The Clinical Data Integration Standards Consortium (CDISC) format has become the de facto worldwide standard for clinical trial data submissions and review. The US FDA and Japan PMDA require the CDISC format for clinical data submission. The China NMPA and Europe EMA recommend the format.
CDISC is a global community of research experts who have been taking a rigorous and collaborative approach to develop and advance high-quality data standards for clinical research for more than two decades. This provides clarity to the complex nature of analyzing clinical trials data, leading to accelerated breakthroughs in global health.
SAS has been a Platinum Member of CDISC since its inception and JMP Life Sciences joined as a Gold Member in 2020. We will continue to support and collaborate with CDISC as a Gold Member for the 2022-2023 membership cycle.
“Being involved with CDISC has helped us lead the way for development of standardized tools for clinical trial data review,” says Sam Gardner (@SamGardner), JMP Senior Product Manager for Health and Life Sciences.
Why the CDISC format is important to JMP Clinical
JMP Clinical is one of the first professional clinical software packages to build on the CDISC data format. JMP Clinical takes advantage of the standard data format to streamline clinical trial safety evaluation and data quality assessment.
“JMP Clinical is an outstanding success story for CDISC,” says Dr. Wenjun Bao (@Wenjun_Bao_JMP), Director of Advanced Analytics R&D. Distinguished Research Fellow Dr. Russ Wolfinger (@russ_wolfinger) adds, “Coding against the CDISC standard has allowed us to provide consistent, broad, and deep visual analytics within a dynamic and easy-to-use interface.”
JMP experts have supported CDISC with their talents and knowledge, as well. Dr. Geoffrey Mann (@geoffrey_mann), Manager of Advanced Analytics R&D, served as the metadata team lead for the CDISC Analysis Data Model (ADaM) working group. Wenjun was elected to and serves on the CDISC Board of Directors (2020 -2026), where she has had the opportunity to contribute to the Blue Ribbon Commission, publish papers on real world data and accelerating drug discovery, and speak at CDISC annual interchanges.
Wenjun was also invited to submit a paper to the CDISC special issue of the Journal of the Society for Clinical Data Management, which was accepted with the title “CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation.”
“This paper was a true team effort and a good showcase for JMP Clinical,” Wenjun explains. “I look forward to more joint efforts between JMP and CDISC in scientific and technical areas.”
“Working with the CDISC organization has allowed us to gain better perspectives from the many experts who have contributed to the data models,” says Geoff. “Strong contributions from clinicians, medical writers and statisticians from the FDA, pharmaceutical companies, CROs and academia have helped us gain a clear understanding of the needs of our customers in the clinical trials business!”
Hi @isabelleswaenep, we are waiting on all external communications, including on LinkedIn, about this topic. The product management team will advise us about the appropriate time to share this info.
Hi Isabelle. Great question. . @isabelleswaenep . I inquired last week about making this more pubic, but after much conversation, was told it is premature. I believe Sam Gardner @SamGardner and Chris Kirchberg @Chris_Kirchberg are on it and Jessica Marquardt @J_Marquardt will help craft a public message when they give the go-ahead. It will happen closer to the time JMP 17 is finalized this autumn, we hope!
Is it possible to define an official post for LinkedIn to share with CDISC customer? France for example has a specifc group in LinkedIn.
Many thanks.
@gail_massari Good question! JMP Clinical uses CDISC as input data format. The results are presented in the interactive plots and tables following ICH guidance and JAMA rules for clinical data presentation.
- ICH 3 Guideline for Industry Structure and Content of Clinical Study Reports https://www.fda.gov/media/71271/download
- JAMA Instructions for Authors: https://jamanetwork.com/journals/jama/pages/instructions-for-authors
@carla_paquet1 I believe that every member of CDISC should be JMP Clinical customer. If they are the CDISC members, that means they are in clinical trial space with the data ready to analyze in JMP Clinical.
@ChulHee_JMP yes, We should help to promote CDISC awareness in Korea. With @DaeYun_Kim as Korea CDISC Coordination Committee member, we are in good position to have joint effort with CDISC to promote CDISC and showcase the JMP Clinical as an amazing successful story for CDISC 
.
Hi @J_Marquardt and @SamGardner . Is it possible to post something like this to the public area of the Community as a blog? @arati_mejdal We get questions from customers about our standards often. For example, from last week's reliability Mastering session, not about CDISC, but about pharma:
Q: From a QA perspective do you have documentation to support your JMP analysis process establishing shelf life for a pharmaceutical drug product which FDA has approved. A: In terms of shelf life, we’re following ICH Q1E guidelines.
Hi @Wenjun_Bao_JMP ,
I have been told you may be able to let us know if this Platinum Membership was involving Marketing advantages and which ones.
Carla
Looking forward to adopt CDISC as a standard in Korea as well, soon.
