Career Center

Event

Title:

 

Silicon Valley BioTalks

Date:   March 7, 2012
Time:   5:30pm - 7:30pm
Location:  

SNR Denton US LLP
Tashkent Conference Room
1530 Page Mill Road  - Suite 200
Palo Alto, CA 94304-1125

Sponsor:    
Event details:  

To register, click here.

Top-tier panelists from leading pharmaceutical companies share their experience and best practices on clinical data conversion to CDISC standards. The panel discussion will be followed by a networking session with food and drinks. Click here for event details.
 

How can CDISC standards accelerate FDA submissions?

What are the best practices to efficiently implement CDISC standards?

What are the initiatives in place to enhance CDISC expertise in the industry?

Join the discussion with CDISC experts!

Abstract: clinical trials have become increasingly complex and, as a result, costly. A report by Deloitte on the world's 12 largest drugmakers shows that the average cost of bringing a product to market rose by more than 25% to greater than $1B in 2011, from $830M in 2010. And, for new drugs, it typically averages 10 to 15 years from discovery to enter the marketplace. Life science companies and service providers need innovative ways to improve study performance and minimize their risks.

Complying to CDISC standards is one way to streamline the clinical trial process. As the standard format recommended by the FDA for clinical trial data submission, using CDISC standards:

  • Facilitates the FDA review process
  • Improves efficiency for clinical data exchange
  • Ultimately reduces costs and speeds up time to market 

CDISC experts include: John Brega, PharmaStat, CDISC Implementation and eCTD Submissions; Carey Smoak, Roche Molecular, Senior Manager, SAS Programming, CDISC Device Team Leader; and Dave Borbas, Jazz Pharmaceuticals, Senior Director, Data Management. 

 

 

 

Additional information and/or registration:  

 

Registration is free. To register, click here.

 


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