Kevin Burges
Head of Product Management
Formedix
August 2023 Volunteer Spotlight
We are excited to spotlight Kevin Burges and to recognize more than 20 years of volunteering with CDISC!
Kevin has long been a leader in the development of ODM, and he contributed significantly to the recently released ODM v2.0 standard. His extensive knowledge of ODM stems from his long tenure as a key member of the CDISC Data Exchange Standards team, as well as his experience developing solutions using ODM. Kevin has a keen eye for detail, deep technical knowledge, and a collaborative style that make him invaluable to the team.
David Neubauer
Standards Engineer
IQVIA
July 2023 Volunteer Spotlight
With a strong knowledge of SDTM, David began volunteering for CDISC over 6 years ago after implementing the standards for many years. David's leadership and domain knowledge are essential in driving the standards forward, making him an invaluable asset to many workstreams, such as SDS and CORE.
He is the co-lead of the SDS SUPPtoNSV team and actively contributes to various CDISC teams, including SDS, the SDS Oncology subteam, and CORE.
Akira Soma
Solution Director
Oracle Japan
June 2023 Volunteer Spotlight
Akira serves as Chair of the CDISC Japan Coordinating Committee (J3C), managing a variety of initiatives and overseeing such activities as the upcoming 2023 CDISC Japan Interchange. An SDTM expert, he has been involved with the CDISC Japan User Group SDTM team for over 10 years and is an authorized instructor in SDTM Theory and Application. Under Akira’s leadership, the J3C is coordinating a workshop in November to encourage the use of CDISC Standards in academia.
Nancy Brucken
Senior Standard Engineer
IQVIA
May 2023 Volunteer Spotlight
Nancy embodies the true spirit of collaboration. Congenial, with vast knowledge of ADaM, she has served as a key contributor on the development of a number of standard releases including: ADaM OCCDS v1.0, Rheumatoid Arthritis Therapeutic Area User Guide, ADaMIG v1.2, ADaM COVID-19 Guidance, ADaM Metadata Submission Guidelines v1.0.
Nancy also co-leads the ADQRS sub-team who develop ADaMIG QRS Supplements. A CDISC-authorized instructor, she shares her expertise teaching ADaM Advanced, ADaM Core Theory and Application, and CDISC for Newcomers.
Jozef Aerts
Owner
XML4Pharma
April 2023 Volunteer Spotlight
Innovative, insightful, technical, and reliable are what come to mind when describing Jozef who has devoted over 20 years of his time and expertise volunteering at CDISC. He serves on the ODM and Define-XML teams and is a key contributor to CORE, a project he considers to be a revolution. Jozef keeps team meetings entertaining with his amazing sense of humor. A CDISC-authorized instructor, his Spotlight, like other Volunteer Spotlights, features helpful tips about working with CDISC Standards.
Kelley Robinson
Head of TMF Operations
Sention Therapeutics
March 2023 Spotlight
Kelley just stepped down from serving as Chair of the Change Control Board, a role she led for five years. A bridge builder and full of personality, she promoted an inclusive working environment that enabled the team to work together successfully. She brings this skill set and enthusiasm to her new role, volunteering and leading a sub-group on the TMF Standards Team who are positioning the TMF Reference Model to become a CDISC Standard.
Nicholas Pemble
Head of Data Collection Standards
The Janssen Pharmaceutical Companies of Johnson & Johnson
February 2023 Spotlight
Sharp with a self-effacing sense of humor, Nik is one of the beating hearts of the CDISC Controlled Terminology Team. He co-leads the SDS Lab sub-team who maintain the LB and MI domains and develop the supporting Controlled Terminology.
Nik began volunteering at CDISC because he believes developing standards for clinical research to be the most important development in clinical data management since the birth of modern computing.
Diane Corey
Senior Data Manager and Standards Developer
The Critical Path Institute
January 2023 Spotlight
Patient well-being and quality of life are very important to Diane. As a result, she found her volunteer calling developing standards for Questions, Ratings and Scales (QRS) instruments. Diane co-leads the QRS-SDS Team who develop supplements to the SDTMIG for public domain and copyright-approved instruments. A long-standing, key contributor to the development of CDISC QRS supplements, she feels that QRS instruments can play a key role in assessing a patient’s day-to-day life.
