AI can build your EDC, but it can’t shape your culture

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management.

Imagine a future where uploading a study protocol in PDF instantly produces a database that’s 90% complete. This is no longer science fiction – AI is rapidly bringing this level of automation to clinical data management. But before we celebrate, we must ask: are our processes and teams ready to handle it?

This presentation explores the intersection of AI innovation and operational readiness within data management. Using real-world examples such as AI-driven protocol-to-EDCbuilds and automated data insight generation, we’ll examine how organizations can unintentionally undermine the benefits of AI by neglecting process design and cultural adaptation.

This session brings together three complementary perspectives:

• Kelly Forester, a data management expert with over 30 years of experience navigating multiple waves of technological change.
• Sylvain Berthelot, a technology-vendor specialist with more than 20 years of seeing sponsors and CROs struggle when tools are adopted before processes and culture are ready.
• Emmanuelle Hoarau, a domain intelligence leader with deep expertise across life sciences, biotechnology and medical devices, helping organisations align scientific talent strategies with emerging industry trends.

Together, they offer a clear, practical view of how to implement innovation in ways that truly work.

Attendees will gain practical perspectives on how to evaluate whether AI is the right tool for a given challenge, how to redesign workflows to integrate automation effectively, and how to foster a culture that embraces change and collaboration. Because in the age of AI, success isn’t defined by how intelligent the technology is – but by how intelligently we prepare our people and processes to use it.

MEET THE SPEAKERS

Kelly Forester: I serve as the Sr Director of Data Management Solutions and Services at Vita Global Sciences, bringing nearly three decades of dedicated experience in clinical research—most of that time focused on the intricacies and impact of Data Management. Throughout my career, I’ve championed innovation, precision, and the highest standards of data quality to help shape meaningful advancements across the life sciences industry. One of the true cornerstones of my professional journey has been mentorship. I’m deeply committed to developing future leaders in clinical research, and I take pride in cultivating inclusive, high-performing teams that are equipped to tackle the challenges of tomorrow. Helping others grow isn’t just part of my job—it’s part of my purpose. I’ve consistently led the development of scalable data strategies and aligned operational frameworks with clinical objectives to drive measurable outcomes. Whether collaborating across functions or steering complex projects, I strive to create environments where insights thrive and therapeutic breakthroughs become reality.

Sylvain Berthelot: Sylvain has dedicated his 21-year long career to providing software for the pharmaceutical industry. He specialized in clinical trials 16 years ago, working at various eClinical technology vendors. His path has taken him on many conference stages, where he consistently strives to make the audience think differently about the topic of focus. Sylvain is passionate about implementing solutions that increase the efficiency of all involved in a clinical trial. He is now the Vice President of Strategy and Marketing at CRScube, where he embraces the company’s goal to make clinical trials accessible to everyone. He also dedicates a lot of his time to patient advocacy, increasing awareness about health conditions through his podcast On One Condition. 

Emmanuelle Hoarau: With a PhD and deep domain expertise, Emmanuelle Hoarau serves as Domain Intelligence Director, based in the Paris region. In this leadership role, she oversees market insights and strategic talent intelligence across life sciences, bridging science, engineering, and medical device sectors to deliver impactful hiring and workforce solutions. She leads a team focused on identifying industry trends and connecting top scientific talent with organizations at the forefront of biotech, pharmaceuticals, and biomanufacturing. Her data-driven approach helps clients build teams aligned with current and emerging needs in research and operations. A recognized thought leader, Emmanuelle frequently shares insights on drug discovery, biomanufacturing, and medical devices through LinkedIn and webinars, with a focus on topics like AI in drug development and life sciences talent trends. She has built a strong professional following, known for her expertise and engagement in domain intelligence. Emmanuelle’s leadership combines analytical rigor, industry insight, and a passion for advancing scientific excellence within her clients’ organizations.