Episode 5: CDISC Standards in Clinical Research

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 TakeawaysCDISC 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.🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode.About QuanticateFounded 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.