From Patient Care to Digital Data Strategies – Sébastian Wischlen, consultant at CSP in Switzerland, shares his unique journey from nursing to clinical data management and strategic consultancy.

In this episode, Sébastian reflects on the evolution from paper records to modern EDC systems, emphasizing the importance of blending technology with human expertise. He also highlights the challenges hospitals face with data infrastructure and the need for robust strategies to manage it effectively.

Looking ahead, Sébastian discusses how AI and digital health initiatives are set to revolutionize clinical data management, paving the way for more efficient and accurate healthcare solutions.

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.

Mariana is a biomedical engineer with expertise in pharmaceutical medicine and an MBA. Marianna has been active in clinical research for over than ten years – worked as a Clinical Research Associate (CRA), held the management roles, including Chief Technology Officer (CTO) and director. Currently, Mariana excels in clinical project management and freelance consulting.

Mariana's extensive experience in clinical operations and data management underscores the importance of high-quality data in clinical trials. In her work with major pharmaceutical companies and Contract Research Organizations (CROs), she ensures that the research projects meet their objectives through meticulous data collection and management.

Join us as Mariana shares her insights into clinical research and the critical role of data management. Specifically:

- tech or people … that’s not the question, but why?

- data manager and statistician should work very closely together and sit in the same house, or are those separable activities?