What is the Current State of eTMF?

By Ed Miseta, Chief Editor, Clinical Leader

So much has been written and published about the use of electronic trial master files (eTMFs) that it is difficult to understand exactly where the industry stands on acceptance of the technology. At times it seems some firms are not even referring to the same thing when referencing eTMFs. Enterprise software company NextDocs has conducted a survey of 60 companies to gain both qualitative and quantitative insights into the use and perceptions of eTMFs by end users. The results have been released in a report titled The State of Trial Master Files. 

“The biggest trend we see in the clinical space is a gap that exists between the great strides made by some of the industry leaders (especially ones where legacy document management is not as entrenched) and firms that seem to be laggards in regard to adopting the technology,” says Kevin Potts, VP of marketing for NextDocs. “The firms that are slow to adopt the technology seem to believe eTMF is nothing more than a system used to scan and archive documents after you are done using them. Many companies will tell you they are already using eTMF, but the bigger question is what are they really doing with it.”