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. Episode 27: Machine Learning in the Pharmaceutical Industry

    12/26/2025

    Episode 27: Machine Learning in the Pharmaceutical Industry

    In this QCast episode, Jullia and Tom unpack how machine learning is being applied across the pharmaceutical industry. They discuss what machine learning means in a regulated drug development context, where it is already supporting discovery, development, and trial operations, and how teams can use these methods responsibly without undermining scientific or regulatory confidence. Key Takeaways Understand how machine learning differs from traditional statistical approaches, and why it is particularly useful for prediction and pattern recognition in complex, high dimensional data.Recognise where machine learning is delivering tangible benefits across discovery, clinical trials, and real world evidence, while remaining subject to the same data integrity and governance expectations as other methods.Apply practical best practices, including starting with clear questions, investing in data quality and validation, and balancing model performance with transparency to support trust and regulatory acceptance. 🔗 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 min
  2. Episode 26: Medical Coding in Clinical Data Management

    12/22/2025

    Episode 26: Medical Coding in Clinical Data Management

    In this QCast episode, Jullia and Tom explore medical coding in clinical data management, clarifying how clinical narratives are translated into standardised terminology, why consistent coding underpins safety review and regulatory confidence, and how coding decisions shape analysis-ready datasets across a study’s lifecycle. Key Takeaways Understand how medical coding aligns adverse events, medical history, and medications using controlled dictionaries to support reliable aggregation and interpretation.Recognise why clear coding conventions, dictionary version control, and integration with safety systems are critical for audit readiness and signal detection.Apply practical best practices, including improving verbatim data quality, coding continuously rather than at the end of a study, and maintaining transparent oversight to reduce rework and risk. 🔗 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 min
  3. Episode 25: The Proportional Odds Assumption in Clinical Trials

    12/12/2025

    Episode 25: The Proportional Odds Assumption in Clinical Trials

    In this QCast episode, Jullia and Tom unpack the proportional odds assumption in ordinal logistic regression, explaining what it means in practice, why it matters for ordinal endpoints in clinical trials, and how to diagnose and handle violations without losing the value of ordered scales. Key Takeaways Understand that proportional odds implies a single treatment effect across all cut points of an ordered endpoint, enabling an efficient summary of benefit.Examine outcome distributions, use formal tests, and compare treatment effects across thresholds to assess whether the assumption is reasonable.Plan for alternatives such as partial proportional odds or more flexible models, and document the rationale so methods and interpretations remain transparent to clinicians and regulators. 🔗 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 min
  4. Episode 24: Health Economics and Outcomes Research (HEOR)

    12/05/2025

    Episode 24: Health Economics and Outcomes Research (HEOR)

    In this QCast episode, Jullia and Tom explore health economics and outcomes research, explaining how outcomes research looks beyond controlled trials to real world care and how HEOR evidence informs pricing, reimbursement, and access decisions. Key Takeaways Anchor HEOR work to a clear decision question around value, pricing, access, or policy.Match methods to the data: define cohorts carefully, respect real world data limits, and invest in strong database infrastructure and quality control.Plan for stakeholders early so analyses, documentation, and reporting meet the needs of payers, regulators, clinicians, and internal teams. 🔗 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 min
  5. Episode 23: Query Management in Clinical Trials

    11/28/2025

    Episode 23: Query Management in Clinical Trials

    In this QCast episode, Jullia and Tom unpack query management in clinical trials, outlining what queries are, how they move from detection to closure, and how thoughtful design, clear communication, and focused metrics turn them from administrative noise into a practical quality tool that protects data integrity, timelines, and inspection readiness. Key Takeaways Define query management as part of study design, not just an operational clean up activity.Use clear, targeted edit checks and concise query wording to reduce noise and site burden.Track meaningful metrics such as turnaround time, ageing, and queries per subject to focus improvements. 🔗 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 min
  6. Episode 22: Quality Tolerance Limits in Clinical Trials

    11/21/2025

    Episode 22: Quality Tolerance Limits in Clinical Trials

    In this QCast episode, Jullia and Tom explore quality tolerance limits in clinical trials, explaining what they are, how they support risk based quality management, and how to define, monitor and govern them so they genuinely protect participant safety and trial integrity rather than becoming a tick box exercise. Key Takeaways Define QTLs from the risk assessment, link them to truly critical to quality parameters.Set a small number of clear, study level limits, document rationale and calculation upfront.Embed QTLs into routine dashboards and oversight, trigger root cause analysis when breached.Build cross functional governance, review trends, update QTLs as the trial and risks evolve. 🔗 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 min
  7. Episode 21: The Role of Reconciliation in Clinical Data Management

    11/14/2025

    Episode 21: The Role of Reconciliation in Clinical Data Management

    In this QCast episode, Jullia and Tom unpack data reconciliation in clinical data management — what it is, why it underpins data integrity and safety oversight, and how to plan, run, and document it so analyses reflect the truth across clinical, safety, and vendor systems.  Key Takeaways  Map streams early, set owners and cadence, lock vendor specifications.Prioritise high-risk data such as safety and endpoints, monitor trends.Standardise units, ranges and identifiers, enforce change control and stable keys.Automate cross-system checks and dashboards, keep audit-ready logs and reconciliation records. 🔗 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.

    13 min
  8. Episode 20: Missing Data in Clinical Trials

    11/07/2025

    Episode 20: Missing Data in Clinical Trials

    In this QCast episode, Jullia and Tom unpack missing data in clinical trials — why it biases effect estimates, how the estimand framework drives prevention and analysis choices, and what good sensitivity work and reporting look like for credible, inspection-ready results. Key Takeaways  Define estimands and intercurrent-event strategies, then align follow-up and data collection.  Prevent over correct with simpler schedules, remote options, continued follow-up, and early action on gaps.  Use principled methods such as mixed models and multiple imputation, consider pattern-mixture approaches, avoid last observation carried forward.  Demonstrate robustness through targeted sensitivity analyses, tipping-point checks, and clear summaries of missingness and reasons.  🔗 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 min
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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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