Friday, December 26, 2008

Importance of Clinical Overview eCTD Module 2.5

Welcome back to Dante's Blog. This is written by the President of Dante.

eCTD Module 2.5, the Clinical Overview {CO}, is one of the most important documents in any regulatory submission. CO M2.5 provides FDA with its first impression pertaining to the merits of the drug filed, its quality, content and indication positioning. A "poor" CO will not trigger a refusal to file {RTF}. A CO without quality and content will have a convoluted path to approval.

Remember - There is no short-cut to quality. Quality control ensures the integrity of your data.

Realize ROI - return of investment. Most pharmaceutical sponsors do not understand the importance of the CO. Most do not know the ROI on utilizing QC early.

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