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Authorized Instructors

Jozef Aerts

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).


Courses Taught:
Define-XML
ODM Implementation

Training Languages:
Dutch, English, German
Conversant Languages:
French

Kiyomi Ando

Kiyomi Ando is a clinical data manager (CDM) with 15+ years of experience working in a global pharmaceutical company, a Japanese pharmaceutical company, and a Japanese clinical research organization (CRO).  She has been in charge of data management in 50+ clinical studies and has designed 20+ CRFs.  She has participated in the CRF standardization project in a global pharmaceutical company.  Kiyomi has implemented CDISC Standards in a CRO and a pharmaceutical company in Japan since 2005.  She has also experience as a clinical research associate in a global pharmaceutical company and as a pharmacist in hospital.  She has knowledge of the process from data acquisition in hospital to study data tabulation for submission.


Courses Taught:
CDASH Implementation

Training Languages:
Japanese
Conversant Languages:


Yoshihiro Aoyagi

Yoshihiro Aoyagi is the section head in Information Technology Management Section at National Cancer Hospital East in Japan. His main areas of expertise are system integration of infrastructure, data management and consultation for clinical trial systematization. He developed various information systems such as open source EDC system or Remote SDV system to improve utilization of information resource in the hospital. Yoshihiro has also researched the usage of hospital information system data and estimate its reliability and transparency. Previously, he had worked for clinical pharmacist drug information specialist.


Courses Taught:
CDASH Implementation

Training Languages:
Japanese
Conversant Languages:


Lauren Becnel

Lauren Becnel focuses on informatics technologies at CDISC, including our metadata repository, SHARE, which houses all CDISC standards. Dr. Becnel works at the intersections of clinical research, translational research and healthcare, ensuring the standards remain relevant for regulated research, academic research centers and precision medicine. She has over 10 years’ experience in biomedical informatics and research IT, with seven years’ experience leading large, diverse technical teams and a high-performance research computing center at Baylor School of Medicine where she served as Assistant Professor in the Departments of Medicine, Hematology/Oncology Section, and Molecular and Cellular Biology. For the past four years, she has served on the Steering Committee of the collaborative BRIDG Translational Research Domain Analysis Model (CDISC, HL7 and ISO, NCI and FDA), which harmonizes the CDISC Foundational Standards.


Courses Taught:
BRIDG Deep Dive
Introduction to BRIDG

Training Languages:
English
Conversant Languages:


Anne-Sophie Bekx

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.

 


Courses Taught:
CDASH Implementation
SDTM Theory and Application

Training Languages:
English, French
Conversant Languages:
Dutch

Niels Both

 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.


Courses Taught:
ADaM Primer
ADaM Theory and Application
SDTM Theory and Application

Training Languages:
Danish, English
Conversant Languages:
Swedish

Dorina Bratfalean

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.


Courses Taught:
SDTM Theory and Application

Training Languages:
English, Romanian
Conversant Languages:
French

Sally Cassells

Sally Cassells is the owner of Next Step Clinical Systems LLC a consulting company focused on facilitating the process of implementing CDISC standards. Sally was a founding member of the CDISC XML Technologies team and still volunteers as a team co-lead. She participates as a DefineXML team representative in the ADaM Metadata Team in the CAB Validation Project and on the Customer Advisory Board Validation Project. She is an ODM certified instructor. Prior to founding Next Step, Sally spent 8 years at Lincoln Technologies, Phase Forward and Oracle where she was the business and development lead for WebSDM and Empirica Study. Sally has over 25 years experience developing and implementing commercial clinical research software applications.


Courses Taught:
Define-XML
ODM Implementation

Training Languages:
English
Conversant Languages:


Yoshiteru Chiba

Yoshiteru has been implementing CDISC standards using ODM and SDTM since 2008. These implementation activities include creating a link from the hospital electronic health record (EHR) system to the University Hospital Medical Information Network (UMIN) clinical research system using CDISC ODM, with the goal of improving clinical data quality using the CDISC standards. Yoshiteru has been teaching CDISC topics in the University of Tokyo School of Public Health (UT-SPH) since 2014.


