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.
Nancy Brucken
Nancy Brucken is a Senior Standards Engineer on the Data Standards team at IQVIA, responsible for ADaM implementation, compliance and internal tool development. She has been an ADaM team member since 2011, a contributor to the OCCDS v1.0, Rheumatoid Arthritis Therapeutic Area, ADaM IG v1.2, ADaM COVID-19 guidance, ADaM Metadata Submission Guidelines and Traceability sub-teams, serves as co-leader of the ADQRS sub-team, and received a CDISC award for Outstanding Contributions to Standards Development in 2017. Nancy has been a frequent presenter and seminar/workshop instructor on ADaM-related topics at various industry conferences.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application, CDISC for NewcomersTraining Language(s):
EnglishConversant Language(s):
EnglishNate Freimark
Nate Freimark is Vice President - Clinical Programming and Data Standards at The Griesser Group. He served as ADaM team lead from 2010-2017, and is a member of the CDISC GGG (Global Governance Group), SDS Oncology, QS and Compliance sub-teams. Nate is also a member of several PHUSE teams (working on improving data quality and site selection standards) and the ADaM lead on the development for many 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.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
HebrewMarcelina Hungria
Marcelina Hungria is an owner of DIcore Group, a CDISC Gold Member. As a consultant, supports clients with Metadata Repository (MDR) development, CDISC Standards Implementation and Data Submission services.
She has a BS in Computer Science and an MBA from Rutgers University. She has extensive experience developing and validating software tools, plus overall system testing. Expertise in SAS and other programming languages.
Marcelina has been working in the pharma/biotech industry for nearly 30 years, and for the last 20 has been focusing on preparation of SDTM and ADaM-based data and results, plus validation of regulatory submissions and metadata management systems in connection with implementation of most CDISC Standards. Overall, helping sponsors to plan, collect, integrate, validate and improve the quality of data for multiple uses, building software tools to provide traceability and impact analysis from planning to analysis results. She has been involved in the development and testing of the CDISC Library metadata, contributing to curate content for CDASH, SDTM and Controlled Terminology, and performing API testing.
Marcelina has been a CDISC volunteer since 2008, active participant on the CDISC Data-Exchange (former CDISC XML Technologies), SDTM and SDTMIG development teams, core team member in the ODM 2.1, Define-XML 2.x, Dataset-JSON 1.x Standards, plus diverse SDTM and SDTMIG versions and the MSG 2.0 development efforts, and more recently active contributor on the CDISC CORE initiative. She is also contributing on the CDISC ODM Certification Program.
Previous contributions to PhUSE/FDA WG's include deliverables related to Metadata, Traceability and Analysis Results projects plus the Define-XML 2.0 / Implementation Guidelines.
Course(s) Taught:
CDISC for Newcomers, CDISC Open Rules Hands-on Implementation Training, Dataset-JSON Hands-on Implementation , Define-XML, ODM ImplementationTraining Language(s):
English, SpanishConversant Language(s):
English, SpanishErin Muhlbradt
Dr. Erin Muhlbradt is a contractor for the US National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) and is the NCI EVS and CDISC project lead for CDISC terminology development. Dr. Muhlbradt has over 15 years’ experience in the bioinformatics and pharmaceutical industries, with skills including terminology development, data standards development, database and metadata repository development, and data modeling.
She manages a team at EVS that is responsible for the development, publication, and maintenance of CDISC controlled vocabularies in use by the pharmaceutical industry and mandated by the US Food and Drug Administration (FDA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Her duties include project management, biomedical and clinical subject matter expertise, terminology development, biannual terminology publications, and management of the CDISC terminology change request mechanism.
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 leads, co-leads, or oversees 19 active CDISC controlled terminology teams. She is a co-lead of the SDS Genomics subteam, a co-lead of the SDS Cell Phenotyping sub-team, a co-lead of the SDS Lab team, a voting member of the CDISC Global Governance Group (GGG), and a terminology representative on many therapeutic area standards development teams.
Course(s) Taught:
Controlled Terminology, Controlled Terminology AdvancedTraining Language(s):
EnglishConversant Language(s):
EnglishLisa Mulcahy
Lisa Mulcahy has an extensive career in the biopharmaceutical industry in the areas of Clinical Operations, Quality Management, and TMF Management. She became an independent consultant 16 years ago, tying previous work experiences together to assist clients to develop, revise, and operationalize high-quality and compliant TMF management processes to achieve complete and inspection-ready of TMFs. Her consultancy allows her the pleasure to work with clients, very small biotechs to large pharmaceutical companies, in many different ways, such as selection, implementation, and expanded use of eTMF systems, training and/or leading TMF management resources, performing quality and completeness reviews of study-specific TMFs, and performing a company’s TMF management assessments for clients so they can establish and/or improve processes to become more compliance and inspection ready. Each of her projects with the focused intent to achieve compliant, complete, and inspection-ready TMFs. Lisa is a co-founder and a current Steering Committee member of the CDISC TMF Reference Model volunteer team of industry representatives that created and maintain the model.
