Foster City, CA
22nd February 2018
Registration will open soon.
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Registrations per company are limited to 20% of maximum attendance.
Marching at the Double-quick to Successful Submissions with Innovative Automation Within the Study Lifecycle
In the past ten years, new standards have affected the entire drug development lifecycle from data collection through regulatory submission. Developed by CDISC, ICH, NCI, HL7, W3C, ISO and even FDA, they have the potential to support more seamless interoperability and process automation. It’s up to us in the industry to make that potential a reality through the effective use of standards by the software and processes we develop and use.
Looking ahead, new standards and processes will integrate new sources of data, such as automated biometric data capture and next-generation genomics data, into the familiar world of clinical data collection and analysis. These new data types are key to developing the next generation of precision pharmaceuticals. The standards to support them will emerge from industry and ultimately find their way into the standards catalogues of regulatory agencies.
This event will focus on practical ways the industry can respond to the challenges of improving efficiency and integrating new data sources. We’ll hear about case studies in process improvement that accelerated time to successful submissions, and about software tools and techniques to integrate new data types and enable process efficiencies.
Foster City Community Center 1000 E. Hillsdale Boulevard - Wind Room
Foster City, CA
Will be announced soon.
Catering and refreshments will be provided throughout the day.
Lisa Brooks, Iris Statistical Computing
Maoli Lupenui, PointCross
If you have any questions, or require any information, please contact the SDE Co-Chair.
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