Episode Details

Clinical traceability is about being able to follow evidence from a reported result back to its source and understand the transformations, decisions, and records in between. In this QCast episode, co-hosts Jullia and Tom discuss how traceability can become harder when studies involve multiple systems, CROs, laboratories, and technology providers, and why retaining files alone is not enough.

Key Takeaways

• Strong traceability connects reported results with the underlying data, derivations, programs, and supporting decisions, rather than relying on file retention alone.
• Outsourced studies can increase traceability complexity because data and responsibilities are distributed across several organisations and systems.
• A practical review can work in both directions: start with an important result and trace it back to source, then start with a source variable or external data stream and identify which analyses depend on it.

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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.