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CDASH

Instructor: Kit HowardInstructor: Kit Howard

Company: CDISC

Courses Taught: CDASH, SDTM, Device SDTM

 

 

 

Kit Howard has been on the CDASH Leadership Team since CDASH’s early days, and has been a CDASH instructor 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 LaboutInstructor: Shannon Labout

Company: CDISC

Courses Taught: CDASH, SDTM, 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 ShinaberryInstructor: Lauren Shinaberry

Company: Business & Decision Life Sciences

Courses Taught: CDASH, SDTM

 

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: Alec VardyInstructor: Alec Vardy

Company: Affymax

Courses Taught: CDASH

 

 

Alec Vardy has more than 30 years experience in the pharmaceutical industry, beginning in Biostatistics, and finally “converting” to Clinical Data Management in 1998.  He has worked for large pharmaceutical companies, large and small CROs, small biotechnology companies, and his career has taken him from The Netherlands to California, via England, Pennsylvania, and Texas.  

 

Alec participated in his first standards initiative in 1986, when his company adopted the integrated Clinical Study Report (prior to that time, many companies issued separate clinical and statistical reports for the same study).  Since then, he has been involved in many standards projects.  Alec joined the CDASH Leadership team in January 2007, and (when his “day job” has permitted) has contributed to the initial standards document and the User Guide, as well as the alignment of CDASH with Terminology.

 

 

 

 

Instructor: Gary WalkerInstructor: Gary Walker

Company: Quintiles

Courses Taught: CDASH, SDTM

 

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.