The Quality Issue – February 2025
Reflecting on Two Great Conferences – Let’s Talk!
In this edition of the Quality Issue, we’re taking a moment to look back on two fantastic conferences we’ve recently attended. Too often, we move from one event to the next without stopping to reflect—so we’re changing that!
Take five, grab a coffee (or your beverage of choice), and dive into our key takeaways. And, of course, we’d love to hear yours! Do you agree, disagree, or wish you’d been there?
Enjoy the read!
Reflecting on the 5th RBQM Summit: Collaboration, Insights, and the Future of Clinical Research
“I recently had the pleasure of participating in the 5th RBQM Summit in Philadelphia. While a more intimate gathering, the event fostered an engaging and collaborative atmosphere, bringing together industry experts to share insights, challenges, and innovations in Risk-Based Quality Management (RBQM).
With over 50 attendees, the summit featured a mix of presentations and “fire-side” discussions, highlighting RBQM’s crucial role in the evolution of clinical trials. Expertly moderated by Stephanie Clark of Johnson & Johnson, the agenda covered timely and thought-provoking topics, including:
✅ The Impact of AI and Machine Learning on Clinical Research
✅ Challenges in RBQM Implementation for Large and Small Pharmaceutical Companies
One of the most compelling aspects of the event was the high level of audience participation. The depth and variety of questions raised underscored just how engaged and invested the industry is in advancing RBQM practices.
To round off a productive summit, we shared an informal dinner, where industry leaders continued conversations in a relaxed setting. These moments of connection reaffirmed our collective dedication to integrating RBQM not just as a regulatory requirement, but as a fundamental driver of clinical trial success and the development of new medicines.
As RBQM continues to evolve, events like these serve as invaluable opportunities to share experiences, challenge perspectives, and shape the future of clinical research. TRI looks forward to continuing the conversation and driving innovation in RBQM.” – Steve Matheson, Senior Sales Executive
Reflections on #SCOPE2025: RBQM, OPRA, and Meaningful Conversations
“SCOPE 2025 was an incredible experience! From engaging conversations to insightful presentations, it was a fantastic opportunity to connect with clients face-to-face and discuss how TRI’s OPRA platform is making a real impact in clinical trials.
One of the highlights for me was seeing how the rest of the team approached RBQM discussions—emphasizing its benefits and positioning TRI as a true industry leader. It was inspiring to hear Duncan Hall, CEO, present on How RBQM Is Core to the Evolving Needs of Clinical Research. The session was packed, and it was great to see attendees actively engaging with our approach to RBQM. (*see below for another opportunity to join this presentation)
RBQM Is Gaining Momentum
A key takeaway from SCOPE was the growing recognition of RBQM’s importance across the industry. Many sponsors and CROs shared that they’ve been handling Risk Assessments in-house but are now seriously considering external RBQM vendors like TRI. The shift in mindset was clear—RBQM is no longer a “nice to have” but a critical component of trial success. One standout moment was seeing a CRO we spoke to earlier in the event attend Duncan’s session and ask in-depth questions about our RBQM approach. It reinforced just how relevant and timely our solutions are.
Beyond the Conference: A Balanced Experience
Despite the packed schedule, I still managed to squeeze in the 5K run and hit the gym, making SCOPE the perfect blend of learning, networking, and staying active. Events like these are not just about business—they’re about connecting with like-minded professionals, sharing ideas, and enjoying the experience.
As the industry continues to evolve, it’s clear that RBQM is gaining the attention it deserves. We’re excited to keep the conversation going and help more organizations streamline their RBQM processes with OPRA.” – Lamek Ogwal, Business Development Specialist
Key Takeaway
Data was a major topic of discussion at SCOPE. But while we’re surrounded by data, the real challenge lies in transforming it into meaningful insights that enable study teams to make timely, actionable decisions. Compared to SCOPE 2024, there seems to be a shift, possibly influenced by the adoption of ICH E6(R3), but more likely due to the growing maturity of RBQM practitioners. Many conversations focused on refining analytics, by making data more accessible and useful, particularly through tools like data visualization that clearly tell the story of a study—what happened, when, and what the impact was. Finally, there’s still work to be done in making the case for RBQM within both Sponsors and CROs. Evidence from ACRO and others highlights that adoption remains a challenge, but bringing data to the table that demonstrates RBQM’s effectiveness has the potential to accelerate not only RBQM itself but also the speed and efficiency of clinical trials
Dates for your diary
Webinar – How RBQM Is Core to the Evolving Needs of Clinical Research
Free Webinar: Thursday 27th February, 10am ET/3pm GMT
Due to its popularity at SCOPE, Duncan Hall has agreed to repeat his presentation as a 30-minute webinar, available to all Sponsors and CROs.
As clinical trials become more complex, the utility of RBQM is increasing, as are the technical demands. The need for experienced CRO support and a strong relationship between Sponsor, CRO, and technology is more important than ever.
Duncan looks at emerging demands on both parties and how great RBQM process and technology is the foundation of trust and performance.
ACDM: Association for Clinical Data Management ACDM25 Prague 2nd-4th March
The Largest Clinical Data Management Conference in Europe
Have you booked your tickets yet? The must-attend event for clinical data management professionals. Following the success of ACDM24, which saw nearly 500 participants from 30+ countries, ACDM25 promises even more exceptional learning and networking opportunities. Featuring world-class speakers, cutting-edge workshops, and vibrant panel discussions, this conference is the ultimate platform to expand your knowledge, share insights, and connect with leaders in clinical data management.
We’ll be there and look forward to catching up with you.
Until next month! 😀