The Quality Issue - August 2025

The Quality Issue: August Edition

Welcome to the August edition of The Quality Issue, your monthly dose of RBQM insights from TRI.

Spotlight: ICH E6(R3) Webinar. Mark Your Calendar!

We’re thrilled to invite you to TRI’s upcoming webinar, ICH E6(R3) and RBQM: What You Need to Know to Drive Trial Success. Join us on 10th September as Duncan Hall hosts a dynamic session on ICH E6(R3) and its impact on RBQM, alongside our exceptional line-up of thought leaders:

Judyth Zahora, PMP – Tyra Biosciences

Rohit Gupta – Indero

Gerard Barron – Clinical Research Consultant

They’ll share insights and real-world experiences, helping you navigate the new guidance with confidence.

Register now – This is one you won’t want to miss!

Industry Insight: RBQM Adoption Surges – ACRO 2025 Report Highlights

The ACRO 2025 RBQM Landscape Report reveals a dramatic shift in how clinical trials are being managed, with 96% of trials in 2024 incorporating at least one RBQM or RBM component, up from just 53% in 2019.

Article content — Phasing Out Traditional Clinical Trials

Key Highlights:

Centralized Monitoring is Now the Norm: Adoption surged post-pandemic and remains high, with 86% of ongoing trials using centralized monitoring in 2024.

SDV and SDR Still Overused: Despite progress, many trials still rely on 100% source data verification (SDV) and source data review (SDR), especially in large studies—costing time and resources with limited benefit.

Sponsor Size Matters: Mid-size sponsors lead in RBQM adoption, particularly in reducing SDR and implementing centralized monitoring.

AI and Data Complexity Are Driving Change: With over 70% of clinical data now coming from non-EDC sources (e.g., wearables, lab data), traditional monitoring methods are no longer sustainable. AI is expected to play a growing role in RBQM strategies.

Regulatory Support is Strong: Both the FDA and EMA continue to advocate for risk-proportional approaches, encouraging sponsors to move away from legacy models.

🔗 Read the full ACRO report here

Heading to Veeva R&D Summit? Let’s Meet!

If you’re attending the Veeva R&D Summit this autumn, we’d love to connect! Whether you’re exploring RBQM for the first time or refining your strategy for ICH E6(R3), this is a great opportunity to get practical insights and inspiration.

Visit the TRI booth to:

Get hands-on with our RBQM platform
Chat with our team about your challenges and goals
Discover how others are navigating the E6(R3) transition

Let’s talk about what matters to you, and how TRI can help.

Meet the team in Boston

All Our Blogs, One Place

As well as our monthly round up, we regularly release new blogs, sharing industry insights and expert opinions, on our website. You can catch up on all our latest blogs here: https://www.tritrials.com/category/news/

See you in September.
The TRI Team 😊