Description

In this QCast episode, Jullia and Tom break down the Investigator’s Brochure (IB) and why it remains a cornerstone of safe, consistent trial conduct. They explain what an IB is, who relies on it, and how it complements the protocol by translating the evolving evidence base into practical guidance on dosing rationale, monitoring, and risk management.

Key Takeaways

•  Understand what an Investigator’s Brochure is, who it’s for, and how it supports risk and benefit assessment alongside the protocol.
•  Learn what makes an IB usable in practice, including clear structure, concise summaries, and actionable guidance for investigators.
•  Apply practical safeguards, from keeping IB and protocol aligned to managing RSI, version control, and timely updates when significant new safety information emerges.

🔗 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.