Well, here we are again, trying to get the last blog in before we go back to school!

Hope everyone had a wonderful summer….the Octagon team here has been hard at work trying to perfect our current ViewPoint FUSE system while planning for our next major release at the end of the 4th Quarter. With all the excitement surrounding this next release, it got us thinking of how exciting EDC really is! I mean, to be able to have data at your fingertips once entered and for it to be so clean because edit checks fire upon entry is amazing.

My name is Dan Crawford and I’m the Director of Clinical Data Strategies here at Octagon Research Solutions, Inc. Along with Dawn Kaminski (who you’ll be introduced to shortly), I will be blogging on the topic of EDC, Data Management and CDISC. Before we begin, we’d like to tell you a little bit about ourselves.

When I began my career in Data Management, gas cost $1.16/gallon, I was watching Goodfellas and listening to The Cure and Guns N’ Roses. The year was 1990.

Wow! I am just now recovering from a week in Boston at the 44th Annual DIA Meeting.

It was a great meeting with a record number of attendees (8700+), sessions, and exhibitors. I was fortunate enough to have been on the Program Committee for this meeting as I will be next year and in 2010. It is a 3 year commitment and has been an eye opening experience.

Let me share with you all some thoughts about the meeting, beginning with the Keynote.

Thank you FDA for finally getting rid of one of the most confusing terms in regulatory language - The Approvable Letter! Many a project team meeting have I had to over enunciate APPROVAL vs. APPROVABLE to the hoards of waiting listeners when the FDA Action period came to a close. Now, as announced by FDA yesterday and found here on their web site http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html we have a much more focused approach to the conclusion (maybe) of the review process - The Complete Response! I love it!!