CDISC and PhUSE Partner to Support FDA Computational Science Symposium

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The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) are pleased to announce an agreement to work cooperatively to facilitate the adoption and implementation of CDISC standards to streamline clinical research. Many CDISC staff and volunteers will be actively participating in a collaborative meeting, organized by PhUSE on behalf of FDA, to be held in Silver Spring, MD on 19-20 March 2012. This FDA Annual Computational Science Symposium is entitled “Update on Standards, Tools, and Process Initiatives across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle.”

The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) are pleased to announce an agreement to work cooperatively to facilitate the adoption and implementation of CDISC standards to streamline clinical research. Many CDISC staff and volunteers will be actively participating in a collaborative meeting, organized by PhUSE on behalf of FDA, to be held in Silver Spring, MD on 19-20 March 2012. This FDA Annual Computational Science Symposium is entitled “Update on Standards, Tools, and Process Initiatives across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle.”

The meeting will endeavor to advance work initiated at previous annual FDA Computational Science meetings by bringing together the FDA, industry and academia to provide updates on ongoing current initiatives within the FDA and to establish collaborative working groups to address current challenges related to the access and review of data to support product development. These collaborative working groups will pursue possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science, while exploring the advantages of using CDISC standards more extensively throughout the research process.

“Since supporting data standards is an essential part of the PhUSE Mission Statement, one of our vital activities is to collaborate with organizations like CDISC to ensure an efficient adoption of standards within the industry,” commented Benjamin Szilagyi, PhUSE Director of Industry Links. “This symposium is a great opportunity to discuss practical applications of these standards among day to day users and feed the results back to CDISC for further consideration. We therefore see the CDISC-PhUSE partnership as an important strategic alliance to drive efficiency and quality in our industry and bring innovative drugs faster to the market.”

"Since CDISC is primarily focused on standards development and training, we don't always have adequate visibility in the implementation and application of our standards on actual research studies,” added Wayne Kubick, Chief Technical Officer of CDISC. “So, we are very pleased to have this opportunity to work more closely with the PhUSE community, who can provide greater insight into the best practice use of standards, and foster creation of better tools to encourage more widespread global adoption of CDISC standards.”

Registration for this meeting has sold out at this point. Any who cannot attend should watch the CDISC and PhUSE websites for progress reports. The goal is to have the working groups, each with an overarching theme of standards, continue beyond the actual meeting to provide a collaborative testing environment to ensure the day to day implementation issues are being discussed and addressed and to share best practices broadly. Streamlining the access and review of data to support product development should ultimately benefit of patients worldwide.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 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 safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

ABOUT PhUSE
PhUSE is an independent, not-for-profit organization run by volunteers with over 1600 members worldwide. PhUSE provides the industry with the premier platform for creating and sharing ideas, tools, and standards around data, statistical and reporting technologies; PhUSE is supported by a community of professionals who are passionate about the advancement of clinical information. 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, Programmers, and eClinical professionals. The PhUSE mission is to Share – Contribute – Advance clinical information.

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Diana Harakeh
CDISC
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