Sign up to save your podcasts
Or
Share Episode 5: CDISC Standards in Clinical Research
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
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 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.
🔗 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 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.
View all episodes
By QuanticateIn 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.
🔗 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 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.