QCast: Data-Driven Dialogue in Drug Development

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 to contracts, ethics, and regulatory submissions, and explain why early choices in this phase can shape timelines, site activation, and the amount of operat...

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 assessed across different types of devices, and why study design depends so heavily on intended use, risk profile, usability, and real-world clinical context. Key...

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 help teams build an early picture of safety, tolerability, and pharmacokinetics, and why their value depends on clear escalation rules, fast data review, and...

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, where it can give sponsors more flexibility and specialist support, and why its success depends on clear scope, strong governance, and effective oversight...

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 flow, query management, and oversight, and why its value depends on strong integration, governance, and human review. Key Takeaways Understand automation as...

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 routine care data can be used to answer practical research questions, and why the value of these studies depends so heavily on clear design, data quality, a...

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, population, endpoints, and treatment effect, and why the study needs to produce data that can support a real development decision rather than just an encouraging...

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 the responder definition depends on consistent joint counts, patient-reported assessments, and timely acute phase reactants, and why a clean-looking binary...

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 practice, how early technical validation and portal expectations can derail an otherwise solid package, and where teams most often lose time through version dri...

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 oversight to site models, specialist assessments, and the way data moves from collection to review and analysis. Key Takeaways Recognise how therapeutic area choic...

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 practice, how it translates protocol requirements into usable data capture, and how to approach validation checks without overburdening sites. Key Takeaways...

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, how teams identify critical data and processes, and how KRIs and QTLs can be used to spot emerging issues early and drive proportionate, documented action a...

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 translating the evolving evidence base into practical guidance on dosing rationale, monitoring, and risk management. Key Takeaways  Understand what an Investigator’s...

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 treatment assignment as evidence accumulates, and how patient characteristics can be incorporated through covariate-adjusted response-adaptive randomisation.  K...

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....