Course(s) Taught:
Fundamentals of the TMF Reference Model, The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF ExcellenceTraining Language(s):
EnglishConversant Language(s):
EnglishDawn Niccum
With over 30 years of Clinical Operations, Clinical Systems and Quality Assurance pharmaceutical experience, Dawn provides our clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance and auditing, inspection readiness activities, SOP development, computer system validation, quality document management, training, and safety. Her extensive experience and strength in establishing quality structures and streamlined approaches to reduce risk remains a tremendous asset in inSeption’s ability to deliver outstanding quality, best practices, efficient systems, and cost savings to our sponsors. Additionally, Dawn is recognized for her expertise in implementing TMFs across settings and systems, is a member of the CDISC TMF Reference Model Group Steering Committee and Chair of the Education Committee, is an active member of the Society of Quality Assurance and has presented as a Subject Matter Expert at numerous conferences.
Course(s) Taught:
Fundamentals of the TMF Reference Model, The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF ExcellenceTraining Language(s):
EnglishConversant Language(s):
EnglishJerry Salyers
Jerry is currently SDTM and CDASH Implementation Advisor for Data Standards Consulting, a Talent Mine Group. Jerry previously worked for the Accenture Life Sciences Data Standards Consulting group starting 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 provided internal consulting resources to the Data Standards and Integration department as well as the in-house data management group. He also worked one-on-one directly with several sponsors in review of mapping specifications (via CRFs and datasets) from source to SDTM-based datasets.
Course(s) Taught:
CDASH Fundamentals, Private Training - CDISC Open Rules Hands-On Implementation Workshop for TIGTraining Language(s):
EnglishConversant Language(s):
Jack Shostak
Jack Shostak is the Director of Biostatistical Operations 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 has been a CDISC ADaM instructor for industry and the FDA for the past decade.
Course(s) Taught:
ADaM Core Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
Jenn Stamper
With 20 years of experience in managing the Trial Master File (TMF), Jenn specializes in TMF oversight and inspection activities, providing clients with valuable guidance and expertise. She began her career with a Contract Research Organization (CRO) in the traditional paper format and has witnessed the evolution of electronic TMF (eTMF), including advancements in processes and regulations. Recognizing that clients are at different stages in their eTMF/TMF journey, Jenn is dedicated to helping them achieve a quality TMF that is compliant with Good Clinical Practice (GCP), complete, and ready for inspection. As a Director at Just in Time GCP, she leads the Services department, sharing her passion for the TMF through training and mentoring others in conducting record quality checks, quality and completeness reviews, high-risk assessments, and inspection readiness activities both within the TMF and on-site. Jenn is a core member of the CDISC Education Committee and actively participates in CDISC TMF Reference Model groups as a volunteer. She also presents at various industry events, sharing her insights and knowledge.
Course(s) Taught:
Fundamentals of the TMF Reference Model, The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF ExcellenceTraining Language(s):
EnglishConversant Language(s):
EnglishGary 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 Library. Prior to leaving Quintiles (now IQVIA), Gary worked within the Innovation group which was focused on new and innovative products, and was part of a team focused on EHR data use for clinical research.
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):
EnglishConversant Language(s):
Richann Watson
Richann Watson is an independent statistical programmer and CDISC consultant with over 25 years’ experience working in the pharmaceutical industry. She is a member of the ADaM team. She contributed to ADaMIG v1.2 as well as the ADaM Oncology and ADaM Traceability supporting documents. In addition, Richann is a member of the ADaM v3.0 sub-team. She is an Executive Committee member for PharmaSUG and WUSS. Richann has presented several papers and seminars on ADaM-related topics at various conferences.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
EnglishMario Widel
Mario Widel is an independent statistical programmer and CDISC consultant. He has been doing statistical programming since 1992 and has been involved in CDISC related activities since 2007 having a key role in the transition to CDISC standards CDASH, SDTM and ADaM. Currently, Mario develops and maintains submission deliverables including SDTM and ADaM design, development and testing.
He received his M.S. degree in Computer Science from the University of Illinois at Chicago. He is a member the CDISC of ADaM team and a regular presenter at conferences including JSM, PharmaSUG, SAS Global Forum, PhUSE and CDISC Interchange.