Marcelina Hungria
Owner
DIcore Group
A combination of technical expertise and strong standards knowledge distinguish Marcelina's volunteerism at CDISC. Over the years, she has contributed her insights to the development of Data Exchange and Foundational standards, including Define-XML, Dataset-XML, ODM v2.0, SDTM and SDTMIG. Conformance testing and validation are always top of mind with Marcelina as she shares input and feedback to develop standards attuned to the practicalities of their implementation. Affable and detail-oriented, she's also an authorized-CDISC Instructor.
Melissa Binz
Vice President, Data Sciences Institute
Takeda
November 2022 Spotlight
For two decades, Melissa has been serving the research community by volunteering at CDISC. She brings a unique combination of extreme knowledge and effervescence in leading the CDASH team. In fact, we refer to her as the team’s “Fearless Leader” with her keen ability to stay on top of everything while keeping the work fun and engaging with her spirited sense of humor.
Soumya Rajesh
Sr. Standards Engineer, Global Data Standards
IQVIA
October 2022 Volunteer Spotlight
Soumya is a go-getter. She’s a key contributor to many teams: Future lead of the Submissions Data Standards (SDS) team who work on the SDTMIG, co-leads SUPP to NSV sub-team, and recently joined the CDASH team to contribute her insights to the development of CDASHIG v2.3. Soumya is also in the process of becoming a CDISC-authorized instructor to teach SDTM Theory and Application AND currently writing an article on Clinical Classifications for the CDISC Knowledge Base.
Steve Fitzpatrick
Technical Expert, Biometrics
Novartis
September 2022 Volunteer Spotlight
Steve has volunteered on the CORE Team since its inception. Knowledgeable, dedicated and undaunted, he understands how important CORE is for Industry and has taken on writing some of the more complex rules with aplomb. His service has made a huge impact on the CORE project.
Brian Harris
Standards Developer Senior Director, Clinical Data Standards
AstraZeneca
August 2022 Volunteer Spotlight
Brian leads the team who develop ADaM, CDISC’s standard for analysis, which is required for data submission to US FDA and Japan PMDA. Brian’s positive and optimistic leadership style has successfully guided the team through the releases of ADaMIG v1.2 and ADaMIG v1.3.
Ben Sefing
Principal Scientist, Nonclinical Drug Safety
MERCK
July 2022 Volunteer Spotlight
Ben leads the SEND team who develops standards for nonclinical data. SEND is one of the required standards for data submission to FDA. Ben’s years of experience working with pathology data, combined with his ability to represent sponsor organizations who partner with CROs, technology service providers, and regulatory authorities, contribute an essential perspective to the team’s current objectives. The SEND team is well-positioned to meet challenges and deliver solutions under Ben’s leadership.
Varma Nadimpalli
Principal Statistical Programmer
PHASTAR
June 2022 Volunteer Spotlight
Varma co-leads the eCRF Portal Team, which develops CDASH-compliant, annotated case report forms for the CDISC eCRF Portal. An expert in infectious diseases, he brings both public health and clinical research to his volunteer role at CDISC. Varma actively contributes his expertise to a variety of our standards development teams.
Erica Gonzales
Senior Principal Clinical Data Standards Consultant, Global Data Standards - Biometrics
ICON
June 2022 Volunteer Spotlight
Erica co-leads the eCRF Portal Team, which develops CDASH-compliant, annotated case report forms for the CDISC eCRF Portal. Passionate about eCRF design, Erica understands the critical importance of incorporating standards into the development of case report forms. She enjoys collaborating with industry peers to ensure the best eCRF design choices are made.
Melanie Paules
Director, Statistical Programming
Takeda
May 2022 Volunteer Spotlight
Melanie faithfully leads the SDS Oncology Sub-team, which defines new standards and supports existing SDTM standards for oncology studies. She brings a deep subject matter knowledge of the oncology space to her role, with a foresight to understand future needs of the user community.
Els Janssens
Executive Manager Secure Data Office
SGS Health Science
April 2022 Volunteer Spotlight
New to volunteering at CDISC, Els readily stepped in and took on the challenge of developing and QCing many machine-executable rules for CORE, which was launched at the CDISC Virtual Europe Interchange. Passionate about using standards from the start, she presented “Embracing the SDTM Mindset at Study Start to Mitigate Compliance Issues” at the Interchange.
