof printing
  • Enables translation and ERP integration
  • Maximizes the value of your data supply chain
USE CASES

Designed for clinical label content

Discover a faster way to author, collaborate on, and manage clinical label content, allowing your team to eliminate wasteful rework and dramatically reduce manual processes.

Content analytics and dashboards

Access your in-progress and completed clinical labels with associated KPIs.

Automated document assembly

Select a preconfigured set of properties to automatically create labels with required phrases for each study.

Configurable rules engine

Capture your regulatory requirements in a rules engine to generate accurate, complete, and compliant labels.

What users say about ComplianceAuthor® AI

Quotes

What users say about ComplianceAuthor® AI

Working with Glemser as our clinical labeling provider for over a decade, we have reduced our clinical labeling timelines from 4 weeks to just 4 days. Their expertise and solutions have been essential in streamlining our process.

Director, Global Packaging Management, Large UK Pharma
TOP FEATURES

Tools for clinical labeling teams

Streamline the way your team creates and collaborates on clinical label components with AI-powered features, advanced tools, and familiar integrations that help you work faster and maintain compliance.

Life sciences extensions (CFR Part 11, e-Signatures & more)
unstructured to structured data conversion
Familiar Microsoft Word interface
Automatic XML generation
configurable rules engine
approved phase libraries with translations
Collaborative review process
Automatic feedback merging
CLOUD-BASED COMPONENT CONTENT MANAGEMENT SYSTEM
integrates with external translation services
Integrates with other solutions (Veeva, Documentum, Sharepoint)
Pre-configured outputs & picklists

See what your clinical labels look 
like in ComplianceAuthor AI®