Service Description

We hired Novella to assist with data management on a large registry study. (Novella is now owned by Quintiles) Novella had experience with Device studies and they have a good Data Management Group. They are supplemental to our building of a database providing us with consulting on data management tricks and requirements since we have NO in-house true data manager.

What Went Well

The CRO has a great Data Management team. From the beginning they understood our needs and treated this project like their own study. We never argued about scope or $$. They just did whatever we needed and charged a reasonable rate to do it.

What Could Be Improved

We actually had almost no issues at all. They have been really great and helped us with exactly what we needed. They are an extension of our clinical department and don't ask me for days off. Can't be better.

Lessons Learned from the Experience

Yes, our CRO did think out of the box. Our EDC company was made up of good technical data programmers. They understood the database. But they are not data managers. Our CRO had good solutions to practical EDC problems that the vendor of the EDC was not aware of or able to come up with.