QCast: Data-Driven Dialogue in Drug Development

Quanticate
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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.

单集

  1. Episode 5: CDISC Standards in Clinical Research

    3天前

    Episode 5: CDISC Standards in Clinical Research

    In This QCast episode, join co-hosts Jullia and Tom as they unpack CDISC standards in clinical research, exploring the core content models from PRM to SEND, the exchange formats like ODM-XML and Define-XML, and how to streamline your trials with faster regulatory approvals, lower costs, and analytics-ready datasets. Key Takeaways CDISC standards are a unified set of content and exchange models for collecting, structuring, and submitting clinical trial data.Their core concepts include end-to-end traceability through CDASH, SDTM, and ADaM backed by controlled terminology.CDISC outperforms bespoke formats by cutting manual mapping, speeding regulatory review, and ensuring seamless interoperability.Successful implementation requires a gap audit, a pilot SDTM/ADaM mapping, validation tools, and team training.Common pitfalls include delaying terminology checks, underestimating Define-XML effort, and leaving legacy data unconverted. 🔗 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. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. 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.

    9 分钟
  2. Episode 4: BOIN Design in Clinical Trials

    7月18日

    Episode 4: BOIN Design in Clinical Trials

    In this QCast episode, join co-hosts Jullia and Tom as they unpack the Bayesian Optimal Interval, or BOIN, design for early-phase oncology studies. You'll hear how BOIN blends Bayesian reasoning with simple decision rules, why regulators now call it 'fit for purpose,' and how sponsors are using it to speed up dose-finding while keeping patient safety front and centre. Key Takeaways BOIN design is a model-assisted Bayesian dose-escalation method with pre-defined escalation, de-escalation and safety rules.Core concepts involve setting a target toxicity rate, calculating helper rates at 60% and 140%, deriving decision limits via Bayesian posteriors and including a 95% safety stop.Compared to the 3+3 method, BOIN locates the true MTD more accurately, allows flexible cohort sizes, and runs off a simple printed decision table.Operational essentials include embedding the decision table in your protocol, aligning toxicity assessment windows (or using time-to-event BOIN), training site teams with examples and running light simulations.Common pitfalls are choosing an unrealistic toxicity target, treating BOIN as 'set-and-forget,' and adding extensions without recalculating the decision boundaries. 🔗 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. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. 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.

    11 分钟
  3. Episode 3: Complex Innovative Trial Designs

    7月3日

    Episode 3: Complex Innovative Trial Designs

    In this QCast episode, join Jullia and Tom as they unpack Complex Innovative Trial Designs (CIDs), exploring how adaptive and Bayesian methods – from response-adaptive randomisation to platform protocols – are transforming clinical research by boosting efficiency, personalisation, and speed. Key Takeaways What makes a trial 'complex and innovative': adaptive rules, Bayesian borrowing, and seamless master protocols.Four CID categories: traditional adaptive, biomarker-guided, Bayesian borrowing, and platform vaccine trials.How CIDs deliver faster timelines, smaller sample sizes, and more ethical patient allocation.Essential preparation tips and guidelines for successful implementation.Common pitfalls to avoid, including under-powered designs, data integrity issues, and mismatched external controls. 🔗 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. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. 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.

    11 分钟
  4. Episode 2: Guide to Integrated Summaries of Safety and Effectiveness

    6月17日

    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. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. 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.

    16 分钟
  5. Episode 1: The Use of Wearables in Clinical Trials

    6月2日

    Episode 1: The Use of Wearables in Clinical Trials

    In our premiere QCast episode, we explore how wearables are transforming clinical trials. Join Tom and Jullia as they unpack the roles of smartwatches, biosensor patches, and implantable sensors in real-time data collection and patient-centric study designs. Key Takeaways How decentralised, patient-centric study designs boost engagement.Best practices for integrating and validating wearable data.Strategies to enhance data quality and streamline operations.Where biometric expertise meets data-driven dialogue, QCast explores how wearables can drive more efficient, inclusive research. 🔗 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. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. 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.

    14 分钟
  • 5 集

关于

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.

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