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
22 episodes
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
Episode 14: Using R Programming for Clinical Trial Data Analysis
In this QCast episode, Jullia and Tom break down how the R programming language is being used for clinical trial data analysis. They explore its role across the trial lifecycle, from planning and cleaning through efficacy, safety, and reporting...
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Episode 14
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12:28
Episode 13: Estimands in Clinical Trials
In this QCast episode, Jullia and Tom demystify estimands and show how a clear question, defined up front, sharpens trial design, data capture, and analysis. They unpack the four elements, explain practical strategies for handling intercurrent ...
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Episode 13
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12:08
Episode 12: AI and Automation in Clinical Data Management
In this QCast episode, Jullia and Tom explain how AI and automation make clinical data work smoother from smarter screening and electronic consent to streaming device data, auto-summarising notes, targeted monitoring, and faster reports. They o...
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Episode 12
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13:23
Episode 11: A Guide to Virtual Clinical Trials
In this QCast episode, Jullia and Tom explore the rise of virtual clinical trials—what they are, when they work best, and how to design them without compromising safety or data quality. They cover the regulatory expectations across the US, EU, ...
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Episode 11
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12:51
Episode 10: Managing Clinical Data Challenges with a DSMB
In this QCast episode, Jullia and Tom uncover how Data and Safety Monitoring Boards (DSMBs) keep trials safe and on track—what they are, when you need one, and how to avoid data pitfalls at interim looks. They unpack the DSMB charter versus the...
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Episode 10
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12:03
Episode 9: Randomisation in Clinical Trials
In this QCast episode, Jullia and Tom break down randomisation in clinical trials—why it matters, how different methods work, and what safeguards keep allocations fair and consistent across sites. They cover simple, block, and stratified random...
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Episode 9
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12:23
Episode 8: The Database Lock Process in Clinical Trials
In this QCast episode, join co-hosts Jullia and Tom as they unpack the database lock process in clinical trials. You’ll get a clear explanation of what a lock is, why it matters, and the difference between soft and hard locks. They’ll walk thro...
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Episode 8
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11:55
Episode 7: A Guide to Phase 1 Clinical Trial Designs
In this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how foo...
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Episode 7
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8:26
Episode 6: The ALCOA++ Principles for Data Integrity in Clinical Trials
In this QCast episode, join co-hosts Jullia and Tom as they explore the ALCOA++ Principles for clinical trial data integrity. You'll get clear definitions of the five original ALCOA pillars, the new additions, and learn how to put them into pra...
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Episode 6
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9:37
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 wit...
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Episode 5
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9:26
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 ca...
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Episode 4
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11:12
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 ...
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Episode 3
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11:24
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 a...
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Episode 2
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16:07
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 ...
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Episode 1
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14:14
