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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S03E01 Mariana Sampaio Lança - clinical research activist & professional
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?
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S02E04 Lucie Špatenková, Radek Špatenka – managing director and CEO @ Clinical Research Center s.r.o.
Lucie Špatenková is a key manager at Clinical Research Center s.r.o. Lucia has made significant contributions to medical science, leading projects that impact patient care and research in Czech republic and Slovakia.
Radek Špatenka is the CEO of Clinical Research Center s.r.o. (CRC) Radek is a visionary leader whose work is revolutionizing the landscape of clinical research.
Both, Lucie and Radek, change a the view of drug testing in Czech republic and Slovakia.
Whether you're in the medical profession or simply intrigued by the power of research, join us for an inspiring conversation with this dynamic duo, pioneers in their field.
If you want to know the answers to the following questions … In what ways is the CRC's approach different from that of its competitors? How can CRC help physicians involved in decentralised clinical trials? What are the features they are looking for while working with EDC system? Why and how sponsors in the healthcare, medical device or pharmaceutical industry should decide between small specialized companies and large CROs?
… be sure to listen to this podcast episode with these leading figures in the field.
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S02E03 Ales Tichopad - promoter of evidence-based decisions in healthcare & founder @ CEEOR
Ales Tichopad – biologist, biostatistician and founder of CEEOR- discusses the evolving role of data in healthcare and research. There is a lingering skepticism towards using AI tools, like ChatGPT, due to uncertainties regarding data handling, preferring human involvement in initial data analysis stages. The discussion shifts to the Electronic Data Capture (EDC) system CLADE-IS, which the speaker's team uses extensively. The tool is praised for its user-friendly interface, efficiency, and affordability, and distinguishes itself by being designed by clinical professionals, making it apt for real-world evidence research. The episode wraps up with a dive into the "Shedding Light into Health" initiative, aiming to promote evidence-based healthcare decisions driven by accurate data usage.
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S02E02 Ali Al Alak - medical doctor & director of clinical data management @ Speda
Diving into the dynamic world of clinical research data automation, this episode features Dr. Ali Al Alak, a young medical doctor from Copenhagen with extensive experience in clinical research. Now serving as the director of clinical data management at Speda, Dr. Al Alak shares invaluable insights into the challenging aspects of handling data in clinical research and the importance of automation. Speda, a cutting-edge platform, is redefining clinical research data management by automating various processes. This not only expedites the workflow but also enhances the reliability and security of data. Join us as we explore the pivotal role that automation plays in eliminating manual redundancies, and how this technological shift is shaping the future of clinical research data management. Let's get inspired by someone who effortlessly merges medical expertise with innovation to usher in a new era of efficiency in clinical research data management!
It is Clinical Data Management Best Practices podcast by IBA. Scientists need professional Data managers and Tools to be able to make the right decisions and establish their hypotheses correctly. We bring you interviews with leading specialists in Data Management, Biotechnology, Life Sciences, and Digital Health.
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