Marc Ellison
Instem
Director, SEND Solutions
March 2022 Volunteer Spotlight
Marc brings deep subject matter expertise, along with a unique ability to communicate complex modeling issues, to his volunteerism at CDISC. His intrepid spirit has forged new paths in the continual development of SEND, CDISC’s standard for non-clinical studies. Among many accomplishments, Marc led the SEND sub-team who published the first minor release of the SENDIG, version 3.1.1, which is listed in the FDA Data Standards Catalog.
Kim Minkalis
Programmer
The Griesser Group
February 2022 Volunteer Spotlight
Since 2009, Kim has dedicated her experience and passion for standards by volunteering on the ADaM and SDS Teams. One of the areas where she has parlayed her expertise is working with the QRS teams who develop ADaMIG and SDTMIG supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments.
Elisa Young
Head of Biostatistics
Accelagen
January 2022 Volunteer Spotlight
Based in Australia, Elisa recently and enthusiastically jumped into volunteering at CDISC. She serves on the CORE team, which is working to deliver a governed set of unambiguous and executable Conformance Rules for each Foundational Standard, and to provide a minimum viable product of an open-source execution engine for the executable Rules.
Kristin Kelly
Principal Consultant, Consultative Services
Pinnacle 21
December 2021 Volunteer Spotlight
Beginning in 2022, Kristin will lead the Submissions Data Standards (SDS) team who work on the SDTMIG. She is a seasoned volunteer who actively contributes her expertise to a variety of teams, including the Global Governance Group, CORE, QRS, SEND, and Controlled Terminology Relationships. Kristin is also a CDISC-authorized instructor, educating learners on SDTM Theory and Application.
Nikki Flores
Associate Director, CDM CORE (Standards, Technology & Solutions)
Gilead Sciences, Inc.
November 2021 Volunteer Spotlight
Nikki began volunteering at CDISC by contributing expertise to the development of Therapeutic Area User Guides. Her initiative, can do spirit and dedication have led to her serving as Lead of the CDASH Implementation Guide team who recently released CDASHIG v2.2 and is already working on the next release of the IG.
Nate Freimark
Vice President, Clinical Programming and Data Standards
The Griesser Group
October 2021 Volunteer Spotlight
Nate Freimark is a long-time CDISC volunteer who serves on the ADaM team, which he led from 2010 - 2017. He also contributes his expertise as ADaM lead on the development of many Therapeutic Area User Guides. Nate is a member of the SDS and Controlled Terminology teams as well as an authorized CDISC Instructor.
Ward Puttemans
Clinical Data Standards Manager
UCB
September 2021 Volunteer Spotlight
Ward co-leads the team that is developing a Controlled Terminology User Guide, which will direct users on implementing the set of codelists and valid values used with data items within CDISC-defined datasets. He also serves on the SDS Lab team.
Ward and SDS Lab team co-lead Dr. Erin Muhlbradt will be presenting at the CDISC Virtual Interchange on SDTM and SDTMIG Up-versioning and Its Effects on Specimen-based Lab Data: aka “Dude, Where’s my Data?"
Carey Smoak
Retired Statistical Programmer
August 2021 Volunteer Spotlight
Carey co-founded and co-led the CDISC Medical Device team since its inception in 2006. The team is currently working on the publication of the first version of the ADaM Implementation Guide for Medical Devices along with its Conformance Rules, which are anticipated to be released by the end of this year.
Bhavin Busa
VP and Head of Clinical Data Services and Operations
Vita Data Sciences
July 2021 Volunteer Spotlight
Bhavin Busa volunteers on the team that is developing the new Analysis Results Standard. He also serves as a Board Member for the CDISC Open-Source Alliance (COSA). Bhavin recently participated on the CDISC 360 project and co-authored the 360 White Paper.
Smitha Karra
CDISC SDTM SME
Employee of Clinical Solutions Group an IQVIA business, on behalf of Gilead Sciences
June 2021 Volunteer Spotlight
Smitha Karra co-leads the CT Relationships team, which recently released the Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2 . She also serves on the sub-team that develops SDTM QRS Supplements.
Richard Lewis
SDTM Consultant
Data Standards Consulting Group
May 2021 Volunteer Spotlight
Richard served as team lead of the recently released version 2.0 of the Study Data Tabulation Model Metadata Submission Guidelines. He is now volunteering on the team to develop ADaM Metadata Submission Guidelines.
