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
67 episodes
Episode 67: The Analysis of Direct and Indirect Pathways in Observational Studies
In this episode, Jullia and Tom discuss direct and indirect pathways in observational studies, with a focus on mediation analysis and what it can, and cannot, show. Using an ankylosing spondylitis example, they look at how fatigue, anxiety/depr...
Episode 66: What is Clinical Traceability?
Clinical traceability is about being able to follow evidence from a reported result back to its source and understand the transformations, decisions, and records in between. In this QCast episode, co-hosts Jullia and Tom discuss how traceabilit...
Episode 65: Clinical Trial Trends Shaping Modern Drug Development
Clinical trial trends matter most when they affect how studies are designed, delivered, and overseen. In this QCast episode, co-hosts Jullia and Tom discuss how decentralised models, AI, real-world evidence, adaptive designs, RBQM, outsourcing,...
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 ...
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 unusu...
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 pre...
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 c...
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, b...
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 matte...
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...
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 own...
Episode 56: Bayesian Clinical Trial Design
In this QCast episode, co-hosts Jullia and Tom explain how priors, posterior probabilities and predictive probabilities support clinical decisions. They also discuss external data borrowing, adaptive trial features, simulation, regulatory expec...
Episode 55: What is Adaptive Trial Design?
In this QCast episode, Jullia and Tom examine how adaptive trial design allows pre-specified changes to a clinical trial using accumulating interim data. They look at common adaptations, including early stopping, sample size re-estimation and d...
Episode 54: SAS vs R vs Python in Clinical Trials
In this QCast episode, Jullia and Tom look at SAS vs R vs Python through the lens of clinical trial delivery. Rather than treating the choice as a programming preference, they focus on where each tool tends to fit: SAS for established clinical ...
Episode 53: Decentralised Clinical Trials
In this QCast episode, Jullia and Tom discuss decentralised clinical trials and what they mean for clinical development teams in practice. The episode looks at decentralisation as a spectrum of remote, local, digital, and site-based activity, r...
Episode 52: The Global Statistical Test for Multiple Endpoint Analysis
In this QCast episode, Jullia and Tom discuss the Global Statistical Test for multiple endpoints analysis and why it can be useful when a clinical trial needs to assess more than one outcome at the same time. They cover the problem of testing e...
Episode 51: CDASH Standards and Conformance in Clinical Data Management
In this QCast episode, Jullia and Tom discuss CDASH standards and conformance in clinical data management, with a focus on where CDASH sits in the clinical data flow and why it matters before data reaches SDTM. The episode looks at CRF and eCRF...
Episode 50: Multi-Omics Application in Personalised Medicine Studies
In this QCast episode, Jullia and Tom discuss multi-omics and its application in personalised medicine studies. The episode explains how genomic, transcriptomic, proteomic, metabolomic and other biological data layers can be analysed together t...
Episode 49: BIMO Listings
In this QCast episode, Jullia and Tom discuss BIMO listings and their role in FDA inspection readiness. They explain how Bioresearch Monitoring looks at clinical trial conduct, participant protection, data credibility, and the records that supp...
Episode 48: Efficacy Endpoints in Oncology Clinical Trials
In this QCast episode, Jullia and Tom discuss efficacy endpoints in oncology clinical trials and why endpoint choice shapes how treatment benefit is assessed. They look at overall survival, progression-free survival, objective response rate, di...
Episode 47: The Creation of ADaM Datasets for PK Analysis
In this QCast episode, Jullia and Tom discuss how ADaM datasets are created for pharmacokinetic, or PK, analysis. They look at the role of ADPC for concentration data and ADPP for derived PK parameters, including how these datasets relate to SD...
Episode 46: What is Clinical Data Review?
In this QCast episode, Jullia and Tom discuss clinical data review as an active part of study oversight, rather than a late-stage clean-up exercise. They explore how timely, connected review supports subject safety, data quality, medical review...
Episode 45: Clinical Trial Management Systems (CTMS)
In this QCast episode, Jullia and Tom discuss clinical trial management systems and their role in keeping clinical studies under control. They explain how CTMS differs from EDC, why operational visibility matters across recruitment, monitoring,...
Episode 44: Clinical Trial Simulation
In this QCast episode, co-hosts Jullia and Tom explore clinical trial simulation and how it supports better study design decisions before a trial begins. They explain how simulation uses statistical and mathematical models to test plausible stu...
Episode 43: Clinical Study Start Up
In this QCast episode, co-hosts Jullia and Tom explore clinical study start up and why it has such a direct effect on how a trial runs once sites begin opening. They look at what study start up actually includes, from feasibility and budgeting ...
