IBM Clinical Development Blog

Yes, You CAN Learn to Build Your Own Study Database (We'll Show You!)

[fa icon="calendar"] Nov 3, 2015 10:00:00 AM / by Greg Pack

Topics: CRO, clinical data management

eCOS Study Build Program Puts YOU in The Driver's Seat 


"Clinical research is all about control – and those who choose careers in this industry want to retain as much control over a project as possible. eClinicalOS plays very nicely with this ideal given that it encourages those working with it (programming, conducting UAT, cleaning, etc.) to become self-sufficient."  
-Matt Dickason, Managing Director, Renaissance Associates* 
With trial costs at an all-time high, every minute of every day has a dollar amount tagged to it – and building out a study in a data management platform can be extremely time-consuming. So instead of paying other companies to build databases, what if  you could have someone trained in-house who can do it for you? That’s both productive and smart.

eClinicalOS' Mentor Build/Certified Designer program is unlike any in the industry. When you participate in our onsite build session (which usually takes about a week), you'll leave with the skills you need to build or modify your own study databases. (That's huge!) You'll also have the option to take a test and become an official Certified Study Designer. Imagine the possibilities: You can build and modify your own study databases, train others in your organization, or even contract employees out to build studies for other companies.
From Data Manager to Certified Designer – in One Week 
An eCOS Case Study 

When Clinical Data Manager Erin Piller participated in the eClinicalOS Mentor Build Program and became a Certified Study Designer, she gained a valuable skill – and her employer, Renaissance Associates, benefitted, too. Read on to find out how she was able to get certified, overcome her fears, and build value within her research organization – all in 4 days of training.

Q: Tell us about yourself!

Erin: I am the Data Manager at Renaissance Associates, a specialized CRO based in Orange County, California. I’ve touched every project from start to finish and have developed and grown the data management side of things since the beginning. In my day to day, I’ll do anything from protocol review to creating CRFs to programming databases. 

Q: How did you find out about eClinicalOS, and the mentor build program?

Erin: We discovered eClinicalOS during a recent RFP process for a client. After performing due diligence activities on multiple EDC vendors, we recommended eCOS to the client as our primary choice. The certified study designer training program was definitely a factor in our decision. The reason we recommended eCOS was in large part due to our ability to retain and perform all database programming activities on behalf of and with the full support of our study sponsor.

Q: What was your background and experience level going into the training?

Erin: Prior to working at Renaissance, my previous experience was in the advertising industry with a focus on research and media planning. In my work at Renaissance, I programmed many databases, but had no experience with eCOS.  

Q: How did you prepare for your certified designer training?

Erin: I sat through a couple of webinars, then got my hands on a Sandbox account. I played with the Sandbox feature as much as I could, and started poring through the manual. I was looking at just about anything I could get my hands on, preparing myself for my trip to Raleigh.

Q: What was the training experience like for you?

Erin: Last year, I had a weeklong training effort with [eCOS Trainer] Joseph Maxey. I was confident that I could develop a useable database, even though we had a project with some tight deadlines. It was a very intense week of training. I’d say by the third or fourth day it was starting to make a lot of sense. 

I loved attending the training. Everybody at eClinicalOS was super nice. By the end of the week, I felt like I was part of the company. It was a fun, relaxed and valuable experience.

At the end of the week I was somewhat nervous to leave Raleigh and come back and build a study on my own. As with all studies, there was a mandate that we adhere to strict budget parameters. I wanted to learn not only the right way to program, but the right way to program to ensure the efficient and cost-effective use of the eCOS system by all stakeholders. 

Q: How are things going now?

Erin: There was an unanticipated delay in study start, but upon leaving the training, I was confident that I could have made it work if we were told to “go live” when originally scheduled. So kudos to you guys for getting me up to speed that quickly! I think that was amazing.

So far everything’s working great. The client is really happy with how the database was put together, and that we were able to build in some features that even they didn’t know they would want.

Being able to do that on our first study using eClinicalOS - no templates or anything to work from - just amazed all of us here at Renaissance (as well as the client). So going forward, I have a knowledge base of eCOS to use for future studies. Of course I’ve learned a lot along the way, but I also have templates that I can already build from, which are huge timesavers. So I’m really looking forward to our next study in eCOS, because I want to see how fast I can get.

Stay tuned for part 2 of this story, in which we interview Trainer Joseph Maxey to get his side of the experience!  

*Renaissance Associates is a specialized Contract Research Organization (CRO) located in Newport Beach, California. Renaissance Associates focuses on late phase biopharmaceutical and early/late phase medical device/diagnostic study design and execution.

 If you would like to contact Renaissance Associates for further information, please see their details below:

Renaissance Associates
1600 Dove Street, Suite 330
Newport Beach, CA 92660



Free webinar: How to Cut Your Study Build Time in Half

Interested in some tips and tricks on how to cut your study build time by as much as 50%? Watch our previously recorded free webinar

Share this post

Greg Pack
Written by Greg Pack