A "Holistic" e-Clinical System: Be Wary of Managing Clinical Development With Blinders On

By Vladimir Pyagay, Clinical Solutions Manager, TransPerfect Life Sciences

If we were to survey all sponsors and CROs, asking what their biggest cost drivers have been since they have started conducting clinical trials, they would all mention the same thing – paper. Paper storage, maintenance and global express mailing drive total study costs up tremendously. Why is paper study management so costly?

• Paper forces duplicate copies of the same document in multiple locations (and many companies still keep “shadow files”), as opposed to one centralized location where all parties can access study documents on demand.
• Paper creates bigger inefficiencies – not providing a place to retain the same information about investigative sites and vendors – forcing those involved in the study to collect the same data (CVs, Medical Licenses, etc) repetitively.