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Accelerating Authoring and QC of Clinical Documents with AI-Powered Automation
Discover how collaborative workflows are transforming regulatory medical writing by automating document creation and quality control (QC) processes. This session explores the automated authoring and QC of clinical and regulatory documents and its broader impact across pharmaceutical functions. We will demonstrate how GenInvo tools—DocWrightAI™ and DocQC™ leverage AI algorithms to automate the authoring and quality reviews of clinical and regulatory deliverables. Learn how thoughtful AI integration can improve work-life balance and streamline task and deliverable management. Attendees will see examples of advancements in Protocol, Clinical Study Report (CSR), Patient Narratives, and Quality Reviews all accessible via laptop or tablet. The session highlights how blending human expertise with AI can enhance productivity, allowing writers to focus more on scientific depth and quality.
We'll share real-time information showing measurable improvements in accuracy and time savings, offering a clear, data-driven view of how AI is shaping the future of medical writing.
Learning Objectives
After participating in this webinar, participants should be
able to
- Identify the desired balance between automation and human input in clinical and regulatory writing.
- Review real-time statistics on accuracy and time savings, assessing their impact on efficiency.
- Recognize areas for effective AI application, including specific tasks and processes in clinical and regulatory writing.
- Analyze the usefulness of automation in authoring and content review, gaining insights into its potential and limitations.
Target Audience:
Medical writers and regulatory professionals exploring AI to improve workflows and streamline content development and quality checks (QC) in regulatory medical writing. Ideal for regulatory and clinical medical writers, at an intermediate to expert level, focused on innovation and digitalization.
About the Presenters:
Inderjeet Arora is a seasoned Statistician with a Master's in Statistics and over 13 years of experience in clinical research. He has a strong background in biostatistics, clinical data management, and regulatory writing, with expertise in tools like SAS, R, Python, and VBA. He specializes in automating clinical trial processes using AI-driven solutions. Daragh Ryan is a seasoned innovator and leader with over 20 years of experience in clinical research technology. He brings deep expertise across both the technical and strategic dimensions of the biotech and pharmaceutical industries. Driven by a passion for modern technology, Daragh is committed to eliminating inefficiencies throughout the clinical trial process. He is a strong advocate for artificial intelligence as the next-generation solution for advancing clinical research and development.
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