QCast Episode 51: CDASH Standards and Conformance in Clinical Data Management
In this episode, Jullia and Tom discuss CDASH standards and conformance in CDM, focusing on where it sits in clinical data flow before data reaches SDTM.
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QCast Episode 50: Multi-Omics Application in Personalised Medicine Studies
In this episode, Jullia and Tom discuss how genomic, transcriptomic, proteomic, metabolomic and other biological data layers can be analysed together.
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QCast Episode 49: BIMO Listings
In this episode, Jullia and Tom discuss BIMO listings and their role in FDA inspection readiness.
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QCast Episode 48: Efficacy Endpoints in Oncology Clinical Trials
In this episode, Jullia and Tom discuss efficacy endpoints in oncology clinical trials and why endpoint choice shapes how treatment benefit is assessed.
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QCast Episode 47: The Creation of ADaM Datasets for PK Analysis
In this episode, Jullia and Tom discuss how ADaM datasets are created for pharmacokinetic, or PK, analysis.
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QCast Episode 46: What is Clinical Data Review?
In this episode, Jullia and Tom discuss clinical data review as an active part of study oversight, rather than a late-stage clean-up exercise.
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QCast Episode 45: Clinical Trial Management Systems (CTMS)
In this episode, Jullia and Tom discuss clinical trial management systems and their role in keeping clinical studies under control.
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QCast Episode 44: Clinical Trial Simulation
In this episode, Jullia and Tom explore clinical trial simulation and how it supports better study design decisions before a trial begins.
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QCast Episode 43: Clinical Study Start Up
In this episode, 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.
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QCast Episode 42: Medical Device Clinical Trials
In this episode, Jullia and Tom explore medical device clinical trials and why they differ in important ways from drug studies.
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