KCR at SCDM 2024: Major Takeaways

KCR Data Management

Associate Director, Clinical Data Management Elizabeth Shealy and Head of Data Science & Documentation Services Amy Wilson during SCDM conference

Representatives from KCR’s Data Management team joined hundreds of industry experts in Boston at this year’s Society for Clinical Data Management (SCDM) Annual Conference.

The themes of the conference included the evolution of Clinical Data Managers into Clinical Data Scientists, patient-centricity, AI/ML applications in data science, quality-by-design and risk based clinical data management, and regulatory compliance and inspection readiness. Representative data managers and data scientists from all parts of the industry — biotech, big pharma, technology vendors and CROs — shared their perspective and experience.

It was a unique opportunity to see similarities and differences to others in the industry. Here are the major takeaways from the KCR team:

• AI & ML are coming to DM… sometime…maybe…if the price is right. Do not fear it though, there will always be a need for a“human in the loop.” AI will do the sifting and sorting of the millions of datapoints associated with a clinical trial, but anything requiring a brain requires a human to make the decision.
• Audit Trail Reviews are a regulatory requirement. KCR DM is ahead of the curve as it seems not all our CDM colleagues have implemented these reviews. We took the right approach to start small with a realistic approach given the volume of data in the audit trail. We should not limit our audit trail review to just EDC data though. It should include all modules we are responsible for: EDC, ePROs, CSS, wearables, etc. I expect our Audit Trail Review approach to grow and evolve over time and am excited about the possibility of using Qlik to support this effort.
• Regarding regulatory compliance and inspection readiness, not to jinx us, but I would say this is an area we knock it out of the park. Our close watch on KPIs relevant to study quality / eTMF filing and implementation of DM Oversight reviews ensure we are ready for that “knock on the door” at any time.

We are excited to implement this information into KCR procedures and we are already looking forward to next year. See you next time, Boston!