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.

Now, I have two teenage children. My daughter is off to college this summer and when my son is not playing the guitar, he attends Middle School.

I have been with Octagon since 2005 and split my previous work experience between “Big Pharma” and CRO’s. I have held positions from Data Coordinator to Director of Data Management and everything in between. I’ve worked on 100’s of clinical trials from small Phase I trials to global patient registries. Over the years, I’ve collected and cleaned data using paper, fax and electronic data capture based systems.

My name is Dawn Kaminski and I am a Data Management and EDC architect here at Octagon Research Solutions.

I am 33 years old and have been in the Pharmaceutical industry for over 11 years. I am married and have two beautiful girls, ages 4 and 5.

They keep me on my toes! I thought I had a full time job working in Data Management before kids and now, add 2 very active children into the mix-whew! But enough about my lack of sleep!

I have been involved in almost every aspect of clinical trials. Throughout my career I have worked my way up the corporate ladder from Data Coordinator to Project Manager to Director of Data Management. And over that time I have seen a shift in the DM industry from Paper-centric to Fax Based technology to EDC.

Just to give you some history, when I started in the Industry in 1997, Gas was $1.22 a gallon (ah…those were the days!), Leonardo DiCaprio and Kate Winslet were “never letting go” in Titanic, Harrison Ford was taking back his plane in Air Force One, and I was rocking out to the sounds of the Spice Girls, Puff Daddy (whatever his name is now) and No Doubt.

I also was working on a Fax based system, which I thought was the best invention ever (and truthfully-I still love it!) It was light years ahead of paper systems and had a glimpse into the future of EDC.

Our Vision

In the spring of 2007, we were tasked with the responsibility of creating an EDC system. This certainly was both an exciting and challenging time. Anyone who has ever been in data management has said in the past “If I could build a system, it would have…” Well, now was our time to put up or shut up.

We wanted our system to be both user friendly as well as a fresh face in the EDC industry. We combined our years in data management, CDISC/SDTM expertise, and vision and all those combined became ViewPoint FUSE.

Does your system measure up to ours? Check out our EDC Top Ten List (sorry Letterman was not available) and see for yourselves.

Until next blog………………..D & D

Top 10 Things your EDC System Should Have:

10. 100% Web-based, no software installation necessary

9. Dynamic eCRFs

8. Human readable audit trail, 21 Part 11 compliant

7. Suite of 11 standard reports

6. Integration of source document review status into EDC

5. Regulatory Compliant CRFs to CDER and CBER

4. Ability to export data 24/7

3. SDTM compliant variable names

2. Full validated “Base Study”

1. Cool icons!!!