Courses Taught:
Define-XML
ODM Implementation
SDTM Theory and Application

Training Languages:
Japanese
Conversant Languages:


Kunihito Ebi

Kunihito Ebi has been an IT Consultant at Fujitsu working for the pharmaceutical industry for the past 14 years. His main areas of expertise are clinical data standards, content management, regulatory submission, and compliance. Since the year 2000, Kunihito has also been Java/XML programmer and developed a free Define.xml generation tool. Kunihito Ebi has been a member of CDISC Japan User Group since 2013. He has been a product manager of CDISC-based metadata management system at Fujitsu since 2015.


Courses Taught:
Define-XML
ODM Implementation

Training Languages:
Japanese
Conversant Languages:


Julie Evans

Julie Evans is a senior systems analyst at Samvit Solutions, a health care consulting company focused on requirements analysis, systems modeling and data standards development. Julie has been involved with BRIDG since its inception in 2005 as a modeler and analyst, Semantic Coordination Committee (SCC) project leader, representative for CDISC’s semantic content, liaison to the BRIDG Board of Directors, project lead of the Adverse Event Domain Analysis Model and the CDISC Statistics Domain Analysis Model. She was also responsible for providing BRIDG content for CDISC’s SHARE Metadata Repository. Julie has 15 years of experience in biomedical standards development as well as 20 years of experience in software development and support. Prior to joining Samvit, she was the Senior Director, Technical Services for CDISC and worked in various roles in Information Systems for Shell Oil.


Courses Taught:
BRIDG Deep Dive
Introduction to BRIDG

Training Languages:
English
Conversant Languages:


Rhonda Facile

Rhonda Facile brings over 25 years of clinical development experience and has worked in a global CRO, as well as pharmaceutical and biotechnology companies in the United States and abroad. She has worked with CDISC for over eight years developing and contributing to the CDASH (CRF) standards program and the CDISC SHARE project. Ms. Facile currently manages the CFAST therapeutic area standards program as well as facilitating and ensuring that all CDISC standards projects progress and comply with CDISC development processes and policies. She holds a BA degree from the University of Texas at Austin and an MS in Organization Leadership and Ethics from St. Edwards University.


Courses Taught:
Unlocking a Global Language for Smarter Research

Training Languages:
English, Swedish
Conversant Languages:


Gitte 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).


Courses Taught:
SEND Implementation

Training Languages:
Danish, English
Conversant Languages:
French, Swedish

Nate Freimark

Nate is Vice President - Clinical Programming and Data Standards at The Griesser Group. Nate is the current CDISC ADaM team lead, a member of the CDISC TLC (Technical Leadership Committee), one of the ADaM trainers and a member of the SDS Oncology and Compliance subteams. Nate is also a co-lead of several PhUSE teams and is the ADaM lead for many CFAST Therapeutic Area User Guides (TAUGs). He has been a member of the ADaM team since 2005, a member of the ADaM Leadership Team since its creation, and has been “doing CDISC” since 2004. Nate has been involved in ADaM Education since its inception from the development of the training material to giving public, private, and FDA ADaM training courses.

 

Nate is also a lead programmer who has worked on numerous projects involving the creation of SDTM and ADaM datasets (and associated defines) as well as the tables, listings, and graphs created based upon them dating back to 2004. He works closely with other project team members within The Griesser Group and outside of The Griesser Group to produce a quality product on time. He has extensive experience with a broad range of therapeutic areas including anti-infective, oncology, and pain management studies.

 

Nate has also been a liaison between integrating companies trying to figure out how best to move forward in a unified CDISC compliant environment.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English
Conversant Languages:
Hebrew

Smita Hastak

Smita Hastak is co-founder and CEO of Samvit Solutions, a health care consulting company focused on requirements analysis, systems modeling and data standards development. Smita has been a modeler and an analyst on the Biomedical Research Integrated Domain Group (BRIDG) Model since the early days of this CDISC Domain Analysis Model. She is a member of BRIDG Semantic Coordination Committee (SCC) which is responsible for harmonizing the domain semantics from all BRIDG stakeholder’s initiatives into BRIDG for a common shared representation of the clinical research. Smita has more than 17 years of systems analysis and design experience in the health care domain. This includes over 12 years working in the cancer clinical research community on various analysis and software development projects and 5 years in state Medicaid and bio-surveillance software initiatives. She has served in many lead and senior roles at Unisys, Oracle and ScenPro over the past years.


