Shows
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 26: Medical Coding in Clinical Data ManagementIn 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 TakeawaysUnderstand how medical coding aligns adverse events, medical history, and medications using controlled dictionaries to support reliable aggregation and interpretation.Recognise why clear coding conventions, dictionary version control, and integration with safety systems are critical for audit readiness and signal detection.Apply practical best practices, including improving verbatim da...
2025-12-2209 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 25: The Proportional Odds Assumption in Clinical TrialsIn 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 TakeawaysUnderstand that proportional odds implies a single treatment effect across all cut points of an ordered endpoint, enabling an efficient summary of benefit.Examine outcome distributions, use formal tests, and compare treatment effects across thresholds to assess whether the assumption is reasonable.Plan for alternatives such as...
2025-12-1211 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 24: Health Economics and Outcomes Research (HEOR)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 TakeawaysAnchor HEOR work to a clear decision question around value, pricing, access, or policy.Match methods to the data: define cohorts carefully, respect real world data limits, and invest in strong database infrastructure and quality control.Plan for stakeholders early so analyses, documentation, and reporting meet the needs of payers, regulators, clinicians, and internal teams.đź”— L...
2025-12-0510 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 23: Query Management in Clinical TrialsIn 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 TakeawaysDefine query management as part of study design, not just an operational clean up activity.Use clear, targeted edit checks and concise query wording to reduce noise and site burden.Track meaningful metrics such as turnaround time, ageing, and queries per...
2025-11-2810 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 22: Quality Tolerance Limits in Clinical TrialsIn 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 TakeawaysDefine QTLs from the risk assessment, link them to truly critical to quality parameters.Set a small number of clear, study level limits, document rationale and calculation upfront.Embed QTLs into routine dashboards and oversight, trigger root cause analysis when breached.Build cross...
2025-11-2109 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 21: The Role of Reconciliation in Clinical Data ManagementIn 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 safety and endpoints, monitor trends.Standardise units, ranges and identifiers, enforce change control and stable keys.Automate cross-system checks and dashboards, keep audit-ready logs and reconciliation records.🔗 Learn More & Get Support...
2025-11-1412 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 20: Missing Data in Clinical TrialsIn 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 correct with simpler schedules, remote options, continued follow-up, and early action on gaps.  Use principled methods such as mixed models and multiple imputation, consider pattern-mixture approaches, avoid last observation carried forward.  Demonstrate robustness through targeted sensitivity analyses, tipping-point checks, and clear...
2025-11-0710 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 19: Data Validation in Clinical Data ManagementIn 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 TakeawaysPrioritise a lean Data Validation Plan that targets critical data, tunes top checks, controls changes and captures test evidence.Treat third-party data as first-class by standardising units and timestamps, validating imports and reconciling on a steady cadence.Connect monitoring and validation with shared dashboards, agreed thresholds and coordinated actions to focus effort and cut noise.Prove and imp...
2025-10-3112 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 18: Real World Evidence in Clinical TrialsIn 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 TakeawaysStart with the decision, emulate the target trial, and justify methods with clear diagnostics.Make data fitness and governance non-negotiable: provenance, completeness, traceability, privacy, and compliant linkage.Use RWE to complement trials; for external controls, ensure clinical comparability and robust confounding control.Build reproducible capability: curated common data models, versioned code, audit trails, and checks for biases like time zero and ov...
2025-10-2412 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 17: Dose Expansion Phases in Oncology TrialsIn 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 phase two. Key TakeawaysTreat the dose expansion phase as a structured bridge between dose finding and phase two readiness.Define clear objectives, eligibility criteria, and decision rules for each cohort to maintain sci...
2025-10-1713 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 16: Statistical Analysis Plans (SAPs)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 statistical execution.  Anchor all analyses to the estimand framework to maintain alignment and interpretability.  Finalise and version-control the SAP before data lock to prevent bias and audit issues.  Define derivations, flags, and datasets explicitly...
2025-10-1013 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 15: CRF Annotation in Clinical TrialsIn 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 TakeawaysTreat the annotated CRF as the contract between collection and analysis to ensure end-to-end traceability.Start from CDASH templates and map cleanly to SDTM; extend standards only with clear rationale.Lock units and controlled terminology early to avoid reconciliation churn and mapping gaps.Run cross-functional reviews with...
