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Audit Trails, AI, and the Human Heartbeat

Headshot of Kristine Smith
Kristine Smith
Erin Karlson
October 16, 2025

Key Takeaways from SCDM 2025

The 2025 Society for Clinical Data Management (SCDM) Conference was more than just a gathering—it was a glimpse into the future of clinical trials. The event brought together professionals from across data management to explore innovations, share insights, and discuss the role of technology. At SCDM, professionals found themselves among peers who “get it,” creating a sense of community and shared purpose.

From artificial intelligence (AI) to audit readiness, the conference was packed with forward-thinking ideas and practical applications.

AI in clinical trials: speed meets oversight

One of the most prominent themes at SCDM 2025 was the integration of AI into clinical data management. Attendees discussed how AI is transforming the way databases are built, tested, and deployed.

While traditional database builds can take up to 12 weeks, new platforms promise turnaround times of just a few days. This acceleration could revolutionize timelines for clinical trials.

Throughout the conference, the excitement for speed was tempered with caution. While AI may offer horsepower, it lacks human insights (or heartbeat, as was mentioned during many sessions).

The consensus across data management is clear: automation streamlines processes; human oversight remains essential. Clinical data managers must continue to ensure accuracy, integrity, and ethical standards in every trial.

Audit trail review and inspection readiness

Another major focus was the importance of being inspection ready. Audit trail reviews emerged as a critical component of data management. Experts advocated for dedicated audit trail review plans, emphasizing their role in Good Clinical Practice (GCP) compliance. Moving away from 100% source data verification (SDV) and toward targeted data review plans was highlighted as a necessary evolution.

A well-attended presentation from the US Food and Drug Administration (FDA) emphasized proactive planning and, above all, the need to prioritize patient safety. Mistakes will happen, but collaboration and transparency are key for everyone in the industry. The agency’s message was reassuring and helped us to see an agency with a heartbeat.

Exploring EDC systems and streamlining processes

Attendees also explored alternative electronic data capture (EDC) systems, Discussions included platforms and out-of-the-box solutions that offer integrated reconciliation and faster builds. These systems could be especially beneficial for smaller Phase I and II trials.

The challenge remains in balancing innovation with existing investments. Many organizations have certified programmers trained in specific platforms, making transitions costly. Still, the potential to build multiple databases simultaneously with fewer resources is an enticing prospect.

Challenges and opportunities

The SCDM conference sparked conversations about the future of clinical trials and the next generation of professionals entering the field. As technology continues to evolve, so must training and onboarding processes.

A question has emerged about how do we ensure new talent understands the foundational principles while embracing cutting-edge tools?

SCDM 2025 also reminded attendees of how far the industry has come—from paper-based case report forms to remote data capture to mobile apps. The pace of change is accelerating, and the next five years promise even more transformation.

SCDM: A community of innovators

Beyond the sessions and demos, the conference offered a sense of belonging. Attendees connected with peers from pharmaceutical companies, CROs, and tech vendors, all under one roof. The energy was palpable, with kickoff events resembling concerts and ballrooms filled to capacity.

For many, the experience was both inspiring and validating. SCDM 2025 wasn’t just about technology—it was about people, passion, and data management progress.

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