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.