Episode Details

In this QCast episode, Jullia and Tom unpack real-world evidence in modern drug development — what distinguishes real-world data from the evidence it enables, and how to apply it alongside randomised trials.

Key Takeaways

• Start with the decision, emulate the target trial, and justify methods with clear diagnostics.
• Make data fitness and governance non-negotiable: provenance, completeness, traceability, privacy, and compliant linkage.
• Use RWE to complement trials; for external controls, ensure clinical comparability and robust confounding control.
• Build reproducible capability: curated common data models, versioned code, audit trails, and checks for biases like time zero and overlap.

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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.