QCast: Data-Driven Dialogue in Drug Development

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 food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutting timelines without sacrificing data quality. Key TakeawaysPhase 1 is more than a basic safety check:

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 practice across paper, electronic, and hybrid systems.Key TakeawaysALCOA++ is your data backbone, defining ten attributes that keep every record reliable, auditable, and long-lasting.The original ALCOA pillars ensure every entry shows who did what, when, and

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 with faster regulatory approvals, lower costs, and analytics-ready datasets.Key TakeawaysCDISC standards are a unified set of content and exchange models for collecting, structuring, and submitting clinical trial data.Their core concepts include end-to-end

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 call it 'fit for purpose,' and how sponsors are using it to speed up dose-finding while keeping patient safety front and centre.Key TakeawaysBOIN design is a model-assisted Bayesian dose-escalation method with pre-defined escalation, de-escalation

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 boosting efficiency, personalisation, and speed.Key TakeawaysWhat makes a trial 'complex and innovative': adaptive rules, Bayesian borrowing, and seamless master protocols.Four CID categories: traditional adaptive, biomarker-guided, Bayesian

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 approve new drugs and devices.Key TakeawaysHow pooling trial data uncovers rare safety issues and confirms efficacy.Best practices for standardising data collection and formats early.Strategies for seamless collaboration between statisticians, programmers, and

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 study designs.Key TakeawaysHow decentralised, patient-centric study designs boost engagement.Best practices for integrating and validating wearable data.Strategies to enhance data quality and streamline operations.Where biometric expertise meets data-driven