Anna Pron-Zwick
Principal Global Clinical Dictionary Manager
AstraZeneca
This spotlight was featured in December 2020.
Anna serves on several Controlled Terminology teams and represents Controlled Terminology on the Global Governance Group.
Tatiana Sotingco
Associate Director, Clinical Data Standards Architect – Data Analysis & Reporting
Johnson & Johnson
This spotlight was featured in September 2020.
Tatiana leads the ADaM Team.
Victor Wu
Executive Vice President
Beijing Data Science Express Consulting Co., Ltd.
This spotlight was featured in June 2020.
As chair of the C3C, Victor has led various activities to promote CDISC in China. He coordinates the translation of CDISC standards into Chinese. Victor is also an authorized instructor in ADaM and SDTM.
Bill Houser
Senior Research Scientist
Bristol Meyers Squibb
This spotlight was featured in March 2020.
Bill has been contributed his expertise to the SEND team for over 10 years and served as Team Leader for three years. He currently advises SEND Team Leadership.
Dmitry Kosolov
Senior Principal Statistical Programmer
Parexel
This spotlight was featured in December 2019.
Dmitry serves as a volunteer on the Data Exchange Standards team and is a contributor to the team's projects - ODM v2.0 and Define-XML v2.1. He is an open source developer actively using CDISC Library to build tools that make it easier to implement the CDISC standards.
Mike Ward
Consultant Data Standards - Clinical Information and Process Automation
Eli Lilly and Company
This spotlight was featured in September 2019.
Mike led the CDASH Team from 2015 - 2020, bringing enthusiasm, expertise and dedication at every twist and turn.
Yumiko Asami
Manager, Data Intelligence, Biostatistics & Data Management
Daiichi Sankyo Co., Ltd.
This spotlight was featured in June 2019.
Yumiko led the CDISC Japan User Group (CJUG) ADaM team from 2011 - 2018, who produced the Japanese ADaM summary document for learners (Hajimete-no-ADaM).
Angelo Tinazzi
Director, Standards, Systems, CDISC Consulting, Statistical Programming
Cytel, Inc.
This spotlight was featured in March 2019.
Angelo serves on the ADaM Team and is an authorized ADaM Instructor. He is an active member of the E3C and co-leads the CDISC Italian User Network.
Ruiling Peng
CEO
Beijing Improve-Quality Technology Co., Ltd.
This spotlight was featured in December 2018.
Ruiling has served on the CDISC China Coordinating Committee (C3C) since 2012. She was the first person in China to become an authorized instructor of ODM and Define-XML.
Jordan Li
Biomedical/Clinical Research Information Specialist
Enterprise Vocabular Services (EVS), National Cancer Institute Contractor
This spotlight was featured in September 2018.
Jordan leads the Controlled Terminology team.
Christine Connolly
Associate Director, Data Standard Expert
EMD Serrono
This spotlight was featured in March 2018.
Christine leads the SDS team, which develops SDTM, as well as the Genomics and Biospecimens sub-teams. She also provides subject matter expertise to the CDASH and Controlled Terminology teams.
Hidetoshi Misawa
Group Lead, Program Data Management Group, Japan
Pfizer
This spotlight was featured in June 2018.
Hidetoshi chaired the Japan CDISC Coordinating Committee (J3C). His commitment to advancing the awareness of CDISC in Japan has been significant in promoting the use of CDISC standards in the region.
Joerg Dillert
Consulting Solution Senior Director
Oracle Health Sciences
This spotlight was featured in December 2017.
Joerg served as chair of the E3C for many years and remains an active member.
Kamiar “Mike” Hamidi
Associate Director, Global Clinical Data Standards
Merck & Co.
This spotlight was featured in June 2017.
Mike has served on various CDISC teams since 2010. His blend of enthusiasm, commitment and strong subject matter expertise have led him to positions of leadership and responsibility.
Trisha Simpson
Director of Global Integrated Standards
UCB
This spotlight was featured in September 2016.
Trisha co-chaired the CDASH team, co-led the Rheumatoid Arthritis Therapeutic Area team, served as representative on the CDISC Advisory Council, member of the CDISC Technical Leadership Committee, member of the EHR-to-CDASH (E2C) team, and the UCB representative on the TransCelerate Data Standards and eSource work streams.