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GenAI in Action: Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma

This session will present an off-the-shelf generative artificial intelligence (GenAI) powered medical and regulatory authoring platform, proven in global pharmaceutical deployments. This webinar will showcase real-world case studies via the AuroraPrime platform—a trusted Word add-in already implemented by 10 global pharmaceutical companies and several leading contract research organizations (CRO). The platform revolutionizes regulatory and medical writing by:

• Significantly reducing first-draft time for clinical study reports (CSR) and protocols

• Delivering 30–50% overall time savings for CSRs, as validated by two of the world’s top ten pharma companies

Join us for a live demonstration of AuroraPrime’s most impactful GenAI features, designed to enhance compliance, quality, and consistency. Hear how forward-thinking teams are accelerating timelines and adopting best practices in clinical document creation. Attendees will gain actionable strategies, deeper insight into real-world GenAI applications, and proven examples of measurable benefits.

Learning Objectives

Key points to explain and demo include:

• Integrated Authoring Solution:
  Demonstrate a Word plugin designed to seamlessly integrate with existing workflows and
  upstream/downstream systems (e.g., Veeva RIM) to automate document assembly.

• Cross-Document Content Reuse & Standardization:
  Demonstrate a GenAI framework for reusing and standardizing content across multiple
  document types, enabling enterprise-wide, scalable authoring.

• GenAI-Driven Quality Control:
  Explanation of an automated quality control process harnessing GenAI to ensure accuracy,
  consistency, and regulatory compliance.

• Change Management Strategy:
  Practical insights and lessons learned from enterprise deployments, including approaches
  and best practices for effective GenAI adoption, along with measurable outcomes and costeffective
  strategies.

Target Audience: 

• Medical Writers and Regulatory Executives seeking automated, GenAI-driven tools

• Regulatory and Medical Writing Professionals aiming to enhance efficiency

• Digital Innovation, R&D, IT and Clinical Development Leaders integrating GenAI into writing processes
  

Karen J. Devcich, MS, MBA, Vice President, Medical Writing, Quality & Editing and Clinical Trial Transparency, ICON plc

Karen J. Devcich is an accomplished clinical development professional with over 30 years of industry experience across various roles in leading pharmaceutical organizations. She provides strategic and operational oversight for multiple programs spanning all phases of development. With extensive experience in investigational new drugs (INDs), clinical trial applications (CTAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and global submissions, Karen is a recognized expert in Clinical Trial Transparency across multiple therapeutic areas. She has played a pivotal role in developing policies and procedures for implementing Clinical Trial Registries and Disclosures, including Clinical Trial Data Sharing. With over 9 years in Clinical Research Organization (CRO) experience, Karen has worked within both Full Service and Functional Service Provider models. She is deeply motivated by the potential of innovative medicines to improve patients' lives.

Cieayrra Boozer, Product Solution Specialist, AlphaLife Sciences

With over a decade of experience in the life sciences, Cieayrra offers strategic expertise in operations and product consulting. Leveraging deep industry knowledge, Cieayrra helps deliver strategic approaches and solutions to address the needs of the industry and the drug development process.

About the company:

AlphaLife Sciences is a leader in GenAI-driven clinical development, backed by industry leaders such as Johnson & Johnson Innovation JLABS, Veeva’s AI Program, Microsoft’s Pegasus Program, Google for Startups, and Nvidia Inception Program. We’re actively shaping the industry through TransCelerate and CDISC initiatives—accelerating drug R&D and regulatory submissions to deliver life-saving treatments faster.