S03E02 AI-generated – but validated like your best EDC tools

In this special episode, two AI-generated hosts—one male, one female—dive into the world of clinical data management, offering a clear and engaging conversation on what makes data "healthy" in today's clinical trials. Despite being synthetically voiced, everything discussed is grounded in real-world documentation and certified practice. The episode unpacks how systems like CLADE-IS®, developed by the Institute of Biostatistics and Analyses (IBA), meet the highest standards of quality and security—relevant especially for Clinical Trial Units (CTUs) operating within the ECRIN (European Clinical Research Infrastructure Network). You’ll hear about: (i) Why CLADE-IS, a validated EDC/CTMS platform, is trusted across ECRIN-certified studies. (ii) The role of IBA as a CRO and data center with ECRIN, ISO, and EHDEN certifications. (iii) Built-in features like risk-based monitoring, anomaly detection via machine learning, and audit trails. (iv) How certification, structured release cycles, and regulatory alignment contribute to dependable and interoperable clinical systems Yes, it’s a bit of a product placement—but one with substance. If you're navigating complex clinical data landscapes, this episode may be your shortcut to clarity.

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