CDISC instructors come from a variety of professional backgrounds and are located across seven countries and three continents. Our instructors work for pharmaceutical companies, CROs, consultancy firms, academic institutions and undergo a rigorous qualification process to teach CDISC-authorized courses.
Jozef Aerts is professor in Medical Informatics at the University of Applied Science FH Joanneum in Graz, Austria. He is also an active CDISC volunteer since 2002, and one of the main developers of the ODM and SDM-XML standards, with also contributions to other standards and CDISC documents such as define.xml and the Metadata Submission Guide.
Jozef is also owner and CEO of XML4Pharma, a software development and consultancy company specializing in implementation of CDISC standards (CDISC Registered Solutions Provider) and well known for its ODM and define.xml editing, viewing and checking tools, and for its ODM to SDTM mapping software.
In his sparse free time, Jozef likes to climb mountains in the Alps - he is also a mountaineering instructor for the German Alpine Club (DAV).
Anne-Sophie Bekx started her career in the pharmaceutical industry in 2009 after obtaining a master’s degree in Biomedical Sciences from the Université Libre de Bruxelles. She currently works at Janssen Pharmaceutica as an Associate Director for Medical Affairs, managing a team of global data managers working on post-submission trials and real-world evidence.
Prior to that she worked as the Line Manager for the Data Standards team at the CRO Business & Decision Life Sciences (BDLS). In this role she was responsible for the operational management of the project teams and personnel working within the CDISC Data Standards & Implementation department of the BDLS CRO. This team works to create CDISC compliant data standards libraries (CDASH, SDTM, ADaM and SEND) as well as CDISC-compliant, submission-ready packages for FDA and PMDA submissions.
She has been an authorized CDISC SDTM and CDASH trainer since January 2016 and has also contributed to the creation of the Vaccines Reactogenicity TAUG.
Having worked for more than 15 years within the different areas of clinical data flow ranging from collection to statistical analysis and submission, Niels Both provides training in CDISC standards, coupled with a unique understanding of the everyday problems encountered when submitting data in SDTM, define.xml or ADaM to FDA.
For the last 4 years, Niels has been working as Principal consultant for S-cubed, assisting companies across Europe implementing CDISC standards e2e ranging from CDASH over SDTM to ADaM.
Niels has been active in the CDISC community for almost 10 years, presenting CDISC at road-shows, conferences and other events.
Dorina Bratfalean has more than 20 years of experience as a researcher in biotechnology in academia and private biotech companies working on different European Project Frameworks (FP5, FP6, FP7). Dorina holds a PhD in Computer-aided Bioprocess Engineering in Chemical Engineering from Babes Bolyai University, Faculty of Chemistry and Chemical Engineering, in Cluj-Napoca, Romania.
In 2010, she became senior data manager in the fields of biomarker development and translational medicine. She has developed eCRFs by implementing the CDASH model and has developed ETL SDTM data integration models throughout more than 60 clinical studies in various patient populations to validate markers of liver, kidney, and cardiovascular toxicities.
In 2014, Dorina joined the CDISC European Foundation team to work on IMI projects as a data standards adviser. Dorina is an active member in the CDISC Protocol Terminology team, CDISC SDTMIG for Pharmacogenomics/Genetics team (PGx), and the Therapeutic Area Data Standards User Guide for Vaccines team. She is also a member in the tranSMART community standards working group to develop the representation of clinical data trees as a CDISC SDTM model in tranSMART i2b2.
Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and since 2008 has been employed by Business & Decision Life Sciences at their headquarters in Brussels. He first worked in the CRO as a Data Integration Specialist, with responsibilities for the creation of SDTM annotated CRFs, defining the mapping of the conversion process to produce SDTM datasets based on legacy data, the creation of the Define-XML and the complete quality process. After a couple of years he became a Project Manager for conversion projects. After eight years, he became Line Manager for the Data Standards team, where he is responsible for the overall management of the team, ensuring the continuity and training of new staff. Nick is a member of the SDS team for the development of the new standards and a PhUSE committee member since 2017.
Gitte Frausing is Principal Consultant in Data Standards Decisions where she is working with companies implementing CDISC standards across the world. With her background in toxicology, she specializes in nonclinical and laboratory data with unique insight in the end-to-end data flow processes and brings this rare perspective and expertise to every client.
