CDISC and PhUSE Announce Signed Partnership in Support of Ongoing Collaboration

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The Clinical Data Interchange Standards Consortium (CDISC), and the Pharmaceutical Users Software Exchange (PhUSE) announced today the signing of a Memorandum of Understanding (MOU), strengthening the partnership for the benefit of stakeholders conducting regulated clinical research and product development.

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Both CDISC and PhUSE see this growing partnership as a significant step toward ensuring that our joint projects are complementary and productive, further strengthening what is truly an interdependent process.

The Clinical Data Interchange Standards Consortium (CDISC), and the Pharmaceutical Users Software Exchange (PhUSE) announced today the signing of a Memorandum of Understanding (MOU), strengthening the partnership for the benefit of stakeholders conducting regulated clinical research and product development.

The CDISC-PhUSE MOU furthers the mission of each organization collectively with (1) CDISC focusing on development of global, platform-independent data standards; and (2) PhUSE focusing on the implementation and use of CDISC standards. The two organizations will combine efforts and seek to collaborate on key initiatives such as the PhUSE Computational Science Symposium (CSS) Working Group projects, many of which already directly involve the testing and implementation of CDISC standards. The Working Groups are a collaborative effort between PhUSE, the FDA, industry and the CDISC community. In addition to these projects, CDISC and PhUSE will cooperate on joint marketing and communications activities, particularly around CDISC Interchanges and PhUSE annual events.

“CDISC and PhUSE have been participating in a number of collaborative and overlapping projects, such as initiatives around end-to-end standards, Therapeutic Area standards, semantics and standards for FDA submissions,” said Wayne Kubick, CDISC Chief Technology Officer. "Both CDISC and PhUSE see this growing partnership as a significant step toward ensuring that our joint projects are complementary and productive, further strengthening what is truly an interdependent process.”

“PhUSE and CDISC have built a strong partnership focusing on the implementation of the CDISC standards,” Chris Decker, PhUSE/FDA Liaison, shared. “Part of this partnership includes the shared initiatives between CDISC and PhUSE within the Computational Science Optimizing Data Standards Working Group, a group dedicated to working on tools and processes to support the successful implementation of the CDISC standards by both Industry and Regulatory agencies.”

PhUSE and CDISC will be hosting complimentary events during the same week in March 2015 in Silver Spring, MD, with the PhUSE Computational Science Symposium (CSS) occurring 15-17 March, and the CDISC Intrachange occurring 18-19 March. At both events, parallel discussions on the CDISC standards will occur from the different vantage points of development (at CDISC Intrachange) and testing and implementation (at PhUSE CSS). Highly anticipated at both meetings will be strong participation from the FDA. Recent documents released by FDA, the FDA Industry Guidance: Regulatory Submissions in Electronic Format and the Study Data Technical Conformance Guide, will be topics of discussion throughout the week. The CDISC Intrachange is open to those who develop, or are interested in developing CDISC standards, and those who would like to address computational science needs in support of regulatory review are welcome at the PhUSE CSS.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with over 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safe and effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research. For more information, please visit the CDISC website.

ABOUT PhUSE
PhUSE, Share – Contribute – 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.

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Andrea Vadakin, Manager of Public Relations
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