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.