QCast: Data-Driven Dialogue in Drug Development

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. 🔗 Learn More & Get Support: Visit quanticate.com [https://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 [https://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.

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. 🔗 Learn More & Get Support: Visit quanticate.com [https://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 [https://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.

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. 🔗 Learn More & Get Support: Visit quanticate.com [https://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 [https://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.

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. 🔗 Learn More & Get Support: Visit quanticate.com [https://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 [https://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.

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. 🔗 Learn More & Get Support: Visit quanticate.com [https://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 [https://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.