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No Mistakes, Just Happy Little Requirements: Evaluating the AI Landscape and a Brief Demo of AgileWriter™
Exploring artificial intelligence (AI) in medical writing can feel like stepping into
an uncharted wilderness—full of promise but also potential pitfalls. How do you
navigate this evolving landscape, assess organizational readiness, and ensure
AI solutions align with your needs? This webinar will guide you through key
considerations for understanding your needs, evaluating potential product
features, understanding cybersecurity risks, and making informed decisions
without getting lost in the technical weeds. We will also showcase
AgileWriter™, an AI-enabled document authoring and management platform designed
to streamline workflows while supporting high-quality medical writing. Whether
you're charting your first course into AI or refining your evaluation process,
this session will help you map out a practical approach—because in AI, as in
art, there are no mistakes, just happy little requirements.
Learning Objectives
After participating in this webinar, participants should be
able to
- Identify key factors in assessing the AI technology landscape for medical writing, including external trends, technological capabilities, and organizational considerations.
- Understand the importance of aligning AI evaluation with broader operational strategies, including regulatory compliance, cybersecurity, and data governance.
- Discover how tools like AgileWriter.ai can automate and expedite document creation, ensuring accessibility and regulatory compliance while getting your important information to various audiences.
Target Audience: The target audience will include clinical trial
professionals working in pharmaceutical/biotech industry, especially those with
a focus on medical writing, regulatory, and clinical operations.
About the Presenters:
Jeannette Towles, MA, DASM, RAC-Drugs, is President and owner of Synterex, Inc., a woman-owned, disability-owned clinical and regulatory consulting firm specializing in agile-based project management methodology, automation, and AI-driven technologies. Prior to that, she held in-house consulting and FTE medical writing and clinical science positions at both small- and large-size companies, including managing a group of programmers and vendors working on automated documents, with cumulative industry experience of nearly 20 years. She lives in the Boston area with her husband, 2 children, and dog.
Pallabi De, PhD, is an accomplished medical writing professional with over 15 years of experience in the industry. She has successfully authored and managed a wide range of regulatory documents, leading numerous IND and NDA submissions across diverse therapeutic areas. Pallabi is highly skilled in clinical trial transparency and the disclosure process and has a strong track record of optimizing document management practices. As a leader, she has driven significant process improvements and led high-performing medical writing teams. Currently serving as Senior Director of Medical Writing Technology and Content Architecture at Synterex, Pallabi is leading the integration of advanced technology solutions, including AI-based tools, into medical writing, playing a pivotal role in shaping the future of the field. She is also a member of the American Medical Writers Association (AMWA) AI Task Force.
Jason Casavant, JD, Executive Director of Medical Writing and Quality Assurance at Synterex, is an industry veteran with over 20 years of experience who has led teams within regulatory writing, operations, quality, and training/education. He has a strong interest in promoting quality and process improvement, with a focus on minimizing complexity, strong communication, and training.
Alex Olinger is the Information Technology Manager at Synterex. With a keen interest in endpoint management, Alex specializes in creating seamless user experiences across diverse platforms, ensuring that technology is accessible, intuitive, and efficient. Dedicated to the optimization of daily operations, Alex has a passion for harnessing the power of automation to streamline tasks. Adept at utilizing Application Programming Interfaces (APIs), Alex has developed a reputation for his ability to automate routine tasks, thereby increasing productivity and freeing up resources for strategic projects. Alex's knack for technological innovation coupled with his proactive approach to problem-solving has made him a valuable asset in the IT landscape. He thrives in a challenging environment, constantly pushing boundaries to improve systems and processes for the betterment of the user experience.
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