QCast: Data-Driven Dialogue in Drug Development

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 through to database lock, covering core activities like CRF design, database build, validation checks, query management, reconciliation of external data, and ins...

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 explain how these datasets support trial decisions across feasibility, effectiveness in routine care, and longer-term safety. Key Takeaways Understand the diff...

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, development, and trial operations, and how teams can use these methods responsibly without undermining scientific or regulatory confidence. Key Takeaways Und...

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, and how coding decisions shape analysis-ready datasets across a study’s lifecycle. Key Takeaways Understand how medical coding aligns adverse events, medica...

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 violations without losing the value of ordered scales. Key Takeaways Understand that proportional odds implies a single treatment effect across all cut points of an...

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. Key Takeaways Anchor HEOR work to a clear decision question around value, pricing, access, or policy. Match methods to the data: define cohorts carefully,...

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 administrative noise into a practical quality tool that protects data integrity, timelines, and inspection readiness. Key Takeaways Define query management as part of...

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 participant safety and trial integrity rather than becoming a tick box exercise. Key Takeaways Define QTLs from the risk assessment, link them to truly critical to qu...

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, safety, and vendor systems.  Key Takeaways  Map streams early, set owners and cadence, lock vendor specifications. Prioritise high-risk data such as safet...

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 credible, inspection-ready results. Key Takeaways  Define estimands and intercurrent-event strategies, then align follow-up and data collection.   Prevent over cor...

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 deliverables.  Key Takeaways Prioritise a lean Data Validation Plan that targets critical data, tunes top checks, controls changes and captures test evidence....

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 Start with the decision, emulate the target trial, and justify methods with clear diagnostics. Make data fitness and governance non-negotiable: provenance, completeness, traceabi...

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 signals, and refine dose and schedule decisions, along with best practices for design, governance, and regulatory alignment that set the stage for a successful p...

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, and the controls that keep analyses credible, reproducible, and inspection-ready.  Key Takeaways  Treat the SAP as the bridge between protocol intent and s...

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 tabulation to keep mappings clean. Key Takeaways Treat the annotated CRF as the contract between collection and analysis to ensure end-to-end traceability. Start fro...

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. Key Takeaways Use the language for simulations, cleaning, modelling, safety, and reporting across the trial lifecycle. Build “reporting datasets” to simpl...

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 events, and discuss picking summary measures that clinicians and payers can interpret. Key Takeaways  Define the estimand early and in plain language; align...

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 outline the basics for linking core trial systems, clarify what regulators expect on validation and audit trails, and share a simple first-year plan with qui...

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, and UK, walk through a participant’s journey in a decentralised model, explain how oversight, technology, and logistics must align for success, highlight pi...

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 Data Safety Monitoring Plan, translate stopping boundaries into plain English, and share practical tactics for clean, blinded packages that enable confiden...

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 randomisation, touch on unequal allocation and adaptive designs, and share a practical case study from a 5-arm trial.  Key Takeaways Randomisation reduces bias, s...

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 through the planning steps that keep the final weeks on track, the habits that reduce last-minute issues, and the cross-functional coordination needed to reach...

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 cutt...

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 Takeaways ALCOA++ is your data backbone, defining ten attributes that keep every record reliabl...

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 Takeaways CDISC standards are a unified set of content and exchange models for...