With the release of ICH E6(R3), clinical trials are entering a new era of expectations around data integrity, quality by design, and risk-based approaches. This session will examine the key changes introduced in R3 and how they’re impacting sponsor responsibilities, technology use, and inspection readiness. Gillian will also provide an update on the development of version 4 of the TMF Reference Model, which is being revised to meet the needs of today’s digital landscape.

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 and maintain a state of audit-readiness every day.

It’s more essential than ever to ensure quality at every stage of today’s clinical trials. This session explores how sponsors and CROs can elevate quality management through real-time quality reviews, CAPA tracking, and integrated training strategies. Learn how centralized oversight, site collaboration, and smart automation can reduce risk, improve inspection readiness, and drive continuous improvement across studies.

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.

Clinical trials generate large volumes of data, tasks, and timelines. Without centralized oversight, studies can quickly veer off track. This session explores how modern CTMS solutions consolidate workflows into a single source of truth. Discover how enhanced visibility and automation can accelerate decision-making, reduce risk, and improve overall trial performance.

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. Attendees will learn best practices for executing a smooth, validated migration that ensures completeness, accuracy, and ongoing compliance with GCP. Whether you’re preparing for a system upgrade, transitioning vendors, or centralizing legacy data, this session will help you do it right—the first time.

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.

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. Learn how proactive TMF oversight and a structured reconstruction process can not only salvage a trial, but also strengthen your organization’s long-term quality management systems.

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. The discussion will explore best practices for collaboration, the importance of clearly defined roles and responsibilities, and how CROs and sponsors can work together to reduce risk and elevate quality.