AUSTIN, Texas
The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) announced today an evolution of their partnership to strengthen their work around the development and implementation of beginning-to-end standards.
CDISC and PhUSE have enjoyed a productive, working relationship for over 13 years. The two non-profit organizations partner to further each other’s mission, with CDISC, its members and volunteers providing their expertise to develop global, platform-independent data standards, and PhUSE and its over 8,000 members serving as the industry voice to regulatory agencies and standards organization with expertise in implementing standards. CDISC and PhUSE combine efforts on key initiatives, around end-to-end standards and semantics, strengthening an interdependent process.
“I am so impressed with the members and leaders of PhUSE,” commented CDISC CEO and President David R. Bobbitt. “PhUSE does an exceptional job of facilitating the implementation of CDISC standards. I look forward to our expanded partnership in the creation of more resources and tools to support implementers around the globe.”
“Since our inception, the sharing of ideas around data standards and tools for statistical and reporting has been a cornerstone of all our volunteer-driven efforts,” stated PhUSE Founder Stephen Bamford. “CDISC has always been on the forefront to drive the creation of standards. We look forward to further strengthening our collaboration and continue to help both regulators and the industry to implement these standards.”
Currently, CDISC and PhUSE are collaborating on several key projects to optimize data standards and provide best practice guidance on standards implementation. To further edify their partnership, the two organizations will sponsor mutual events, collaborate to create start-up guides, and hold joint membership drives, all with the goal of helping implementers, programmers, statisticians, data scientists and their organizations make better use of industry standards and facilitate their implementation.
ABOUT CDISC
CDISC is a 501(c)(3) global, non-profit organization that develops data standards to foster smarter research and enable connections to healthcare. CDISC standards allow data to speak the same language, by providing common formats for data collection, data sharing and data analyses to make the most of the valuable information offered by patients participating in research studies around the globe, enabling researchers to discover new treatments, find breakthroughs, and unlock cures. CDISC standards are required for regulatory submissions to the U.S. FDA and Japan PMDA, endorsed by the China CFDA, and requested for use by the European Innovative Medicines Initiative (IMI). The suite of CDISC standards is freely available on the CDISC website.
CDISC is funded through the generous support of over 400 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events and charitable contributions. To find out more about how to support CDISC and get involved, please visit www.cdisc.org.
About PhUSE
PhUSE, Share – Connect – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical data science. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and clinical data scientists. All PhUSE deliverables are available freely through the PhUSE website.
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CONTACT
CDISC
Nicole Harmon, +1-512-363-5826
nharmon@cdisc.org
