Reflection to P&G Electronic Data Capture and Clinical Trial Management

Memo

To:	Senior Management
From:	Allison DeLorenzo
Date:	February 11, 2014
Re:	P&G Electronic Data Capture and Clinical Trial Management

This memo is prepared in response to the presentation held on Tuesday, February 11, 2014 with the hired consultant team regarding possible alternatives for P&G’s current clinical trial management process. As stated in the presentation, the three issues P&G is facing are process efficiency, cost, and shortening the time it takes to enter the data-lock phase.

After careful analysis of the three alternatives (improving the paper-based process, digital imaging process and web-enabled EDC), my recommendation for P&G is to implement the web-enabled EDC. This is based upon the fact that the internet is changing the way business is conducted around the world. P&G should use this opportunity to adopt this new technology and embrace the internet and its capabilities. 

In addition, the EDC trials were highly successful and proved the system reduces the errors and inaccuracies of human data entry and completely eliminates the double-entry system.  During the trial of the EDC, the duration of time from the final patient visit to data-lock improved from eight weeks to a mere four weeks. There was also an improved quality of patient data, since errors were being addressed throughout the process.   

This is the only alternative that addresses the problem and the symptoms; the other two alternatives only address symptoms. Once the sites and sponsors are well versed in the EDC system, the entire process will be more efficient and effective.