DiscoverQCast: Data-Driven Dialogue in Drug DevelopmentEpisode 19: Data Validation in Clinical Data Management
Episode 19: Data Validation in Clinical Data Management

Episode 19: Data Validation in Clinical Data Management

Update: 2025-10-31
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Description

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. 


🔗 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.
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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.

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Episode 19: Data Validation in Clinical Data Management

Episode 19: Data Validation in Clinical Data Management

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