Instructor: Niels Both
Company: S-Cubed
Courses Taught: SDTM, ADaM
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 and has also been active in e3c the European CDISC Co-ordination Committee.
Instructor: Kit Howard
Company: CDISC
Courses Taught: SDTM, SDTM for Devices, CDASH
Kit Howard has been on the CDASH Leadership Team since CDASH’s early days, and has been a CDASH trainer since the course was developed. She also worked on the CDASH User Guide. She currently co-leads the Medical Devices Standards team, and was instrumental in producing the SDTM Supplement for Medical Devices. In addition, Kit is a CDISC Registered Solutions Provider.
Kit is the owner of Kestrel Consultants and is a recognized expert in clinical data management, quality and standards with almost 30 years of experience. She provides consulting and training services for biopharma, medical device, academic and regulatory organizations. She holds a graduate degree in Clinical Research Design and Statistical Analysis, is a certified clinical data manager and serves on the Society for Clinical Data Management’s Editorial Board.
Instructor: Shannon Labout
Company: CDISC
Courses Taught: SDTM, CDASH, Legacy Data Conversion
Shannon Labout is a Certified Clinical Data Manager (CCDM) with 20+ years experience in healthcare technologies, project management and clinical research. She has managed clinical data management teams in both the U.S. and Europe, and has participated in CRF standardization, and contributed to data standards development, harmonization and implementation at multiple global pharmaceutical organizations and CROs for more than a decade. She has been an active member and team lead on the CDASH team since 2006 and on the SDS team since 2007. Shannon has been training on CDISC standards in North America, Europe and Asia since 2007. She is currently Vice President, Education at CDISC.
Instructor: Lauren Shinaberry
Company: Business & Decision Life Sciences
Courses Taught: SDTM, CDASH
Lauren is a Certified Clinical Data Manager with over 15 years experience in data management, programming and project management. She has managed clinical and statistical programming teams in both North America and Europe and developed CRF standards for an international CRO as well as several client organizations. In 2006 she moved from the US to the United Kingdom and in 2011 relocated to Belgium where she is currently a project manager at Business & Decision Life Sciences helping clients implement CDISC standards within their organizations. Lauren is the 2012 Chair of the CDISC Advisory Board and is part of the CDASH Leadership Team. She provides CDASH and SDTM training throughout Europe.
Instructor: Peter van Reusel
Company: Business & Decision Life Sciences
Courses Taught: SDTM, Global Approach to Accelerating Medical Research, Legacy Data Conversion
Peter started his career with Janssen Pharmaceutica, a Johnson & Johnson pharmaceutical company. He started working as a database analyst and over the years became responsible for the Janssen Pharmaceutica global data standard. Peter Van Reusel is the Business Unit Director of the CRO Services. His team is specialized in CDISC data standards and statistical programming. Peter is currently also one of the CDISC SDTM instructors, delivering courses across Europe. Peter is a member of the CDISC E3C committee and the CDISC Advisory Board.
Instructor: Gary Walker
Company: Quintiles
Courses Taught: SDTM, CDASH
Gary Walker has worked in the pharmaceutical industry since 1992 and tells people his career path took the proverbial "scenic route." He started in IT and moved to Research and Development IT, supporting CANDA (Computer Assisted New Drug Applications) submissions. He subsequently moved to Regulatory Affairs and Publishing where Gary helped to create numerous marketing applications and supplements in electronic format from 1997 through 2005. In 2001, while working in regulatory, Gary became a member of the CDISC SDS team. In 2005 Gary moved from regulatory to Data Standards within Quintiles’ Global Data Management department. In this role, Gary supported CDISC standards for data preparation within Data Management and Biostatistics, both for submission using SDTM and in the data collection and cleaning processes of Data Management, through the adoption of SDTM-friendly variables and the use of SDTM naming fragments for non-standard variables. Gary joined the CDASH initiative in 2006 and led the Demographics domain team for version 1.0. Gary continues to actively participate on the work on many of the CDISC standards including SDTM, CDASH and CDISC SHARE. Gary currently work for Quintiles in Innovation, a group focused on new and innovative products, where he is a part of a team focused on EHR data use for clinical research.