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 7: A Guide to Phase 1 Clinical Trial Designs
In this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutting timelines without sacrificing data quality.
Key Takeaways
- Phase 1 is more than a basic safety check: it establishes pharmacokinetic and tolerability benchmarks that guide every later trial.
- Single ascending-dose studies map how a single dose behaves in the body, while multiple ascending-dose work reveals accumulation and longer-term durability.
- Adaptive escalation designs such as BOIN use real-time probability updates to find the right dose faster and with fewer volunteers.
- Early food-effect and drug to drug interaction trials determine prescribing instructions and label warnings before larger studies begin.
- Integrated protocols such as combining dose stages, meal-effect parts and interaction checks with interim review gates save time, reduce costs, and preserve trial flexibility.
🔗 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.