QCast: Data-Driven Dialogue in Drug Development
QCast by Quanticate is the podcast for biotech, pharma, and life science leaders looking to deepen their understanding of biometrics and modern drug development. Join co-hosts Tom and Jullia as they explore methodologies, case studies, regulatory shifts, and industry trends shaping the future of clinical research. Where biometric expertise meets data-driven dialogue, QCast delivers practical insights and thought leadership to inform your next breakthrough.
QCast: Data-Driven Dialogue in Drug Development
Episode 16: Statistical Analysis Plans (SAPs)
In this QCast episode, Jullia and Tom unpack Statistical Analysis Plans (SAPs) — the blueprints that define how clinical trial data are turned into evidence. They explore what a SAP includes, how it links to the protocol and estimand framework, and the controls that keep analyses credible, reproducible, and inspection-ready.
Key Takeaways
- Treat the SAP as the bridge between protocol intent and statistical execution.
- Anchor all analyses to the estimand framework to maintain alignment and interpretability.
- Finalise and version-control the SAP before data lock to prevent bias and audit issues.
- Define derivations, flags, and datasets explicitly to enable traceable, reproducible code.
- Keep interim analysis logic clear, with independent oversight and documented firewalls.
- Apply disciplined change control and independent quality checks throughout analysis.
- Make every method explainable to clinicians — clarity, not complexity, drives confidence.
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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.