Terri Blythe

Director, eData Management & Technology

Make sure you know what data you want to collect and stay as consistent as possible across all protocols for the drug.

A day in my life at Clinipace

Not sure there is a typical work day as it varies greatly from day to day depending on the stage of implementation.  However, it can be talking with our clients and/or project team members on any of the following items: data specification, edit check specification, workflow specifications, report specifications, internal testing, user acceptance testing, training clients and/or sites, project meetings and audits. I have also been helping in setting some standards for TEMPO implementation and creating training materials to document how each of the steps are accomplished.

 

My "a-ha!" moment

It really hit home the first time the FDA approved a drug and I had worked on years before.   Working in the Phase I area for a number of years, several of those projects never even make it to Phase III.

 

The most important consideration a client should take when undertaking a clinical research project

Make sure you know what data you want to collect and stay as consistent as possible across all protocols for the drug. Only collect the data you are really going to need, keep it simple and keep the database user friendly for the site (i.e. terminology and order).

 

Professional organizations

Society of Clinical Data Management

Clinipace Worldwide
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