In this episode, Jullia and Tom explore randomisation in clinical trials including why it matters, key methods, and how to keep allocations consistent.
In this episode, Jullia and Tom break down the database lock process in clinical trials–what it is, why it matters, and how to avoid last-minute chaos.
In this episode, Jullia and Tom unpack Phase 1 clinical trial designs, the first-in-human studies that establish safety, pharmacokinetics and tolerability.
In this episode, Jullia and Tom explore the ALCOA++ Principles, the core attributes that safeguard data integrity in clinical trials from first observation to final archive.
In this episode, Jullia and Tom unpack CDISC standards in clinical research, exploring content models, exchange formats, and how to streamline your trials.
In this episode, Jullia and Tom unpack Complex Innovative Trial Designs (CIDs), exploring how adaptive and Bayesian methods are transforming clinical research.
In this episode, Jullia and Tom explore how companies pool trial data into clear safety and efficacy packages regulators need to approve new drugs and devices.