CLINICAL DATA MANAGEMENT

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? 

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. 

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.

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!

S02E01 Luke Woodham - computer scientist @ St George’s University of London

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.

Adam Chee - health informatician @ Smart Health Leadership Centre - National University of Singapore

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!

Jaroslav Koca - principal clinical data manager @ Cytel

The 7th episode focuses on the EDC systems and their impact on the quality of data. It features Mr. Jaroslav Koca - an experienced clinical data manager with a background in computational biology, who is now affiliated with Cytel as a principal clinical data manager.  Let's listen to some of his experience with electronic data capture systems and also with other tools used not only by data managers but also by investigators and clinical trial coordinators. Let's get inspired by someone who can recognize the importance of clinical data managers and what they can do with the data before giving them to biostatisticians. Why make things easy if you can complicate them? It sounds like a silly question, but everything is possible in a world full of shortcuts!

Tomas Machulka - Premier Research

The sixth episode focuses on the very specific role of a data manager within interdisciplinary communication in clinical research projects. It features Mr. Tomas Machulka who is now affiliated with Premier Research as an associated manager for clinical data sciences. He serves also as a senior consultant for CZECRIN - the Czech part of the European Clinical Research Infrastructure Network.  Let's listen to some of his experience with risk-based quality management and queries. Let's get inspired by someone who is able to recognize the importance of an EDC system in a tech ecosystem used by data managers. Who is telling the truth? Feel free to ask your data manager, who has the role of a criminal detective!

Richard Hulek - computer scientist @ RECETOX

The fifth episode focuses on data integrity and also on data integration in long cohort studies. It features Richard Hulek - a computer scientist with a background in environmental informatics, experienced in the integration of systems behind long cohort studies. Let's listen to his opinions on how computer scientists may contribute to the education of data analysts. Let's learn something new about DBT - a promising transformation data tool and let's not forget SQL - the basic language of data. Be inspired by the concept of exposomics - the systematic determination of links between environment and human health.
 

Antoine Pironet - medical data scientist @ AARDEX Group

The fourth episode focuses on data quality in clinical research, and how it relates to medication adherence. It features Antoine Pironet - a data scientist with a background in biomedical engineering, experienced in analyzing data collected in national registries and data in electronic medical adherence systems. Let's listen to some of his experience with the analysis of medical adherence data. Let's learn about patients' behavior and how they may influence the final results in clinical trials in terms of computed efficacy. Let's get inspired by measuring medication adherence instead of harassing patients.