Courses Taught:
BRIDG Deep Dive

Training Languages:
English
Conversant Languages:


Kit Howard

Kit Howard has over 30 years of experience in many facets of clinical research, including the development of data and process standards for exploratory through post-marketing clinical trials. She is the currently Director of Education for CDISC, both developing and presenting online and classroom training.  She is actively involved in data capture and regulatory submission data standards for drug, biologic and medical device research, and serves as co-leader of CDISC’s Medical Device Standards Development team.  She also serves on the CDASH Leadership team, the CDASH Governance Committee, and the SDTM Governance committee.

Kit is active in the professional community, speaking frequently at conferences, presenting standards and quality-related talks and webinars, and developing public health and clinical research informatics online courses for Michigan State University.  Previous to joining CDISC, Kit worked as Kestrel Consultants, where she guided research organizations in evaluating their data standards-readiness and in designing and implementing standards, specializing in "protocol through clinical study report" implementations that incorporated both process and CDISC standards.

 


Courses Taught:
CDASH Implementation
SDTM Theory and Application
SDTM Theory and Application for Medical Devices

Training Languages:
English
Conversant Languages:
Portuguese, Spanish

Sam Hume

Sam is Vice President of SHARE Technology and Services at CDISC. At CDISC he leads the SHARE project and co-leads the XML Technologies team. Sam has over 20 years of work experience in clinical research informatics. Previously, he worked as Director of IS Architecture at AstraZeneca, VP of Technical Operations at Phoenix Data Systems and Chief Technology Officer at CB Technologies. Sam has an MS in Information Science, MS in Telecommunications, and is completing his doctorate in Healthcare Informatics. 


Courses Taught:
Define-XML
ODM Implementation

Training Languages:
English
Conversant Languages:


Masaaki Imasho

Masaaki Imasho belongs to data management group of MSD K.K. and CDISC user group in Japan.


Courses Taught:
CDASH Implementation

Training Languages:
English, Japanese
Conversant Languages:


Monika Kawohl

Monika Kawohl is a Principal Statistical Programmer at HMS Analytical Software GmbH in Germany and has 23 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 contributed to the SDTM/ADaM pilot update, was involved with the ADaM validation and General Occurrences sub-teams and is currently the lead of the ADaM metadata sub-team. She is also a member of the executive committee of the German-speaking CDISC User Network.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English, German
Conversant Languages:


Kumiko Kimura

Kumiko Kimura is a senior statistical analyst at the CRO CMIC and has 10 years of experience in clinical statistical analysis. Her daily work includes project leading, creating SAP and mock-up shell, programming analysis datasets, creating define.xml and Analysis Data Reviewer’s Guide (ADRG) as well as consulting ADaM implementation within the company. Kumiko is also a member of CDISC Japan User Group (CJUG) since 2009 and expands the use of ADaM in Japan.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
Japanese
Conversant Languages:


Bron Kisler

Bron Kisler is a Co-Founder of CDISC and currently serves as Vice President, Strategic Initiatives. Within this role, he is responsible for identifying new growth opportunities for CDISC, steering the organization into new clinical and geographic markets, and managing key strategic alliances. Bron has 25-years of technical and business experience from both the public and private sectors, and has worked in the pharmaceutical industry for 15-years, developing innovative clinical research solutions. He spearheaded the CDISC Terminology Program in 2005, and has been successful in launching CDISC Therapeutic Area projects. Bron is currently Chair of the Joint Initiative Council for global standards harmonization and serves on the BRIDG Board of Directors. He is a graduate of the University of Central Florida and holds 3 Bachelor of Science degrees in Mathematics, Computer Science and Statistics.


Courses Taught:
Controlled Terminology Implementation
Unlocking a Global Language for Smarter Research

Training Languages:
English
Conversant Languages:


Karlien Knevels

Karlien Knevels is a BSc in Applied Computer Science and works as Senior Clinical Data Programmer Coordinator  at SGS Life Science Services.  In this role she is mainly responsible for overviewing the whole DM process from programmers side: streaming conversions from source data to CDISC SDTM standards, building of checks for review of the data, building Define-XML for submission purpose, and coordinating programming activities.


