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The OpTImize Summit bringing together professionals across the clinical research industry. This exclusive gathering offers an unique opportunity to network with peers, gain insights from thought leaders, and explore the latest trends and advancements in eClinical solutions. Viewers will benefit from intensive TMF sessions, strategies to maximize technology platforms, updates on real-time compliance, and discussions on innovation in clinical operations.
Explore our collection of past sessions in the videos below.
Elevate your eClinical expertise and drive innovation. Sign up for updates on next year's event now!
Grow your network, connect with colleagues, and share experiences with other clinical professionals
Learn from peers and power users the ways to OpTImize your clinical operations work streams
Learn how to stay inspection ready from real inspection "war stories"
Explore innovative TI use cases with peers who use the platform in novel ways
Take away implementation and everyday best practices from sponsors using TI to pass inspections
BONUS: Enjoy a world-class TransPerfect event experience
When sponsors rely on CROs to manage critical TMF activities, effective oversight and organizational alignment are essential. In this session, CRO leaders will share their perspectives on
TMF management—highlighting strategies to meet sponsor expectations, maintain inspection readiness, and adapt to evolving regulatory requirements.
Study reconstruction is often seen as a last-resort effort, but it’s a vital part of ensuring GCP compliance and inspection readiness. This session will clarify what study reconstruction truly involves and how it can be approached strategically. Experts from Trial Interactive’s TMF Services team will walk through each component, including how to identify missing or non-compliant documentation, issue GCP corrections, log quality issues appropriately and align with audit expectations.
Take the difficulty out of migrations with careful planning, technical expertise and a clear understanding of regulatory expectations. This session will focus on the technical aspects of TMF migration, including metadata mapping, document integrity checks, system compatibility and audit trail preservation.
Gain firsthand insights from site representatives as they discuss strategies for overcoming common challenges in study start-up, ongoing trial management and study close-out. Learn how sites navigate regulatory hurdles, streamline workflows and enhance collaboration to drive trial success.
Artificial intelligence is fundamentally changing TMF management, introducing powerful tools for quality assurance, oversight and cotrialmpliance. This panel will dive into AI-powered TMF automation and how it transforms TMF processes. Learn how organizations are leveraging AI tools like Trial Interactive Automate to identify risks, streamline document classification and enhance real-time insights, ultimately driving greater efficiency and regulatory readiness
Generative AI is transforming the commercial landscape for life sciences organizations, enhancing everything from medical writing to multilingual content creation. This session will showcase real-world applications of AI across key functions, including medical communications, e-learning, digital content, product support and pharmacovigilance. Through data-driven examples, we’ll demonstrate how AI is accelerating timelines, reducing costs and improving engagement—such as a 50% reduction in scientific publication QA time and a 45% increase in training engagement. Whether you’re developing global campaigns or managing complex product information, discover how AI is delivering measurable value across the life sciences space—and what steps your organization can take next.
Achieving TMF excellence requires seamless collaboration across teams like Clinical, Regulatory, Data Management and Quality. In this panel, industry experts will share insights on breaking down silos, fostering communication, and aligning cross-functional priorities to ensure TMF completeness, compliance, and inspection readiness. Learn practical strategies for improving teamwork, streamlining documentation processes, and leveraging technology to create a truly collaborative TMF environment.
in this keynote session, Laurel-Ann Schrader will explore how sponsors can leverage the eTMF as a strategic tool for oversight, inspection readiness and compliance. She’ll outline regulatory expectations from global agencies, including the MHRA, EMA and FDA. Drawing on her real-world experience leading the Trial Interactive client solutions team—where she supports inspection readiness and audit preparedness—Laurel-Ann will highlight how proactive eTMF management can help sponsors mitigate risk.