2025-10-0312 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 14: Using R Programming for Clinical Trial Data AnalysisIn 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 TakeawaysUse the language for simulations, cleaning, modelling, safety, and reporting across the trial lifecycle.Build “reporting datasets” to simplify creation of inspection-ready tables and figures.Validate processes with pinned versions, documentation, and independent review.Start small with pilot outputs, then scale once confidence and consistency are proven.Automate style elements and maintain version cont...
2025-09-2512 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 13: Estimands in Clinical TrialsIn 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 objectives, CRFs, and the analysis plan to the same question.Match intercurrent event strategy to the decision: treatment policy, composite, hypothetical, while-on-treatment, or principal stratum.Choose summary measures that aid decisions—consider restricted mean survival tim...
2025-09-1912 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 12: AI and Automation in Clinical Data ManagementIn 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 quick wins and common traps to avoid.Key TakeawaysStart small with a high-value workflow, define success measures, and scale proven patterns.Automation standardises execution; AI prioritises attention—together they surface issues earlier and speed de...
2025-09-1213 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 11: A Guide to Virtual Clinical TrialsIn 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 pitfalls that commonly derail virtual studies, and share the practical safeguards that make them work.Key TakeawaysMatch each procedure to the safest and most reliable setting; not everything should move...
2025-09-0512 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 10: Managing Clinical Data Challenges with a DSMBIn 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 confident decisions. Key TakeawaysProportional oversight keeps risk in check; higher-risk or adaptive trials benefit most from a DSMB. Keeping roles separate ensures accountability; the DSMB advises and ethics committees appr...
2025-08-2812 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 9: Randomisation in Clinical TrialsIn 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 TakeawaysRandomisation reduces bias, supports blinding, and strengthens trial validity.Simple, block, and stratified methods suit different trial sizes and needs.Unequal allocation and adaptive designs require clear rationale and oversight.Centralised systems keep assignments consistent and unpredictable across sit...
2025-08-2012 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 8: The Database Lock Process in Clinical TrialsIn 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 lock on time.Key TakeawaysDatabase lock is a formal milestone where the trial dataset becomes complete, validated, and ready for analysis.Designing for lock starts at s...
2025-08-1411 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 7: A Guide to Phase 1 Clinical Trial DesignsIn 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: it establishes pharmacokinetic and tolerability benchmarks that guide every later trial.Single ascending-dose studies map how a single dose behaves in the b...
2025-08-0808 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 6: The ALCOA++ Principles for Data Integrity in Clinical TrialsIn 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 remains clear and true to the source. The ALCOA++ extensions prevent data loss, ensure consistent sequencing, p...
2025-08-0109 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 5: CDISC Standards in Clinical ResearchIn 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 traceability through CDASH, SDTM, and ADaM backed by controlled terminology.CDISC outperforms bespoke formats by cutting manual mapping, speeding regulatory...
2025-07-2509 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 4: BOIN Design in Clinical TrialsIn 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 and safety rules.Core concepts involve setting a target toxicity rate, calculating helper rates at 60% and 140%, deriving decision limits via...
2025-07-1811 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 3: Complex Innovative Trial DesignsIn 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 borrowing, and platform vaccine trials.How CIDs deliver faster timelines, smaller sample sizes, and more ethical patient allocation.Essential preparation tips and guidelines for successful implementation.Common pitfalls to avoid, including under-powered desi...
2025-07-0311 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 2: Guide to Integrated Summaries of Safety and EffectivenessIn 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 clinicians.How regular double-checks and mock panels prevent regulatory hiccups.Ways a polished summary accelerates approval and optimises labelling.đź”— L...
2025-06-1716 min
QCast: Data-Driven Dialogue in Drug DevelopmentEpisode 1: The Use of Wearables in Clinical TrialsIn 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 dialogue, QCast explores how wearables can drive more efficient, inclusive research.đź”— Learn More & Get Support: Visit quanticate.com to explore our bio...
2025-06-0214 min
CPhI Podcast SeriesDecentralised Clinical Trial Design: Collecting Real World Data in a Remote SettingAs the world adjusts to the reality of a prolonged global pandemic, never has decentralising clinical trials become such a pertinent issue. In an interview with CRO Quanticate, we look at why decentralised trials are becoming more and more important.About the Speakers:Fabien Du Fraisse, Vice President, Account Management, QuanticateFabien Du Fraisse is the Vice President of Account Management and is responsible for overseeing the key Strategic Accounts at Quanticate. He has extensive experience in both commercial and marketing functions in the Life Science Industry, having held positions at GSK, Unilever...
2021-03-0427 min