Courses Taught:
Define-XML

Training Languages:
Dutch, English
Conversant Languages:
French

Shannon Labout

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.


Courses Taught:
CDASH Implementation
SDTM Theory and Application
Unlocking a Global Language for Smarter Research

Training Languages:
English
Conversant Languages:


Sarah McLaughlin

Sarah McLaughlin has 25+ years experience in health research as a SAS progammer and data standards expert.  She is knowledgeable about CDASH, SDTM, controlled terminology and ADaM.  She has volunteered on the CDASH and Diabetes TAUG teams. Sarah has an MPH in Epidemiology.

 

Sarah is highly proficient in clinical research, from development of CRFs, through clinical database design, SDTM mapping, creation of analysis files, production of tables, listings, figures to submission to regulatory authorities.   She has experience in phase I-III clinical trials, healthcare utilization and epidemiological studies. Sarah’s therapeutic experience includes neurology, infectious diseases, substance abuse disorders, maternal/fetal health, and immunology. 


Courses Taught:
SDTM Theory and Application

Training Languages:
English
Conversant Languages:


Sandra Minjoe

Sandra is a Senior ADaM Consultant at Accenture Life Sciences, helping clients implement ADaM. She is part of the ADaM Leadership Team (ALT) and reviews draft ADaM documents with a focus on the fundamental principle of traceability. Recently Sandra led the ADaM sub-team for the Occurrence Data Structure (OCCDS) and co-led the finalization of ADaMIG v1.1. An active ADaM team member since 2001, she proposed structures that later became ADSL and OCCDS. In addition to her ADaM work, Sandra co-led the Computational Sciences Symposium work group on Transparency and Data Flow, helps coordinate the Bay Area (San Francisco) CDISC Implementation Network meetings, and is an Executive Committee member for PharmaSUG. Sandra has worked in the pharma/biotech industry since 1993, at both sponsor and vendor organizations, in a variety of roles, including programmer, statistician, data manager, and filing team lead.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English
Conversant Languages:


Erin Muhlbradt

Dr. Erin Muhlbradt is a contractor for the National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) and is the NCI EVS project lead for the Clinical Data Interchange Standards Consortium (CDISC) terminologies. Erin has over 5 years’ experience in the bioinformatics and pharmaceutical industries, including data standardization, database and metadata repository development, and terminology development. She manages a team at EVS that is responsible for the development and maintenance of CDISC controlled vocabularies in use by the pharmaceutical industry and the US Food and Drug Administration (FDA). Her duties include project management, biomedical and clinical trial subject matter expertise, terminology development, quarterly terminology publications, managing the CDISC terminology change request mechanism, and developing the content around the CDISC metadata repository. Previously, Erin was a doctoral candidate at Georgetown University in the Tumor Biology department and she performed her thesis work in laboratories at Georgetown University and Columbia University.

 

Erin holds a Bachelor of Science Degree (Honors) in Molecular and Cellular Biology from the University of Glasgow (Glasgow, Scotland) and a Doctoral Degree in Tumor Biology from Georgetown University (Washington DC).

 

Erin is active on all CDISC controlled terminology teams, a member of the management team for the CDISC SHARE project and active on therapeutic area standards development teams.


Courses Taught:
Controlled Terminology Implementation

Training Languages:
English
Conversant Languages:


Barrie Nelson

Barrie Nelson works with CDISC leadership and volunteer teams to guide the future of standard development. He has over 18 years’ experience in biostatistical programming and clinical data management, managing and implementing data standards functions, and leading a governance body to oversee the use of standards. Working for such CDISC member organizations as GSK, Amgen and Onyx, Mr. Nelson led and contributed to many process improvement initiatives where standards were at the heart of these projects, with specific goals of cycle-time reduction, reduced operational costs and increased quality. He has been a volunteer and leader for CDISC teams since 2003, and spearheaded the development of the Oncology domains for SDTM.


