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 52: The Global Statistical Test for Multiple Endpoint Analysis

    12 hrs ago

    Episode 52: The Global Statistical Test for Multiple Endpoint Analysis

    In this QCast episode, Jullia and Tom discuss the Global Statistical Test for multiple endpoints analysis and why it can be useful when a clinical trial needs to assess more than one outcome at the same time. They cover the problem of testing endpoints separately, how GST supports an overall assessment of treatment effect, and why endpoint choice, correlation, missing data, and clinical interpretation need to be planned before the analysis is run. Key Takeaways Multiple endpoints can give a fuller view of treatment effect, but testing them separately increases the chance of false positive findings.GST can provide one overall assessment across a related set of endpoints, while still requiring endpoint-level review to understand what is driving the result.GST works best when endpoints answer a shared clinical question, move in a consistent expected direction, and are supported by clear analysis planning. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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
  2. Episode 51: CDASH Standards and Conformance in Clinical Data Management

    19 June

    Episode 51: CDASH Standards and Conformance in Clinical Data Management

    In this QCast episode, Jullia and Tom discuss CDASH standards and conformance in clinical data management, with a focus on where CDASH sits in the clinical data flow and why it matters before data reaches SDTM. The episode looks at CRF and eCRF design, naming conventions, metadata, controlled terminology, ePRO and eSource data, and the practical problems that can appear when collection standards are applied too late. Key Takeaways CDASH applies at the point of data collection. It helps teams collect clinical trial data consistently before it is mapped into SDTM for review and submission.Conformance depends on more than including the right fields. Naming conventions, metadata and traceability all affect whether data can move cleanly from capture through to SDTM.Early alignment reduces avoidable rework. Bringing data management and programming into CRF design can help prevent repeated queries, unclear site responses and manual review issues later. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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 50: Multi-Omics Application in Personalised Medicine Studies

    12 June

    Episode 50: Multi-Omics Application in Personalised Medicine Studies

    In this QCast episode, Jullia and Tom discuss multi-omics and its application in personalised medicine studies. The episode explains how genomic, transcriptomic, proteomic, metabolomic and other biological data layers can be analysed together to better understand disease, treatment response and patient subgroups. Key Takeaways Multi-omics brings together several types of biological information to help researchers understand disease and treatment response more clearly than a single data layer can provide.Multi-omics can support biomarker discovery, patient stratification and exploratory analysis, but findings need clear evidence before they can guide treatment, diagnosis or prevention.Sample timing, visit labels, subject identifiers, protocol deviations and data quality checks all influence whether multi-omics data can be linked meaningfully to clinical outcomes. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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
  4. Episode 49: BIMO Listings

    5 June

    Episode 49: BIMO Listings

    In this QCast episode, Jullia and Tom discuss BIMO listings and their role in FDA inspection readiness. They explain how Bioresearch Monitoring looks at clinical trial conduct, participant protection, data credibility, and the records that support regulatory submissions. The episode also covers common misconceptions, including the idea that BIMO is only a site-level concern, and shows how sponsors can use inspection findings to strengthen oversight before issues become harder to resolve. Key Takeaways BIMO oversight looks beyond final datasets. It considers how data was collected, reviewed, documented, and supported by source records.BIMO listings can highlight patterns around protocol deviations, informed consent, adverse event reporting, data management, and submission readiness.Good preparation depends on timely data entry, clear query handling, documented decisions, version control, and records that can be retrieved and explained. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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
  5. Episode 48: Efficacy Endpoints in Oncology Clinical Trials

    29 May

    Episode 48: Efficacy Endpoints in Oncology Clinical Trials

    In this QCast episode, Jullia and Tom discuss efficacy endpoints in oncology clinical trials and why endpoint choice shapes how treatment benefit is assessed. They look at overall survival, progression-free survival, objective response rate, disease-free survival, event-free survival, symptom endpoints, and quality-of-life measures. Key Takeaways Overall survival remains one of the clearest measures of patient benefit, but it can require longer, larger trials and may be affected by treatments given after the study therapy.Progression-free survival and objective response rate can show treatment activity earlier, but they answer different questions from overall survival.Scan timing, missed assessments, censoring decisions, symptom questionnaires, and quality-of-life completion rates can all affect endpoint interpretation. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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
  6. Episode 47: The Creation of ADaM Datasets for PK Analysis

    22 May

    Episode 47: The Creation of ADaM Datasets for PK Analysis

    In this QCast episode, Jullia and Tom discuss how ADaM datasets are created for pharmacokinetic, or PK, analysis. They look at the role of ADPC for concentration data and ADPP for derived PK parameters, including how these datasets relate to SDTM PC and PP. The episode also covers why timing, dosing information, analysis values, flags and study-specific rules matter when preparing PK data for reporting and review. Key Takeaways ADPC supports PK concentration data, while ADPP supports derived PK parameters such as Cmax, Tmax, AUC and half-life. Both datasets help turn PK data into an analysis-ready structure.PK results depend on the relationship between dosing and sample collection. Planned and actual time points, relative time variables and pre-dose samples all need careful handling.Analysis values, flags and criteria variables help show which records were analysed, which were excluded and why. This makes PK outputs easier to review and reproduce. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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.

    9 min
  7. Episode 46: What is Clinical Data Review?

    15 May

    Episode 46: What is Clinical Data Review?

    In this QCast episode, Jullia and Tom discuss clinical data review as an active part of study oversight, rather than a late-stage clean-up exercise. They explore how timely, connected review supports subject safety, data quality, medical review and confident decision-making, especially as trial data now comes from EDC, ePRO, eCOA, labs, imaging, biomarkers, wearables and other sources. Key Takeaways Good review helps teams spot patterns, missing context and signals that may affect trial conduct or subject safety before issues become embedded.A lab result, adverse event or dosing change becomes more useful when it can be reviewed alongside related data at the right point in the study.Dashboards, alerts and automation can help focus attention, but teams still need clear ownership, escalation routes, traceability and risk-based priorities. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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
  8. Episode 45: Clinical Trial Management Systems (CTMS)

    8 May

    Episode 45: Clinical Trial Management Systems (CTMS)

    In this QCast episode, Jullia and Tom discuss clinical trial management systems and their role in keeping clinical studies under control. They explain how CTMS differs from EDC, why operational visibility matters across recruitment, monitoring, site activity and documentation, and how a well-used system can support risk-based oversight, audit trails and better decision-making across sponsors, CROs and sites. Key Takeaways A CTMS gives study teams a central view of milestones, site activation, monitoring activity, recruitment, documents, payments and follow-up actions.When CTMS connects with systems such as EDC, eTMF, safety platforms and finance tools, teams can reduce duplicate entry and work from a more reliable operational picture.The right CTMS should reflect real trial workflows, support current guidance expectations around oversight, and help teams act earlier when risks or delays appear. ๐Ÿ”— Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. ๐Ÿ“ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast. ๐Ÿ”” 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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About

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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