Volunteer Spotlight

CDISC’s strength derives from the diverse perspectives of our community. Whether coming from a pharmaceutical organization, academic institution, regulatory agency, non-profit, or beyond, our volunteers bring a range of experiences and backgrounds that drive more meaningful clinical research. We invite you to read about our volunteers who contribute their expertise to facilitate the development of standards that are open and available to all.

David Neubauer
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
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
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
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
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
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
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
Marcelina Hungria

Owner
DIcore Group


December 2022 Spotlight

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
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.