QCast: Data-Driven Dialogue in Drug Development

Quanticate
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  • SCIENCE DE LA VIE

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.

  1. Episode 15: CRF Annotation in Clinical Trials

    -1 J

    Episode 15: CRF Annotation in Clinical Trials

    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 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 data management, programming, statistics, and safety before go-live.Manage changes with controlled versions, dated effective changes, and clear training for sites.Document external data sources and transformation notes in the aCRF to unify all acquisition channels.Avoid free text where coded lists fit, and annotate conditional logic to prevent false “missing” patterns. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    13 min
  2. Episode 14: Using R Programming for Clinical Trial Data Analysis

    25 SEPT.

    Episode 14: Using R Programming for Clinical Trial Data Analysis

    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 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 control to ensure reproducibility. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
  3. Episode 13: Estimands in Clinical Trials

    19 SEPT.

    Episode 13: Estimands in Clinical Trials

    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 decision: treatment policy, composite, hypothetical, while-on-treatment, or principal stratum.Choose summary measures that aid decisions—consider restricted mean survival time when hazards are non-proportional.Select an estimator that truly targets the estimand and pre-specify two or three focused sensitivity analyses.Avoid pitfalls: do not conflate missing data with intercurrent events, and prevent inconsistencies across protocol, SAP, and data capture.  🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
  4. Episode 12: AI and Automation in Clinical Data Management

    12 SEPT.

    Episode 12: AI and Automation in Clinical Data Management

    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 Takeaways Start 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 decisions.Interoperability and governance matter most: integrate core systems, enforce role-based access, encryption, and complete audit trails.Quick wins include NLP-assisted coding and simple RBM rules; benchmark against a baseline to show impact.Treat models like regulated components: document purpose and training data, validate performance, monitor over time, and revalidate when processes change. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    13 min
  5. Episode 11: A Guide to Virtual Clinical Trials

    5 SEPT.

    Episode 11: A Guide to Virtual Clinical Trials

    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 pitfalls that commonly derail virtual studies, and share the practical safeguards that make them work. Key Takeaways Match each procedure to the safest and most reliable setting; not everything should move off-site.Regulators expect clear PI oversight, data integrity controls, and proportionate monitoring.Technology must be validated, user-friendly, and backed by strong audit trails and contingency plans.Inclusion requires more than access; design choices and support determine who can truly participate.A risk-based assessment, mapped data flows, and realistic fallbacks are the fastest way to build resilience. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    13 min
  6. Episode 10: Managing Clinical Data Challenges with a DSMB

    28 AOÛT

    Episode 10: Managing Clinical Data Challenges with a DSMB

    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 confident decisions.  Key Takeaways Proportional 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 approve changes. The charter sets rules for the board, while the monitoring plan guides day-to-day safety review. Strong data discipline such as aligned entry targets, reconciled external feeds, protected blinding, and a rehearsed packet keeps interim looks clean.Clear, pre-agreed data flows and decision language prevent delays and accidental unblinding. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
  7. Episode 9: Randomisation in Clinical Trials

    20 AOÛT

    Episode 9: Randomisation in Clinical Trials

    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, 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 sites.Strong planning, role separation, and quality control ensure reliable execution. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
  8. Episode 8: The Database Lock Process in Clinical Trials

    14 AOÛT

    Episode 8: The Database Lock Process in Clinical Trials

    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 Takeaways Database lock is a formal milestone where the trial dataset becomes complete, validated, and ready for analysis.Designing for lock starts at study setup, with data management and biostatistics aligning on eCRF design and validation rules that support analysis.Soft locks (data freezes) allow final checks and fixes before a hard lock, which is the final, audit-ready closure of the database.Good data hygiene such as real-time entry, regular listings review, and timely vendor reconciliations avoids a last-minute backlog.A shared lock plan with milestones, named owners, and a thorough checklist keeps hand-offs smooth and makes the lock process predictable and efficient. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. 🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode. About Quanticate Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in: Clinical Data Capture & Management Biostatistics & Statistical Consultancy Statistical Programming & PK/PD Analysis Medical Writing & Pharmacovigilance Regulatory & Submission Support AI & Automation Post-Marketing Safety & Real-World Data Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
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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.

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