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 4^th 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.

Of course, over the past few years we have not seen as many people embrace EDC in the industry as we originally thought. So, the question is why has it taken EDC so long to over take paper-based trials and why are people still unhappy with EDC?  After speaking with some of our associates in the industry, we realized that there are many reasons why EDC is not as “on fire” as it should be.  One reason we are focusing on today is process.

EDC is meant to be an Electronic means of capturing clinical trial data.  Electronic is the key here….this means a change in process and procedures for all those involved. No longer is the primary onus on Data Entry staff to enter the data, now the study coordinator acts as the DE staff. They enter the data into the EDC screens and edit checks “fire” online indicating possible entry or transcription errors. So the work which DE staff would manually do is already done.

This does not mean that Data Management goes away completely. Staff still needs to clinically review forms for overall accuracy. They still need to check those things which a computer is never going to find, like an exacerbation of a Medical History which should be recorded as an Adverse Event. But, the highlight here is a change in paradigm…a shift in responsibilities.

And lets not forget about the all-important CRA role. They still need to source doc verify 100 % of all forms, however, they are not spending their time highlighting blank values, or values outside of the range because the system does it for them. So, they can spend most of their time performing true CRA tasks:  Reg Doc Review, Drug Accountability and Monitoring Reports.

The take home message of this installment is that to force an antiquated process on a new shiny product like EDC is not fair. Times are a changing….process needs to as well.

Blog you later…………D & D

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!!!