Courses Taught:
Controlled Terminology Implementation
Unlocking a Global Language for Smarter Research

Training Languages:
English
Conversant Languages:


Jon Roth

With over 25 years in this industry, Jon is a highly experienced consultant in pharmaceutical drug development life-cycle projects. He has been a member of the ADaM team since 2006, and since that time, most of his consultant work has focused on CDISC ADaM implementations in support of statistical programming, study integration and regulatory filing activities. Of note, he was the first authorized CDISC ADaM trainer within Europe and was responsible for the analysis data and reporting of the industry's first ADaM compliant regulatory submission to the FDA. In later years, he has been instrumental in numerous regulatory data filings with the FDA and European authorities on projects involving Lundbeck, Takeda, Forest Labs, Novo Nordisk, Merck, Abbott, Solvay, Wyeth, Novartis, and Sandoz.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English, Italian
Conversant Languages:


Jerry Salyers

Jerry joined Octagon Research Solutions (now part of Accenture Life Sciences) Data Standards Consulting group in January 2009 after 15 years in clinical data management at Procter and Gamble Pharmaceuticals.  During his time with P&G, Jerry was involved in getting several new drugs and indications through the clinical-trial process and ultimate submission.  He presented at numerous investigator meetings across the US and throughout Europe.  With P&G, he was also active within the industry, representing P&G at the e-Clinical Forum (in both the US and Europe), where he presented a number of papers on electronic data capture and data warehousing.

 

With Accenture, Jerry provides an internal consulting resource to the Data Standards and Integration department as well as the in-house data management group.  He also works one-on-one directly with several sponsors in review of mapping specifications (via CRFs and datasets) from source to SDTM-based datasets.


Courses Taught:
CDASH Implementation
SDTM Theory and Application

Training Languages:
English
Conversant Languages:


Taku Shimizu

Taku Shimizu is currently an analyst at Quintiles Transnational Japan K.K. He has been a SDTM specialist for 5 years with practical experience of SDTM development (40+ protocols) and implementation with multiple pharmaceutical companies.

 

He has managed all aspects of the SDTM, recently with define.xml, development and operation processes (schedules, designs, productions, tests, releases, editorials and maintenances) with efficiency. His skills are SAS, Pinnacle 21, and coordinating Data Manager and Biostatistician peacefully in a view of SDTM Specialist.

 

Taku joined LAB team in 2006. Since 2009, he has been an active member on the SDTM team. He earned a B.S. in Biochemistry from the Kyoto Institute of Technology.


Courses Taught:
SDTM Theory and Application

Training Languages:
Japanese
Conversant Languages:
English

Lauren Shinaberry

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. Lauren is the 2012 Chair of the CDISC Advisory Board and is part of the CDASH Leadership Team.

 

 

 

 


Courses Taught:
CDASH Implementation
SDTM Theory and Application

Training Languages:
English
Conversant Languages:


Jack Shostak

Jack Shostak manages a group of statistical programmers and is an Associate Director of Statistics at the Duke Clinical Research Institute.  He is the author of SAS Programming in the Pharmaceutical Industry and coauthor of Common Statistical Methods for Clinical Research with SAS Examples, Third Edition as well as Implementing CDISC Using SAS: An End-to-End Guide, Second Edition. Jack has been active in CDISC since 2002 primarily as a contributor to ADaM model development.  Jack serves as a member of the ADaM leadership team and has been a CDISC ADaM instructor for industry and the FDA for the past decade.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English
Conversant Languages:


Dana Soloff

Dana Soloff is the owner of Mandira Consulting LLC, a company specializing in helping Pharmaceutical companies define and integrate CDISC standards into how they do business across the development lifecycle, efficiently and pragmatically. Dana is a long-time member of the CDISC ADaM team and is currently supporting the ADaM Integration and Education sub-teams.   Before forming Mandira Consulting, Dana spent 20 years in the Health Care and Pharmaceutical Industries in Statistical Programming, Healthcare Data Systems Outsourcing, Clinical Data Standards Governance, and MDR implementation. 


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English
Conversant Languages:


Satoshi Ueno

Satoshi Ueno is an assistant professor in the Faculty of Medicine at the University of Tsukuba. He has been involved in clinical research as a data manager and clinical research associate since 2004 and carried out basic research in molecular biology and biochemistry since 2006. Satoshi has worked in academia, national institutes, and a global contract research organization in Japan. He holds a masters degree and a doctoral degree in biological science from the University of Tsukuba. Satoshi is a member of the CDASH and SDS teams of the CDISC Japan User Group (CJUG). He promotes the application of Clinical Data Acquisition Standards Harmonization (CDASH) of CDISC to define data items in case report forms (CRF).


