CLINICAL DATA MANAGEMENT

In this episode of Clinical Data Management Best Practices, Daniel Schwarz (IBA) talks with Diego Costa Pinto (NOVA IMS), coordinator of the European CHOICE project, about health literacy, decision support, and the role of reliable data infrastructure in helping patients make informed healthcare decisions. Diego’s work sits at the crossroads of data science, behavioral science, and consumer–technology interaction—focused on a simple challenge: contributing to the community by helping people actually understand and act on complex information when it matters most.  From research in AI for social impact to health behavior and public policy projects, he brings a real-world lens to a key question: how do we turn complex health data into decisions patients can trust? Together, they explore how the future of healthcare depends on more than technology—it depends on making information understandable, usable, and human. They also discuss how conditions are not constant, and how context matters = varies worldwide.

The founder of DQ Pursuit, Subhan Huseynov, helps organizations take control of their business data. He does this through standards for identifying, managing, and correcting critical data, integrated into the DQ Pursuit knowledge-based learning concept and tool. Listen as Subhan explains why he built his business on a simple but powerful belief: "If you know your data, you know everything. If you don’t know your data, you know nothing." Discover how he — and DQ Pursuit tools — can help you truly understand and trust your data, and learn what he considers to be the key bottlenecks in software and in AI-driven systems.

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? 

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. 

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.

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!

Introducing the second season opener of the IBA podcast program on the best practices in clinical data management! In this episode, we explore the similarities and differences between data in healthcare provision and healthcare education. Our guest speaker, Luke Woodham, a computer scientist from the Center for Technology and Education at St George's University of London, offers a fresh perspective on data management. Having worked with medical students, developed data standards for authoring and sharing virtual patients, and created databases and software for law libraries, Luke provides insights into the diverse applications of data management.

The eighth episode focuses on digital health and how the messy data in healthcare can be tamed with data standards and vocabularies. It features Dr. Adam Chee - an expert in health informatics with additional backgrounds in public health and business, who is now serving as the head of Smart Health Leadership Centre at the National University of Singapore.  Let's listen to someone who never stops learning and serves as one of a few WHO experts for the area of digital health. Let's get inspired by someone who can recognize the importance of structured data not only in health informatics, but also in clinical research. ...Because it is obvious that having some form of structured data (i.e. HL7, SNOMED-CT, DICOM etc.) is better than data with no structure!