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
49 episodes
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 ...
Episode 42: Medical Device Clinical Trials
In this QCast episode, Jullia and Tom explore medical device clinical trials and why they differ in important ways from drug studies. They explain what these trials are designed to show, how safety, performance, and clinical benefit are assesse...
Episode 41: What Are SAD MAD Studies?
In this QCast episode, Jullia and Tom explore SAD and MAD studies and why they play such a central role in early clinical development. They explain what single ascending dose and multiple ascending dose studies are designed to show, how they he...
Episode 40: Functional Service Provision (FSP)
In this QCast episode, Jullia and Tom explore functional service provision and why it remains such an important outsourcing model in clinical development. They explain what FSP means in practical terms, how it differs from full-service delivery...
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...
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 ...
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...
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 ...
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...
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...
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...
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, ...
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...
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...
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...
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...
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...
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, ...
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...
