Episode Details

In This QCast episode, join co-hosts Jullia and Tom as they unpack CDISC standards in clinical research, exploring the core content models from PRM to SEND, the exchange formats like ODM-XML and Define-XML, and how to streamline your trials with faster regulatory approvals, lower costs, and analytics-ready datasets.

Key Takeaways

• CDISC standards are a unified set of content and exchange models for collecting, structuring, and submitting clinical trial data.
• Their core concepts include end-to-end traceability through CDASH, SDTM, and ADaM backed by controlled terminology.
• CDISC outperforms bespoke formats by cutting manual mapping, speeding regulatory review, and ensuring seamless interoperability.
• Successful implementation requires a gap audit, a pilot SDTM/ADaM mapping, validation tools, and team training.
• Common pitfalls include delaying terminology checks, underestimating Define-XML effort, and leaving legacy data unconverted.

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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.