Courses Taught:
CDASH Implementation

Training Languages:
Japanese
Conversant Languages:


Johannes Ulander

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.


Courses Taught:
SDTM Theory and Application

Training Languages:
English, Swedish
Conversant Languages:
Danish

Peter van Reusel

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.

 


Courses Taught:
CDASH Implementation
SDTM Theory and Application
Unlocking a Global Language for Smarter Research

Training Languages:
English
Conversant Languages:
Dutch, French, German

Wendy ver Hoef

Wendy Ver Hoef is a senior systems analyst at Samvit Solutions, a health care consulting company focused on requirements analysis, systems modeling and data standards development. Wendy has been a modeler and an analyst on the Biomedical Research Integrated Domain Group (BRIDG) Model since 2007 and is a member of BRIDG Semantic Coordination Committee (SCC). She has participated in the harmonization of several CDISC standards into BRIDG and lead the harmonization efforts for numerous other BRIDG contributors. Wendy has more than 10 years of systems analysis and design experience in the health care domain, predominantly in the cancer clinical research community, but also in pharma initiatives. In her earlier career, she gained analysis, design and programming experience in other industries such as DoD and video-on-demand. Prior to joining Samvit, she worked in the consulting division at Oracle for 14 years and for the last 8 years was a Senior Analyst at ScenPro, Inc.


Courses Taught:
BRIDG Deep Dive

Training Languages:
English
Conversant Languages:


Gary Walker

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.


Courses Taught:
CDASH Implementation
SDTM Theory and Application

Training Languages:
English
Conversant Languages:


Aimee Wang

Aimee Wang is senior project manager in clinical trial data management at MSD R&D (China) Co. Ltd. Aimee has been working in pharma industry for more than 9 years. She is very experienced on project management of clinical trial data management and very strong E2E data management knowledge for various therapeutic areas, including CRF design, database programming/testing, data cleaning, DBL and reporting, etc.


Courses Taught:
CDASH Implementation

Training Languages:
Chinese
Conversant Languages:
English

John Wang

John Wang is Senior Manager of SAS Programming. He has 10+ years extensive statistical analysis experience in all phases of clinical trials, familiar with different kinds of programming languages and system tools in clinical research. Before he joined dMed, he was Manager of SAS Programming in J&J China since 2009. Prior to that, he was associate manager of SAS programming for four years at Global Research Services, LLC. He is Vice Chair and team lead for the SDTM group in C3C (China CDISC Coordinating Committee). He has very extensive experience using CDISC fundamental data standards such as CDASH, SDTM, ADaM, Controlled Terminology and define.xml. He became CDISC authorized SDTM Instructor in early 2016.


Courses Taught:
SDTM Theory and Application

Training Languages:
Chinese
Conversant Languages:
English

Zhijun Wei

Stanley Wei is Group Head of Cardio-Metabolism Franchise in Statistical Reporting at Novartis Pharmaceutical. He is also currently undertaking a role in tools development in the Technology Standards and Processes group.

Stanley graduated from School of Pharmacy, Fudan University in 2006, with a Master’s degree in pharmacology and has more than 10 years of industrial experience in data manipulation, reporting and analysis, including 6+ years of CDISC standards implementation with clinical trial data (SDTM, ADaM and Define.XML) and 4 years of analysis with real-world observational databases (including US claims database, UK GPRD, IMS database, etc.). Prior to joining Novartis, Stanley also worked in PPD and Medifacts International for about 4 years as a programming manager.

Stanley is also one of the core and initial C3C (China CDISC Coordinating Committee) members, and has been responsible for the coordination of the CDISC China authorized trainer program, public training events, and is also the webmaster of the C3C official website for multiple years. In addition, he also coordinated and participated in the review process of the translated Chinese version of CDISC standards.


Courses Taught:
SDTM Theory and Application

Training Languages:
Chinese
Conversant Languages:
English

Mario Widel

Mario Widel is a Research Scientist at Eli Lilly and Company.  He has been doing statistical programming since 1992. 

 

He has been involved in CDISC related activities since 2007 on a previous company having a key role in the transition to CDISC standards CDASH, SDTM and ADaM.  In his current role Mario oversees and participates in the metadata definition for SDTM and ADaM datasets, the design, creation and validation of TFL’s. 

