Free Paper: CDISC For Medical Device Companies

 

In 2013 Clinovo hosted the Silicon Valley Biotalks on ‘CDISC for Medical Device Companies: Progress Made and Best Practices From Pharma/Biotech Implementation’ at the Capgemini Headquarters in South San Francisco.

This paper is the transcript of the panel discussion that evening.

 

Pioneering cloud computing for clinical trials

The healthcare industry, as well as regulatory bodies, has been hard at work in the standardization of clinical trial data. The need for data transparency, traceability, and auditability has continued to increase, in line with the cost of studies and the amount of data submitted to the FDA. As a result, much progress has been made in the past decade in creating standards to ease data exchange and interoperability as well as speed up the regulatory review process.
 
Pharmaceutical companies started adopting CDISC standards, such as SDTM, in 2004. While these standards have been recommended by the FDA, they have never been required. Therefore, it comes as no surprise that many have welcomed the recent announcement that, by 2016, all data submitted to the FDA by pharmaceutical companies will have to meet CDISC standards.
 
 

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