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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"



Collaborate with FDA, Industry and Others to Improve

Product Development and Review

On March 15-17, 300 people from PhUSE, FDA, CDISC, and Industry gathered together in Silver Spring, Maryland for the 4th annual Computational Science Symposium (CSS). This event and ongoing collaboration is unique within our industry as it brings the key stakeholders from across the product development and review process to solve issues, explore new ideas and work together to improve the product lifecycle.

The meeting kicked off with FDA State of the Union where the FDA shared valuable information about how they are leveraging the standards, tools and processes to improve their review process. Lilliam Rosario and her colleagues provided real world examples of how reviewers are using the JumpStart program to assess the quality of their submission data, load the data into their various tools and provide standard analyses for the reviewers. This overall process has enabled the FDA to assess quality within two weeks of submission and put analyses in front of the reviewer within four weeks; a significant reduction in time within their process.

After the review of the JumpStart program, Armando Olivia provided an overview of the new and improved JANUS Clinical Trials Repository (CTR).  He shared, that as of January, 2015, the CTR is in production at FDA with over 60 trials loaded and ready for analysis. Within the final presentation, Steve Wilson explained that this was a different kind of conference – a collaborative working environment. Steve Wilson asked attendees to “move beyond their stake, roll up their sleeves and use their expertise to seek solutions”.

Throughout the event the working group projects collaborated on current projects and identified a number of new projects. These new topics included best practices to support the new electronic submission guidance, support the testing and implementation of Therapeutic Area User Guides (TAUGs), development of best practices and requirements for Statistical Computing Environments (SCEs), and the need for dynamic visualization of clinical data.

By the end of the Symposium, there was significant excitement about the current projects delivering value to the product development process and new projects that were kicking off innovative ideas. While all attendees understood that the challenges identified are not easy to solve, everyone was eager to roll up their sleeves and execute what could be achieved through collaboration.

As one new attendee said after the event:

The collaboration among sponsor, CRO and the FDA was a formula for success.
We're all there working together to solve problems and explore new concepts. The amount of
progress the small groups were able to make in a short
time frame
was impressive

View the Presentations and Posters here.

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