Afleveringen
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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Zijn er afleveringen die ontbreken?
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
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.
Key Takeaways
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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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.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom unpack ACR response criteria in rheumatoid arthritis clinical trials and why these endpoints are more operationally demanding than they look on paper. They explain what ACR20, ACR50, and ACR70 measure, how the responder definition depends on consistent joint counts, patient-reported assessments, and timely acute phase reactants, and why a clean-looking binary endpoint can still carry composite-style risks.
Key Takeaways
Protect the core ACR components at site level, especially tender and swollen joint counts, visit windows, and lab turnaround, because missing or late elements can block endpoint classification.Build derivations and reporting to reflect the ACR hierarchy so ACR70 implies ACR50 and ACR20, avoiding avoidable inconsistencies in outputs.Plan early for how you will use repeated assessments, whether through repeated measures, curve-focused approaches, or overall summaries like weighted differences or GEE, and be clear on how results will be interpreted.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom explore regulatory submissions in clinical trials and why strong submission discipline protects timelines long before any scientific review begins. They discuss what a regulatory submission includes in practice, how early technical validation and portal expectations can derail an otherwise solid package, and where teams most often lose time through version drift, misaligned dependencies, and avoidable publishing and metadata errors.
Key Takeaways
Treat technical validation readiness as a core delivery task and align early to authority and portal expectations.Lock versions and track knock-on updates across protocols, informed consent, and supporting documents to prevent internal contradictions.Run publishing dry runs, focus validation on severity and impact, and confirm metadata and identifiers align across datasets and submission files.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom unpack therapeutic areas in clinical research and why they matter far beyond a clinical label. They discuss how a therapeutic area shapes trial design assumptions, from endpoint selection and safety oversight to site models, specialist assessments, and the way data moves from collection to review and analysis.
Key Takeaways
Recognise how therapeutic area choice influences endpoint strategy, safety review cadence, site workflows, and vendor needs from the earliest planning stages.Anticipate where execution risk often appears first, including inconsistent endpoint measurement, unrealistic feasibility assumptions, and fragile multi-source data flow.Plan for newer modalities and technology-enabled studies by tightening the chain from data collection to review, with clear integration, monitoring responsibilities, and proportionate oversight.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom break down eCRF design in clinical trials and why it has such an outsized impact on data quality, site workload, and downstream analysis. They clarify what an electronic case report form is meant to do in practice, how it translates protocol requirements into usable data capture, and how to approach validation checks without overburdening sites.
Key Takeaways
Understand what eCRF design is and how it supports consistent, high-integrity data capture in an electronic data capture system.Learn practical design principles that reduce queries and rework, including clear structure, field-level clarity, and proportionate edit checks.Apply a simple mindset for modern studies that depend on external data, focusing on integration planning, validation, and reconciliation from the outset.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom unpack risk-based quality management (RBQM) in clinical data management and why itโs central to protecting participant safety and the reliability of trial results. They clarify what RBQM means in practice, how teams identify critical data and processes, and how KRIs and QTLs can be used to spot emerging issues early and drive proportionate, documented action across functions.
Key Takeaways
Understand what RBQM is in a clinical data management context, and how it focuses oversight on critical-to-quality data and processes.Learn how KRIs and QTLs are used day to day, including how to avoid 'metric noise'. Apply practical steps to keep RBQM effective through delivery when risks span data management and operations.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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In this QCast episode, Jullia and Tom break down the Investigatorโs Brochure (IB) and why it remains a cornerstone of safe, consistent trial conduct. They explain what an IB is, who relies on it, and how it complements the protocol by translating the evolving evidence base into practical guidance on dosing rationale, monitoring, and risk management.
Key Takeaways
Understand what an Investigatorโs Brochure is, who itโs for, and how it supports risk and benefit assessment alongside the protocol. Learn what makes an IB usable in practice, including clear structure, concise summaries, and actionable guidance for investigators. Apply practical safeguards, from keeping IB and protocol aligned to managing RSI, version control, and timely updates when significant new safety information emerges.
๐ Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
๐ Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
๐ 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.
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