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I am always looking for qualified biometrics professionals who want to grow their careers and be part of dynamic and fast paced Bay Area pharmaceutical and biotech organizations. Please contact me if you are looking for a new position in Biometric Senior Management and Statistical Programming.

PhUSE Computational Science Symposium

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Over the last five years, the CSS has grown from its infant years, passed through adolescence and matured into a successful collaboration leading to innovation within our industry. This years Symposium commenced on the Sunday evening with a welcome and introduction to the great work being done across the Working Groups and all the projects. Working Group volunteers had opportunities to network with their fellow colleagues, put names to faces, and look forward to the next two days.  

The first-ever 'Semantics 101 for Pharma' workshop helped bridge the gap between legacy clinical data processes and the introduction of innovative ways to look at clinical information. Thirty people registered and over 50 attended, showing the significant interest in this topic.

The annual FDA session on Monday, introduced us to real things happening within the FDA, including an update on the guidance, the reality of what is being seen in the CDISC data being received, and the importance of the data reviewer guides published by PhUSE projects. Over 30 posters were presented on a variety of topics and a number of Working Groups proposed new projects.

By the end of the event, there was significant excitement around current and new projects and while all attendees understood 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 industry, regulatory agencies, and standards organisations was a formula for success. I could see everyone working together to solve problems and explore new concepts, and the amount of progress the groups made in a short time frame was extraordinary".

Thank you to everyone that contributed to yet another extremely successful Symposium, and we look forward to seeing you all in 2017.
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CDISC Upgrades Standard for Clinical Trial Registries (CTR)

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The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file.

The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 20-item WHO Trial Registration Data Set as well as EudraCT specific extensions.

“The CTR standard maximizes the re-use of existing CDISC transport standards by extending the Operational Data Model (ODM-XML) and including Study/Trial Design Model (SDM-XML) content,” CDISC said in a statement. “This makes the standard a more general solution that any trial registry could potentially use as the means to populate their registry with structured content from a clinical trial sponsor’s systems.”

CTR-XML will help companies harmonize messages to international registries, and technology vendors will be able to support a "write once, use many times" tool based on a single XML file, CDISC said. The standard is based upon the common elements mapped between the registries, which are based upon the 20-item WHO Trial Registration Data Set.

“This standard will save the industry a lot of time in registering trials with multiple registries and is an essential step toward creating registries that house consistent, high-quality data, which will make them more useful to patients seeking research trials,” said Paul Houston, head of the CDISC Europe Foundation. “The next stage will extend the standard, creating an underlying structured protocol standard, results summaries and Identification of Medicinal Products (IDMP) compliance (an ISO standard), to further increase the richness, reliability and traceability of registry information.”

CDISC is looking for volunteers and sponsors to join the CTR team and those interested can email for details.

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