In this QCast episode, Jullia and Tom explain how AI and automation make clinical data work smoother from smarter screening and electronic consent to streaming device data, auto-summarising notes, targeted monitoring, and faster reports. They outline the basics for linking core trial systems, clarify what regulators expect on validation and audit trails, and share a simple first-year plan with quick wins and common traps to avoid.

Key Takeaways

• Start small with a high-value workflow, define success measures, and scale proven patterns.
• Automation standardises execution; AI prioritises attention—together they surface issues earlier and speed decisions.
• Interoperability and governance matter most: integrate core systems, enforce role-based access, encryption, and complete audit trails.
• Quick wins include NLP-assisted coding and simple RBM rules; benchmark against a baseline to show impact.
• Treat models like regulated components: document purpose and training data, validate performance, monitor over time, and revalidate when processes change.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.