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 32: Risk-Based Quality Management in CDM

    3D AGO

    Episode 32: Risk-Based Quality Management in CDM

    In this QCast episode, Jullia and Tom unpack risk-based quality management (RBQM) in clinical data management and why it’s central to protecting participant safety and the reliability of trial results. They clarify what RBQM means in practice, how teams identify critical data and processes, and how KRIs and QTLs can be used to spot emerging issues early and drive proportionate, documented action across functions. Key Takeaways Understand what RBQM is in a clinical data management context, and how it focuses oversight on critical-to-quality data and processes.Learn how KRIs and QTLs are used day to day, including how to avoid 'metric noise'. Apply practical steps to keep RBQM effective through delivery when risks span data management and operations. 🔗 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.

    12 min
  2. Episode 31: Investigator's Brochure (IB)

    JAN 30

    Episode 31: Investigator's Brochure (IB)

    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. 🔔 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
  3. Episode 30: Adaptive Randomisation in Clinical Trials

    JAN 23

    Episode 30: Adaptive Randomisation in Clinical Trials

    In this QCast episode, Jullia and Tom unpack adaptive randomisation in clinical trials and why teams consider it when fixed allocation feels inefficient or ethically uncomfortable. They explain how response-adaptive randomisation can shift treatment assignment as evidence accumulates, and how patient characteristics can be incorporated through covariate-adjusted response-adaptive randomisation.  Key Takeaways Understand what adaptive randomisation is, how it differs from fixed randomisation, and where response-adaptive approaches fit in modern trial design.Learn how baseline covariates and biomarkers can be used to tailor allocation in a controlled way, and why predictive signals matter more than simple risk stratification.Apply practical safeguards, including clear decision rules, realistic simulation planning, and strong governance around interim data and operational delivery. 🔗 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
  4. Episode 29: What is Clinical Data Management?

    JAN 16

    Episode 29: What is Clinical Data Management?

    In this QCast episode, Jullia and Tom break down what clinical data management is and why it’s essential to reliable trial decisions. They explain how clinical data management supports patient safety and data integrity from study start-up through to database lock, covering core activities like CRF design, database build, validation checks, query management, reconciliation of external data, and inspection-ready documentation. Key Takeaways Understand what clinical data management covers end to end, and how it protects both patient safety and the credibility of trial results.Recognise the key components of clinical data management in practice, including the CDMS and its wider ecosystem, and how standards support consistent, analysis-ready data.Apply practical best practices, including investing early in CRF and database design, and making the data management plan operational. 🔗 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.

    10 min
  5. Episode 28: Real World Data Analysis in Clinical Trials

    JAN 9

    Episode 28: Real World Data Analysis in Clinical Trials

    In this QCast episode, Jullia and Tom unpack how real world data is analysed to complement clinical trials. They clarify the difference between real world data and real world evidence, explore the main data sources and their trade-offs, and explain how these datasets support trial decisions across feasibility, effectiveness in routine care, and longer-term safety. Key Takeaways Understand the difference between real world data and real world evidence, and why real world analysis is increasingly used to add scale, context, and longer follow-up alongside trials.Recognise the strengths and limitations of common real world data sources, including EHRs, claims, registries, labs, and patient-generated data. Apply practical best practices, including pre-specifying definitions and algorithms and documenting assumptions. 🔗 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
  6. 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
  7. 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
  8. 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
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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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