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.
Episodes
39 episodes
Episode 39: Automation in Clinical Trials
In this QCast episode, Jullia and Tom explore automation in clinical trials and why it matters for modern study delivery. They explain what automation looks like in day-to-day trial work, where it can reduce manual burden across consent, data f...
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Episode 39
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12:02
Episode 38: Observational Studies in Clinical Trials
In this QCast episode, Jullia and Tom explore observational studies and why they remain such an important part of the evidence base in drug development. They explain what makes an observational study different from an interventional trial, how ...
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Episode 38
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11:01
Episode 37: Phase 2b in Clinical Trials
In this QCast episode, Jullia and Tom explore phase 2b in clinical trials and why this stage plays such a decisive role in moving a programme towards phase 3. They explain how phase 2b is typically used to reduce uncertainty around dose, popula...
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Episode 37
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11:01
Episode 36: ACR Response Criteria in Rheumatoid Arthritis Trials
In this QCast episode, Jullia and Tom unpack ACR response criteria in rheumatoid arthritis clinical trials and why these endpoints are more operationally demanding than they look on paper. They explain what ACR20, ACR50, and ACR70 measure, how ...
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Episode 36
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11:08
Episode 35: Regulatory Submissions in Clinical Trials
In this QCast episode, Jullia and Tom explore regulatory submissions in clinical trials and why strong submission discipline protects timelines long before any scientific review begins. They discuss what a regulatory submission includes in prac...
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Episode 35
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11:16
Episode 34: Therapeutic Areas in Clinical Research
In this QCast episode, Jullia and Tom unpack therapeutic areas in clinical research and why they matter far beyond a clinical label. They discuss how a therapeutic area shapes trial design assumptions, from endpoint selection and safety oversig...
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Episode 34
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11:56
Episode 33: eCRF Design in Clinical Trials
In this QCast episode, Jullia and Tom break down eCRF design in clinical trials and why it has such an outsized impact on data quality, site workload, and downstream analysis. They clarify what an electronic case report form is meant to do in p...
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Episode 33
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11:19
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, ...
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Episode 32
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11:30
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 translati...
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Episode 31
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11:29
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 trea...
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Episode 30
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12:49
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 throu...
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Episode 29
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9:44
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 exp...
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Episode 28
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9:18
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, d...
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Episode 27
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10:45
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, ...
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Episode 26
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9:29
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 violatio...
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Episode 25
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11:28
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....
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Episode 24
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10:43
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 administra...
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Episode 23
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10:54
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 participan...
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Episode 22
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9:04
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...
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Episode 21
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12:47
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 credibl...
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Episode 20
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10:48
Episode 19: Data Validation in Clinical Data Management
In this QCast episode, Jullia and Tom demystify data validation in clinical data management — how a lean, risk-based approach safeguards data integrity and supports confident database lock, inspection readiness, and downstream SDTM and ADaM del...
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Episode 19
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12:38
Episode 18: Real World Evidence in Clinical Trials
In this QCast episode, Jullia and Tom unpack real-world evidence in modern drug development — what distinguishes real-world data from the evidence it enables, and how to apply it alongside randomised trials.Key Takeaways
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Episode 18
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12:02
Episode 17: Dose Expansion Phases in Oncology Trials
In this QCast episode, Jullia and Tom explore the dose expansion phase of phase one oncology trials — the critical bridge between dose finding and proof of concept. They discuss how expansion cohorts confirm safety, explore early efficacy signa...
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Episode 17
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13:12
Episode 16: Statistical Analysis Plans (SAPs)
In this QCast episode, Jullia and Tom unpack Statistical Analysis Plans (SAPs) — the blueprints that define how clinical trial data are turned into evidence. They explore what a SAP includes, how it links to the protocol and estimand framework,...
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Episode 16
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13:41
Episode 15: CRF Annotation in Clinical Trials
In this QCast episode, Jullia and Tom demystify case report form annotation in clinical trials. They explain what an annotated CRF is, why it is central to traceability and compliance, and how teams use CDASH at collection and SDTM at tabulatio...
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Episode 15
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12:30
