Roche, Medivation, Santen and Biomarin Will Discuss CDISC Implementation Challenges at the Next Silicon Valley BioTalks

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Panel composed of CDISC experts from Roche, Medivation, Santen, Biomarin and Clinovo will discuss and share ideas around the topic: “CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation”.

BioTalks
We are looking forward to discussing the latest strategies favoring CDISC Implementation.

The next session of the Silicon Valley BioTalks, a panel discussion and networking event sponsored by Clinovo, will take place on October 9th, 2013 at the CapGemini South San Francisco offices. The panel of experts from leading medical device and pharmaceutical companies will discuss the topic “CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation”. Free registration is open on clinovo.com/biotalks.

Now in its seventh session, this Silicon Valley BioTalks will host a panel of CDISC experts from leading pharmaceutical and medical device companies. The panel will discuss progress made regarding the implementation of CDISC standards in the past decade. It will be composed of CDISC thought-leaders: Carey Smoak (Roche Molecular Diagnostics, Senior Manager of SAS Programming, CDISC Device Team Leader), Debi Roy (Medivation, Head of Statistical Programming), Dan Diprimeo (BioMarin Pharmaceutical, Director of Statistical Programming) and Peng Yang (Santen Pharmaceutical, Associate Director, Head of Statistical Programming). The panel will be moderated by Ale Gicqueau (Clinovo, President & CEO). The Silicon Valley BioTalks will also include a networking session to facilitate discussions amongst attendees on the latest challenges around CDISC standards.

Pharmaceutical companies began adopting CDISC standards, such as SDTM (Study Data Tabulation Model), in 2004. By 2016, all data submitted to the FDA by pharmaceutical companies will need to meet CDISC standards. Although medical device companies may have until the next MDUFA (Medical Device User Fee Amendment) to comply with CDISC requirements, many companies are already implementing the medical device standards published in December 2012. ”At Clinovo, we are witnessing an acceleration in the adoption of CDISC standards”, states Ale Gicqueau, President & CEO at Clinovo. “We are looking forward to discussing the latest strategies favoring CDISC Implementation”.

Clinovo, a trusted CDISC® Registered Solutions Provider and Gold Member of the CDISC organization, is sponsoring the event. Clinovo has years of experience delivering SDTM conversion, training, and support services to pharmaceuticals and medical devices companies in the US and Europe. Clinovo developed CDISC Express, the first open source CDISC mapping tool. The recent 1.1 release of CDISC Express follows the new SDTM 3.1.3 specifications. The existing domains have been updated with more comprehensive variables and seven new medical device domains have been added from the new SDTM medical device guide.

Silicon Valley BioTalks is a premier event for pharmaceutical and medical device professionals to build their knowledge and expertise. Since its launch in June 2011, the Silicon Valley BioTalks gathered over 300 clinical trials professionals from the Bay Area and beyond. The panel has featured over 30 influential clinical trials industry experts, from leading life science companies including Roche, Abbott, Santen, Geron and Theravance. Read about the latest sessions on clinovo.com/biotalks.

About the CDISC organization

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission, and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website.

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Sophie McCallum
Clinovo
408-773-6258
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