Gitte is a long-standing member of the CDISC SEND team. She has lead several efforts as a sub-team leader within the SEND team and has contributed to a substantial part of version 3.0 of the SEND Implementation guide as well as the next release (version 3.1).
Monika Kawohl is a Principal Statistical Programmer at HMS Analytical Software GmbH in Germany and has 25 years of experience in the pharmaceutical industry. Her daily work includes the hands-on application of CDISC standards towards e-submission as well as consulting clients regarding their implementation of SDTM, ADaM and Define-XML. Monika joined the ADaM team in 2009 and has served as a CDISC authorized ADaM Instructor since 2012. She is the current lead of the ADaM metadata sub-team. Since work on metadata is very much related to Define-XML, Monika also became a member of the CDISC Define-XML team and has just been appointed as CDISC authorized Define-XML instructor. She is also a member of the executive committee of the German-speaking CDISC User Network.
Éanna Kiely is the lead CDISC Consultant at ClinBuild and he volunteers to CDISC on behalf of Syneos Health.
He has been working with CDISC standards since 2008 in a variety of functions including Data Manager, Data Standards Librarian, SDTM Legacy Data Mapper and Line Manager/Product Owner of CDISC based Metadata Repository. He has led 2 CDASH/SDTM Standards Implementation and Governance projects and has been a CDASH/SDTM/EDC SME on 4 others for both Pharma and CROs across Europe.
He has been volunteering with CDISC since 2013 when he joined the SDS Questionnaires Ratings and Scales (QRS) sub-team and published a number of QRS Supplements and worked on projects. He joined the CDASH team in 2015 to work on CDASHIG 2.0 and Model 1.0 on which he is an author. He is currently a member of the Extended SDS Leadership team and an author on the forthcoming SDTMIG 3.3. He has taken part in a number of SDS projects and is currently leading the SDTM Lab Units representation team. Most recently he joined the Controlled Terminology (CT) Lab Units team and is an Authorized CDISC CT Instructor in Training.
He is a member of the European CDISC Coordinating Committee and CDISC UK User Group where he helps organize the European Interchange, CDISC UK Events and frequently presents.
Angelo has more than 20 years of experience in the field of Clinical Research in the area of Data-Management and Statistical Programming with different roles in Academic Organizations, CROs and Pharmaceutical Industries, in Italy, Switzerland and the UK.
The application of CDISC standards in different therapeutic areas is part of his core expertise since 2003 in particular in the context of data submission to health authorities such as the FDA and PMDA.
Angelo is a member of the CDISC ADaM Team as well as the CDISC European Committee where he is responsible of the Italian-speaking CDISC User Network.
Angelo is Italian, living in France and working in Geneva, Switzerland as Director of Clinical Data Standard and Data Submission, in the Statistical Programming group of Cytel Inc.
Johannes is a Principal Consultant at S-Cubed focusing on standardization and standards governance, helping clients to create sustainable CDISC deliverables. Before joining S-Cubed he was the SDTM Development Team Lead, leading a global team of SDTM experts in the AstraZeneca standards organization. The work included governing, developing and implementing SDTM standards within the company, as well as contributing to other standards development internally to have an end-to-end alignment when moving towards more CDISC adaption. He is a member of the CDISC Definitions Team.
Peter Van Reusel is passionate about data standards and implementation solutions that work. He is an advocate for CDISC and loves complex challenges.
He started his career as a database designer at Janssen Pharmaceutica, originally designing and installing clinical databases, later on taking responsibility as a data steward to ensure consistency of database structures between US and European counterparts. In 2003, he started working at Tibotec, where he helped implement industry standards, such as the CDISC models. Tibotec was one of the first companies to successfully perform a native CDISC submission.
In 2007, Peter started the Business & Decision Life Sciences CRO, which is highly specialized in CDISC Data Standards. Over the years, Peter and his team supported many companies in converting clinical legacy data for regulatory submissions. In addition, he is involved in a variety of CDISC implementation projects.
Peter is a certified CDISC SDTM and CDASH trainer since 2008, delivering CDISC trainings and expertise all over Europe. In addition he is the chair of the European CDISC Coordinating Committee, responsible for organizing the European CDISC Interchange.
In 2016, Peter has ended his role in the as a CRO Director and has refocused his career to providing his data standards implementation expertise to various companies.