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Clinical trials are meant to generate evidence, not paperwork, but too many studies still depend on spreadsheets, duplicate data entry and unconnected systems. This episode we are joined by Karen Maduschke, a clinical trial technology leader with over 20 years of experience, from building one of the first interactive e-consent products to scaling trial tech through acquisition and entry into a global CRO environment.
Together we explore one of most pressing challenges in Clinical Trials: moving faster without sacrificing integrity. Karen breaks down why “speed” is really a workflow problem, how poor integration creates site burden and error risk, and where new technologies and automation can genuinely help. We also talk about what must come alongside that shift: validation, information security, patient privacy and clear governance to protect patients and control risk.
The episode also touches on practical tips if you are a founder selling into pharma R&D. We map the different corporate players you need to get on board and to buy into your product, not simply your technology - from clinical operations and procurement, to QA, legal, IT and information security. We also explain why pharma does not buy shiny tech, but reduced risk and faster delivery.
FInally we finish with our ever fun game show round focused this episode on "How couch was this trial?" exploring the extent to which decentralisation in trials is becoming a reality? Subscribe for more, share this with a founder or trial leader who needs it, and leave us a review with your biggest barrier to a faster, cleaner transition from Labs to Lives.
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Hosts
Alexander Booth aka the MedTech Guy
Dimitri Borisevich aka the start-up Guy
Ivanna Rosendal aka the R&D pharma Gal
