Episode Details

In this QCast episode, Jullia and Tom demystify data validation in clinical data management — how a lean, risk-based approach safeguards data integrity and supports confident database lock, inspection readiness, and downstream SDTM and ADaM deliverables. 

Key Takeaways

• Prioritise a lean Data Validation Plan that targets critical data, tunes top checks, controls changes and captures test evidence.
• Treat third-party data as first-class by standardising units and timestamps, validating imports and reconciling on a steady cadence.
• Connect monitoring and validation with shared dashboards, agreed thresholds and coordinated actions to focus effort and cut noise.
• Prove and improve by tracking balanced metrics, holding post-lock retrospectives and promoting proven rules into a reusable library. 

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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.