From: Michael Owings [Michael.Owings@phaseforward.com] Sent: Monday, January 03, 2005 4:02 PM To: 'fdadockets@oc.fda.gov' Cc: Alan Pollack Subject: Docket: 2004D-0440: Phase Forward Comments Please find attached our comments to Docket 2004D-0440, Guidance for Industry: Computerized Systems Used in Clinical Trials, September 2004. Regards, Michael Owings Michael Owings Vice President, Quality and Regulatory Compliance Phase Forward 880 Winter Street Waltham, MA 02451 USA T: 781.902.4456 F: 781.890.4848 www.phaseforward.com This message contains privileged and confidential information intended only for the use of the addressee(s) named above. If you are not the intended recipient of this message, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination or copying of this message is strictly prohibited. If you have received this message in error, please immediately notify the sender by return electronic mail and delete the original message without retaining a copy.