QCast: Data-Driven Dialogue in Drug Development

Quanticate
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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.

  1. Episode 44: Clinical Trial Simulation

    HACE 6 DÍAS

    Episode 44: Clinical Trial Simulation

    In this QCast episode, co-hosts Jullia and Tom explore clinical trial simulation and how it supports better study design decisions before a trial begins. They explain how simulation uses statistical and mathematical models to test plausible study scenarios, rather than relying on a single fixed assumption. Key Takeaways Simulation helps teams see how a study design may behave under different assumptions around treatment effect, variability, dropout, recruitment, or safety.The right model depends on the question, whether that is dose selection, endpoint choice, interim planning, or operational feasibility.Simulation is most useful when scenarios reflect clinical and operational reality, with clear assumptions, verification, and communication. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    13 min
  2. Episode 43: Clinical Study Start Up

    24 ABR

    Episode 43: Clinical Study Start Up

    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 operational disruption carried into enrolment. Key Takeaways Feasibility should test whether the study can really run as planned. That means looking beyond protocol intent to site capacity, patient availability, staffing, and day-to-day operational burden.Delays in study start up do not come only from ethics or regulatory review. Budget development, contract negotiation, handoffs, and unclear ownership can quietly add significant waiting time.Start up becomes more predictable when teams treat it as a controlled process. Clear accountability, parallel work where appropriate, and measurement of cycle time and delays all help reduce avoidable slowdowns. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    10 min
  3. Episode 42: Medical Device Clinical Trials

    17 ABR

    Episode 42: Medical Device Clinical Trials

    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 Takeaways Understand medical device clinical trials as evidence-generating studies built around safety, performance, and clinical benefit in the context the device will actually be used.Plan development in stages, because device studies often evolve through feasibility, refinement, and pivotal evidence generation rather than following a standard drug-style pathway.Build strong operational control around training, traceability, and device accountability, because study credibility depends on how consistently the device is used and documented in practice. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    10 min
  4. Episode 41: What Are SAD MAD Studies?

    10 ABR

    Episode 41: What Are SAD MAD Studies?

    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 disciplined study execution. Key Takeaways Understand SAD and MAD studies as core early-phase designs used to assess single-dose and repeat-dose effects in humans.Use these studies to guide early decisions on dose escalation, accumulation, tolerability, and later dose planning.Plan review processes and operational detail carefully, because timing, data flow, and clear decision rules are critical to generating usable results. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    8 min
  5. Episode 40: Functional Service Provision (FSP)

    3 ABR

    Episode 40: Functional Service Provision (FSP)

    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. Key Takeaways Understand functional service provision as a model where sponsors outsource defined functions while retaining overall direction and oversight.Use FSP when targeted capacity, specialist expertise, or flexible support is needed in specific areas of trial delivery.Plan governance early, because clear boundaries, aligned systems, and strong communication are what make the model work well. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    13 min
  6. Episode 39: Automation in Clinical Trials

    27 MAR

    Episode 39: Automation in Clinical Trials

    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 the use of connected digital systems to support repeatable trial tasks with greater consistency and traceability.Use automation where manual handoffs, repetitive checks, and fragmented data flows are slowing quality-critical work.Keep human oversight central, because successful automation still depends on clear workflows, validation, and appropriate review. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    12 min
  7. Episode 38: Observational Studies in Clinical Trials

    20 MAR

    Episode 38: Observational Studies in Clinical Trials

    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, and careful analysis. Key Takeaways Understand observational studies as non-interventional research, where treatment decisions happen through usual care rather than study assignment.Use observational studies to examine broader populations, longer-term outcomes, treatment patterns, and other real-world questions.Plan for bias and data limitations early, because baseline differences, missing data, and timing issues can affect the conclusions. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    11 min
  8. Episode 37: Phase 2b in Clinical Trials

    13 MAR

    Episode 37: Phase 2b in Clinical Trials

    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 signal. Key Takeaways Treat phase 2b as a focused decision study, with design choices centred on whether the selected regimen, endpoint strategy, and target population are strong enough to justify the next stage of development.Use phase 2b to sharpen both the scientific and operational model, because endpoint collection, visit timing, dosing control, and missing data can all affect how confidently results can be interpreted.Plan analysis and execution with phase 3 in mind, since the effect size, variability, and practical lessons from phase 2b often shape later sample size assumptions, protocol choices, and overall development strategy. 🔗 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.

    11 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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