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.

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

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.