x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

PODCAST

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.

science life sciences

All Episodes

12:38

Episode 19: Data Validation in Clinical Data Management

QCast: Data-Driven Dialogue in Drug Development ·

2025/10/31

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 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

en-gb

12:02

Episode 18: Real World Evidence in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/10/24

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 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

en-gb

13:12

Episode 17: Dose Expansion Phases in Oncology Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/10/17

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 phase two. Key TakeawaysTreat the dose expansion phase as a structured bridge between dose finding and

en-gb

13:41

Episode 16: Statistical Analysis Plans (SAPs)

QCast: Data-Driven Dialogue in Drug Development ·

2025/10/10

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

en-gb

12:30

Episode 15: CRF Annotation in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/10/03

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 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

en-gb

12:28

Episode 14: Using R Programming for Clinical Trial...

QCast: Data-Driven Dialogue in Drug Development ·

2025/09/25

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 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,

en-gb

12:08

Episode 13: Estimands in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/09/19

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 objectives, CRFs, and the analysis plan to the same question.Match intercurrent event strategy to the

en-gb

13:23

Episode 12: AI and Automation in Clinical Data...

QCast: Data-Driven Dialogue in Drug Development ·

2025/09/12

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 quick wins and common traps to avoid.Key TakeawaysStart small with a high-value workflow, define success

en-gb

12:51

Episode 11: A Guide to Virtual Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/09/05

In this QCast, 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

en-gb

12:03

Episode 10: Managing Clinical Data Challenges with a...

QCast: Data-Driven Dialogue in Drug Development ·

2025/08/28

In this QCast, 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

en-gb

12:23

Episode 9: Randomisation in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/08/20

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 TakeawaysRandomisation reduces bias, supports blinding, and strengthens trial validity.Simple, block, and stratified methods suit different

en-gb

11:55

Episode 8: The Database Lock Process in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/08/14

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 lock on time.Key TakeawaysDatabase lock is a formal milestone where the trial dataset becomes complete,

en-gb

8:26

Episode 7: A Guide to Phase 1 Clinical Trial Designs

QCast: Data-Driven Dialogue in Drug Development ·

2025/08/08

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:

en-gb

9:37

Episode 6: The ALCOA++ Principles for Data Integrity...

QCast: Data-Driven Dialogue in Drug Development ·

2025/08/01

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

en-gb

9:26

Episode 5: CDISC Standards in Clinical Research

QCast: Data-Driven Dialogue in Drug Development ·

2025/07/25

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

en-gb

11:12

Episode 4: BOIN Design in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/07/18

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

en-gb

11:24

Episode 3: Complex Innovative Trial Designs

QCast: Data-Driven Dialogue in Drug Development ·

2025/07/03

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

en-gb

16:07

Episode 2: Guide to Integrated Summaries of Safety...

QCast: Data-Driven Dialogue in Drug Development ·

2025/06/17

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

en-gb

14:14

Episode 1: The Use of Wearables in Clinical Trials

QCast: Data-Driven Dialogue in Drug Development ·

2025/06/02

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

en-gb

19 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter