CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation

The healthcare industry, as well as regulatory bodies, have 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.

TOPIC

CDISC for Medical Device Companies: Progress Made and Best Practices from Pharma/Biotech Implementation

LOCATION

Capgemini Offices, South San Francisco

DATE

Wednesday, October 9th

TIME

5:30pm - 8:00pm (PDT)
 

PANELISTS

Carey Smoak - Roche Molecular Diagnostics - Sr Manager of SAS Programming, CDISC Device Team Leader

Debi Roy - Medivation - Head of Statistical Programming

Dan Diprimeo - BioMarin Pharmaceutical - Director of Statistical Programming

Peng Yang - Santen Pharmaceutical - Associate Director, Head of Statistical Programming

Moderated by:

Ale Gicqueau - Clinovo - President & CEO

ABSTRACT

The healthcare industry, as well as regulatory bodies, have 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.

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