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.
Nancy Brucken is a Standards Engineer in the Data Standards and Innovations group at Syneos Health, 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 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.
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.
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.
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.
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.
Sam Hume leads the CDISC Data Science team, which collaborates with CDISC staff and stakeholders to develop tools and standards that support clinical and translational data science. Dr. Hume directs delivery of the CDISC SHARE metadata repository that houses all CDISC standards, co-leads the CDISC Data Exchange Standards team, and leads the CDISC RWD efforts. He holds a doctorate in information systems.
Kristin Kelly is an Associate Director at Pinnacle 21 in the Clinical Data Standards group. Kristin has over 10 years of experience working in the pharmaceutical industry primarily focused on clinical data standards. Prior to joining Pinnacle, Kristin was an Associate Director at Merck in the Global Clinical Data Standards (GCDS) group. She was also worked a consultant in Data Standards Consulting (DSC) for Accenture (formerly Octagon Research Solutions). She provides guidance on CDASH and SDTM standards to both internal project teams and external clients. Kristin is also involved with the CDISC SDS team, CFAST Initiative TAUG teams, SEND Core Team, as well as several PhUSE CSS Working Groups. Kristin has led several SDTM conversion projects for submission to both CDER and CBER that have resulted in FDA approvals. Kristin holds a B.S. in Biology from Saint Joseph’s University.
Shannon Labout is a Certified Clinical Data Manager (CCDM®) with more than two decades of experience implementing and managing healthcare and research technologies and data, providing team and organizational leadership, and developing and delivering best practices in clinical data management and standards implementation for industry, regulators and academia in multiple therapeutic areas of drug and medical device research.
Since 2007, Shannon has been an Authorized CDISC Instructor, and has been deeply involved in developing online and classroom courses for CDASH, SDTM, and other CDISC topics for industry, regulators and academic researchers.
Shannon is currently the owner and principal of Data Science Solutions LLC, a consultancy helping organizations implement best practices and data standards into their workflow and culture. She has served on the Board of Trustees for the Society of Clinical Data Management (SCDM) since 2014 and is the 2018 SCDM Board Chair.
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.
Sandra is a Senior Principal Clinical Data Standards Consultant at PRA Health Sciences, helping implement ADaM. She is the ADaM Team Lead, part of the ADaM Leadership Team (ALT) and reviews draft ADaM documents with a focus on the fundamental principle of traceability. Previously, Sandra led the ADaM sub-team for the Occurrence Data Structure (OCCDS) v1.0 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. 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.
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.
Barrie 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.
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.
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.
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.
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.
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.
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.
Richann Watson is an independent statistical programmer and CDISC consultant with over 20 years’ experience working in the pharma industry. She is a member of the ADaM team and is currently the co-lead of the ADaM Oncology sub-team. In addition, Richann is a member of the ADaM IG1.2 and the ADaM Traceability sub-teams. She is an Executive Committee member for PharmaSUG and is the chairperson for the local SAS user group in the Cincinnati/Northern Kentucky area and is actively involved with SAS Global Forum and other SAS User Groups.
Mario Widel is a Principal Statistical Programmer at Covance. 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 reviews submission deliverables including aCRF, SDTM, ADaM and define.xml.
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.
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.