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.

  1. 1d ago

    Episode 64: Tipping Point Analysis in Clinical Trials

    Tipping point analysis helps trial teams understand how strongly a study conclusion depends on assumptions about missing data. In this QCast episode, co-hosts Jullia and Tom discuss how the method relates to MAR and MNAR, how delta adjustments can identify a tipping point, and why the numerical result still needs clinical interpretation. Key Takeaways Tipping point analysis tests how far assumptions about missing outcomes must change before a predefined trial conclusion changes.The tipping point needs to be interpreted in clinical context, including the endpoint scale, reasons for missingness, and number of participants affected.Continuous, binary, and time-to-event endpoints require different approaches, and prespecification helps keep the analysis aligned with the intended clinical question. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 64: Tipping Point Analysis in Clinical Trials

  2. Sep 11

    Episode 63: Audit Trail Review in Clinical Trials

    Audit trail review can involve far more than checking whether a system records changes. In this QCast episode, co-hosts Jullia and Tom discuss how trial teams can decide what needs review, where risk should shape scope and timing, and why unusual activity needs context before it becomes a finding. Key Takeaways Audit trail review should focus on relevant risks and questions rather than attempting to review every available event.Trial-level and system-level review can have different purposes and owners, so scope and responsibilities need to be clear.A flagged event still needs interpretation against the clinical data and study context before deciding whether action is required. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 63: Audit Trail Review in Clinical Trials

  3. Sep 4

    Episode 62: Drug Adherence and Persistence

    Drug adherence and persistence measures built from claims or EHR databases depend as much on study definitions as recorded treatment events. In this QCast episode, co-hosts Jullia and Tom explain how adherence differs from persistence, what prescribing and dispensing data can and cannot show, and how MPR, PDC, treatment-gap rules and thresholds shape the findings. Key Takeaways Adherence describes how closely medicine use follows the agreed regimen, while persistence measures how long treatment continues before discontinuation.Claims and EHR data provide useful evidence on prescriptions, dispensing and treatment changes, but neither confirms that a patient took the medicine as intended.MPR, PDC and persistence estimates depend on decisions about follow-up, days’ supply, permissible gaps, dose changes, switching and censoring. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 62: Drug Adherence and Persistence

  4. Aug 28

    Episode 61: The Role of Data Monitoring Committees (DMC) in Clinical Trials

    In this QCast episode, Jullia and Tom discuss the role of data monitoring committees, or DMCs, in clinical trials. They explain how DMCs support participant safety and trial integrity, when independent monitoring may be proportionate, and why confidential interim data needs careful handling. Key Takeaways A DMC provides independent review of accumulating trial data, especially where interim safety, efficacy, futility or benefit-risk decisions may affect study conduct.DMCs are not automatically needed for every trial. Their use should be assessed against the study’s risk profile, design, duration, blinding and planned interim decision points.Clear charters, controlled data access and independent statistical support help protect confidential interim data and reduce the risk of operational bias. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 61: The Role of Data Monitoring Committees (DMC) in Clinical Trials

  5. Aug 21

    Episode 60: Oncology Phase 1 Trial Design

    In this QCast episode, Jullia and Tom discuss how oncology Phase 1 trial design has moved beyond simply identifying the maximum tolerated dose. They look at dose optimisation, escalation methods, simulation, data readiness, expansion cohorts, biomarkers and site capability, with a focus on how these elements affect real dose decisions. Key Takeaways Safety, exposure, pharmacodynamic information, early activity and longer-term tolerability can all influence the dose and regimen taken forward.Simulation can show how a design behaves when toxicity is delayed, information is incomplete or patients are exposed to doses that are too high or too low.Adverse events, laboratory results, PK and PD data, query resolution, biomarker turnaround and site readiness can all affect whether reviews happen with the evidence expected. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 60: Oncology Phase 1 Trial Design

  6. Aug 14

    Episode 59: Clinical Data Quality

    In this QCast episode, Jullia and Tom look at how clinical data quality is shaped from study set-up through collection, review and integration. They discuss why clear definitions, well-designed data flows and proportionate quality control matter, particularly when trial data move across multiple systems or vendors. Key Takeaways Clinical data should be judged by whether they are fit for the decisions and analyses the study needs to support, rather than by cleanliness alone.Quality problems often begin upstream. CRF design, data definitions, mappings and study instructions can create issues that later queries cannot fully correct.Review effort should focus on critical data and recurring patterns. Trend review can help identify process problems that isolated record checks may miss. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 59: Clinical Data Quality

  7. Aug 7

    Episode 58: Rescue Studies

    In this QCast episode, Jullia and Tom discuss how sponsors can assess a study in difficulty, decide how to handle existing databases and data, manage handovers, and set realistic expectations for recovery. Key Takeaways A rescue assessment should identify the root cause before corrective work begins.Database rescue does not always require a rebuild.Recovery plans need to reflect what can genuinely be corrected. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 58: Rescue Studies

  8. Jul 31

    Episode 57: Clinical Trial Performance Metrics

    In this QCast episode, Jullia and Tom examine how clinical trial performance metrics can support better oversight without creating unnecessary reporting burden. They explain the difference between metrics and key performance indicators, why ownership is often shared across sponsors, CROs and sites, and how leading and lagging indicators support different decisions. Key Takeaways Select a focused set of metrics linked to clear decisions. Measuring more does not automatically improve oversight.Define ownership, calculation methods, thresholds and expected responses before reporting begins.Interpret performance in context. A positive-looking number, such as a low query count, may reflect clean data or incomplete review. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    Episode 57: Clinical Trial Performance Metrics
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About

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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