The annual U.S. conference hosted by the Society for Clinical Data Management (SCDM) is a premier gathering of clinical data professionals, offering sessions on data standards, emerging technologies, regulatory insights, and best practices in trial data operations. CRIO will be in Raleigh for the show, let’s connect to discuss how our eSource and unified workflows support high-quality, efficient data management.
Please join us at the following speaking sessions featuring CRIO’s team!
Date & Time: Tuesday, September 15 at 11:30AM
Speaker: Jonathan Andrus, Co-CEO
Session: Insights from the Authors: Mastering Clinical Data Management. The Background, Experience, and Soft Skills Needed to Succeed in CDM
Details: TBD
Date & Time: Tuesday, September 15 at 4:15PM
Speaker: Jonathan Andrus, Co-CEO
Session: Pulse Check: AI in eSource Six Months Later: What Held, What Shifted, What’s Next
Details: The SCDM eSource Implementation Consortium has spent the past year doing the work. In 2025 and into 2026, the Consortium brought together sponsors, vendors, sites, and industry stakeholders for face-to-face meetings, cross-stakeholder conversations, and a podcast series recorded in early 2026 that took an honest look at how AI is being used across eSource workflows. The Consortium is also on track to deliver an ROI-focused publication this year. Looking ahead, the Consortium is building on emerging conversations with Digital Health Technology.
This panel brings together voices from across the eSource ecosystem to revisit what we heard in those conversations and ask the harder follow-up questions: what has actually changed? Where did early optimism hold up, and where did reality push back? Which challenges got solved, which got worse, and which ones nobody saw coming? Attendees will leave with a clearer picture of where AI in eSource stands today, what questions still do not have answers, and what the Clinical Data Scientist needs to be ready for next.
Date & Time: Wednesday, September 16 at 9:15AM
Speaker: Marc Wartenberger, VP of Compliance and Security
Session: Regulatory Town Hall
Date & Time: Wednesday, September 16 at 11:15AM
Speaker: Marc Wartenberger, VP of Compliance and Security
Session: From Guidance to Practice: How ICH E6(R3) Has Transformed Clinical Data Management Since Its 2025 Adoption
Details: With ICH E6(R3) becoming effective on 23 July 2025, stakeholders in clinical research were tasked with operationalizing a fundamentally revised quality and risk management framework. This shift redefines how clinical data managers approach planning, execution, oversight, and documentation of clinical trials, elevating data quality from a downstream checkpoint to a core driver of trial integrity.
Date & Time: Wednesday, September 16 at TBD
Speaker: Marc Wartenberger, VP of Compliance and Security
Session: Staying Validated in Constant Change: Strategies for SaaS and AI-Driven Clinical Platforms
Details: Sponsors and CROs increasingly rely on a broad range of vendor technologies, from large enterprise platforms to niche solutions that evolve rapidly through Software as a Service (SaaS) release cycles. Traditional, resource intensive validation approaches struggle to keep pace. A risk based, evidence driven approach is needed to support compliant GxP use, including alignment with 21 CFR Part 11 and Annex 11, while reducing operational burden.
In this session, we will explore with the panelists and the audience their strategies for keeping up with frequent vendor software releases and maintaining vendor systems in a validated state. Even more importantly, how will their validation approach change with the introduction of AI-enabled features particularly when full transparency of the underlying algorithm and training data is not known to the customer or end-user?
