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.
Greater Clarity Starts with CDISC Education. We invite you to join us at one of our training events. You can also contact us with any questions you may have.
Jozef Aerts
Jozef Aerts is professor in Medical Informatics at the University of Applied Science FH Joanneum in Graz, Austria. He has been an active CDISC volunteer since 2002, is one of the main developers of the ODM and SDM-XML standards, and has contributed 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 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).
Course(s) Taught:
Define-XML Essentials: Mastering Metadata Definitions, Traceability Core Concepts, and Implementation Challenges, ODM ImplementationTraining Language(s):
Dutch, English, GermanConversant Language(s):
FrenchNick De Donder
Nick De Donder has a diverse work experience in the field of life sciences and data standards. Nick started working at Business & Decision Life Sciences (now Enovalife) in 2008, where he held various roles including Data Integration Specialist, Project Manager, Line Manager Data Standards, and Head of Data Standards. Recently he became an independent consultant. Since June 2021 Nick has been CDISC Open Rules Program Manager. Nick's expertise lies in data standards and he has an extensive experience in the field.
Since 2017, Nick has been a CDISC Authorized Trainer and progressively took on roles such as E3C member, E3C Chair, and PHUSE Committee member.
Course(s) Taught:
CDASH Advanced, CDASH Fundamentals, CDISC for Newcomers, SDTM Advanced, SDTM Changes and Updates (SDTM v1.7 - 2.0 and SDTMIG v3.3 - 3.4), Private Training - CDISC Open Rules Hands-On Implementation Workshop for TIGTraining Language(s):
Dutch, EnglishConversant Language(s):
FrenchGitte Frausing
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).
Course(s) Taught:
SEND ImplementationTraining Language(s):
Danish, EnglishConversant Language(s):
French, SwedishRoger Gagali Angoh
Roger Gagali Angoh is a CDISC standards specialist with over ten years of experience in the pharmaceutical industry. He has expertise in implementing and maintaining CDISC Common Terminology (CT), Study Data Tabulation Model (SDTM), Clinical Data Acquisition Standards Harmonization (CDASH), and Define.XML standards. His background includes a French Master's degree in Medicinal Chemistry and experience in clinical data management. He has led projects involving CDISC CT alignment, SDTMIG migration, Metadata Repository (MDR) consumption, sponsor SDTM-like model integration, and mapping strategy optimization. His web development skills facilitate communication between end-users and integrated solutions providers.
Course(s) Taught:
CDASH Fundamentals, SDTM Theory and ApplicationTraining Language(s):
English, FrenchConversant Language(s):
English, FrenchMonika Kawohl
Monika Kawohl is a Principal Statistical Programmer at mainanalytics 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. Through work on the ADaM metadata sub-team she also became involved with the CDISC Define-XML team and as a consequence, the Define-XML course as well as the CDISC for Newcomers course have been added recently to her CDISC classes taught list. Additionally, Monika is a member of the executive committee of the German-speaking CDISC User Network.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application, CDISC for Newcomers, Define-XML Essentials: Mastering Metadata Definitions, Traceability Core Concepts, and Implementation ChallengesTraining Language(s):
English, GermanConversant Language(s):
Ward Puttemans
Ward Puttemans is a data standards data manager and lab controlled terminology subject matter expert at SolCur outsourced to argenx. He holds a Bachelor of Bio-medical Laboratory Technology from the University Colleges Leuven-Limburg. Ward started his career at Janssen as part of liquid and parental drug development team and transitioned to clinical data manager afterwards. After working at 7 years at Janssen he moved to UCB where he manages eCRF and SDTM standards and controlled terminology. 4 years later he moved to SolCur and works as a consultant at argenx managing standards. Ward is a co-lead on the CDISC Controlled Terminology User Guide (CTUG) team, a member of the Lab SDS sub team and a CDISC instructor in Controlled Terminology.
Course(s) Taught:
CDISC for Newcomers, Controlled Terminology Module 2: CT Metadata and File Formats, Controlled Terminology AdvancedTraining Language(s):
EnglishConversant Language(s):
EnglishRajesh Saha
Rajesh has over 15 years of extensive expertise in Clinical Data Standards and Clinical Programming. He is currently the Clinical Programming Portfolio Lead at J&J. Wherein he is accountable for delivery of SDTM and DRM (Data Review Model) for his portfolios.
With a tenure of more than 5 years as a pivotal member of the Clinical Data Standards team at J&J, Rajesh maintains his status as a Standards Strategic Partner within the organization. His proficiency spans key areas of standards including CDASH, SDTM, Define.xml, ODM, and MDR solutions.
Rajesh's passion for teaching is evident through his longstanding role as a standards trainer within J&J. Additionally, he was appointed as an authorized trainer at CDISC in 2023, further underscoring his commitment to advancing industry standards and knowledge dissemination.
Course(s) Taught:
CDASH Fundamentals, SDTM Advanced, Private Training - CDISC Open Rules Hands-On Implementation Workshop for TIGTraining Language(s):
EnglishConversant Language(s):
EnglishSandeep Sawant
Based in India, Sandeep plays a key role in the formation of the CDISC user group there. He is the winner of multiple academic honors and possesses a master's degree in statistics. He has worked in data standards, statistical programming, and biostatistics for about 20 years. He is currently an Associate Director of Data Standards and Governance at Syneos Health. He has given numerous trainings and workshops on SDTM and ADaM in a variety of industry forums in India and other countries. Several industry forums have published some of his most important contributions. In 2015–16, he finished his CDISC Fellowship, and he co-wrote CFAST TAUG, which treats breast, prostate, and malaria.
Course(s) Taught:
CDASH Fundamentals, Private Training - CDISC Open Rules Hands-On Implementation Workshop for TIGTraining Language(s):
EnglishConversant Language(s):
EnglishAngelo Tinazzi
Angelo Tinazzi is Senior Director, Statistical Programming, Project Based Service (PBS), responsible for Clinical Data Standards and Data Submission, working at Cytel since 2012. Angelo has about 30 years’ of experience working with different organizations in Italy, UK, and Switzerland.
In his role at Cytel, Angelo lead data standards initiatives as well as advising clients and internal teams on best strategies for implementing data standards for submission with health authorities such as FDA, PMDA, and NMPA. He also supports applications development and automation initiatives for the Cytel PBS Statistical Programming Group.
Angelo is a CDISC ADaM Authorized Instructor and member of the CDISC European Coordinating Committee where he is also leading Italian speaking User Network.