Description

In this QCast episode, Jullia and Tom explore quality tolerance limits in clinical trials, explaining what they are, how they support risk based quality management, and how to define, monitor and govern them so they genuinely protect participant safety and trial integrity rather than becoming a tick box exercise.

Key Takeaways

• Define QTLs from the risk assessment, link them to truly critical to quality parameters.
• Set a small number of clear, study level limits, document rationale and calculation upfront.
• Embed QTLs into routine dashboards and oversight, trigger root cause analysis when breached.
• Build cross functional governance, review trends, update QTLs as the trial and risks evolve.

🔗 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.