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 2: Guide to Integrated Summaries of Safety and Effectiveness
In this QCast episode, join Jullia and Tom as they unpack Integrated Summaries of Safety (ISS) and Effectiveness (ISE), breaking down how companies gather data from multiple clinical trials into a single, clear package that regulators need to approve new drugs and devices.
Key Takeaways
- How pooling trial data uncovers rare safety issues and confirms efficacy.
- Best practices for standardising data collection and formats early.
- Strategies for seamless collaboration between statisticians, programmers, and clinicians.
- How regular double-checks and mock panels prevent regulatory hiccups.
- Ways a polished summary accelerates approval and optimises labelling.
🔗 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.