 

He received his M.S. degree on Computer Science from the University of Illinois at Chicago. He is a regular presenter at conferences like JSM, PharmaSUG,  SAS Global Forum, PhUSE and CDISC and a member of ASA and the CDISC ADaM team.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
English, Spanish
Conversant Languages:


Fred Wood

Fred is Senior Manager and Lead of the Data Standards Consulting Group within Accelerated R&D Services, a group he has led since 2007. He has been active in leading the development of CDISC standards since 1999. He is one of the principal contributors to the CDISC Study Data Tabulation Model (SDTM). Fred is a founding member of the SDS Team (1999), the SEND Team (2002), and the Devices Team (2007), and has led or co-led these for many years; he currently serves on the Leadership Teams of all three. Fred is currently a member of the CDISC Standards Review Council (SRC), the CDISC SDTM Governance Committee (SGC), and the CDISC Technical Leadership Committee (TLC). He has been a member of many other CDISC SDTM-related teams since 1999, and is providing SDTM expertise to therapeutic-area projects conducted as part of the CFAST initiative.

Fred joined Accenture via the Octagon acquisition in 2012. He joined Octagon in 2006, coming from Procter & Gamble Pharmaceuticals, where he was the Global Data Standards Manager in the Clinical Data Management Department. This position was preceded by many years as a Senior Toxicologist at P&G, supporting Rx and OTC products. Fred has a Ph.D. and an M.S. in Biochemistry from the University of Massachusetts in Amherst, and a B.S. in Biology from Springfield College in Springfield, Massachusetts.


Courses Taught:
SEND Implementation

Training Languages:
English
Conversant Languages:


Chongsheng (Victor) Wu

Victor Wu, Ph.D., is Co-founder of Beijing Data Science Express Consulting Co., Ltd. Dr. Wu has over 10 years of work experience in biometrics and 8 years of experience on CDISC standards implementation (including CDASH, SDTM and ADaM). He is highly proficient in clinical study, from protocol/statistical design, CRF development, SDTM mapping, programming for analysis datasets and tables, listings, figures to submission package. Victor is also experienced in process optimization. Victor has contributed to the review of the Chinese version of CDISC standards documents and has coordinated CDISC activities in China as vice chair & chair of C3C.


Courses Taught:
SDTM Theory and Application

Training Languages:
Chinese
Conversant Languages:
English

Hiromi Yamamoto

Hiromi Yamamoto is a reviewer of Advanced Review with Electronic Data Promotion Group at Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is a Certified Clinical Data Manager (CCDM) from the Society for Clinical Data Management (SCDM), and she has 12 years of data management experience at Eli Lilly. She is highly competent in all aspects of data management, across all phases of clinical trial research and in many therapeutic areas. Prior to this, she worked in clinical research operations at Eli Lilly, is a licensed pharmacist in Japan, and holds a Master degree in Pharmacy from Kyushu University and MBA. She will provide CDISC licensed training within PMDA only.


Courses Taught:
SDTM Theory and Application

Training Languages:
Japanese
Conversant Languages:
English

Seiko Yamazaki

Seiko Yamazaki is a statistical analyst and a programmer at CMIC. Seiko obtained her master’s degrees in applied statistics and clinical psychology. She has been working on projects that require compliance with the CDISC standards. She is also active in implementing the ADaM standard in her role at CMIC. Her current job responsibilities include creating statistical analysis plans/mock-up plans, specs for analysis datasets, and creating tables, figures and listings.


Courses Taught:
ADaM Primer
ADaM Theory and Application

Training Languages:
Japanese
Conversant Languages:
English

Lily Zhao

Lily Zhao is Associate Director of Global Data Operations at PAREXEL. Lily holds a medical degree, and has been in the clinical research industry for 13 years after her 3-year career as a physician. She has rich project experience for both data management and project leadership in various therapeutic areas and has been using CDASH for CRF design and Dataset setup since 2008. She is actively involved in the CDISC standard-relevant activities in China, which include user group meetings, trainings, and CDASH standard translations. Lily formally became a member of C3C (China CDISC Coordinating Committee) in 2014.


Courses Taught:
CDASH Implementation

Training Languages:
Chinese
Conversant Languages:
English