eTMF Use Is Still Not Nearly As High As It Could Be

eTMF Use Is Still Not Nearly As High As It Could Be

January 8th, 2014 // 1:10 pm @

The use of eTMFs, or electronic Trial Master Files, is going up, according to a recent survey by NextDocs, but more than 50% of people who responded to the survey said they are still doing much of their clinical trials on paper.

This survey was taken in the beginning of 2013, polling about 50 life science firms, and 28% were found to still be using a paper system to handle their documents for clinical trials, and about 20% were using some sort of hybrid system. This meant that they had some of their clinical trial documents on paper, and some of them were in an eTMF system. About 24% were managing all of their clinical trial documents in an eTMF system, and 22% were using some type of shared file system.

Of the people using paper, about 45% stated that proving a solid business case was the big reason they had no implemented an ETMF system. About 40% stated they did not have enough staff, and 33% said they did not have the money.

No matter if they were using a paper or electronic system, those who responded stated that the biggest challenge to managing clinical trial documents and TMFs is the large amount of time needed to locate and track the documents. The next biggest problem is the non visibility into the status of the documents used in clinical trials.

According to the NextDocs report, people who use paper also struggle with lack of resources and a lack of ability to give their global team full access to TMF documents. Companies that are using an eTMF system said that processes that were inefficient for contributing to the electronic system was a big problem.

The survey noted that the key factors for firms using the eTMF system were:

  • Functionality in document management – 46%
  • Accessibility around the globe – 45%
  • Flexibility – 44%
  • Cost of ownership – 40%

For the end users, the biggest factors were the ease of use, ability to report missing data, and the dashboard functions.

The survey also found that saving money is a part of why people implement an eTMF, but that is not the big reason people do it. Rather, firms are worried the most about how they can measure more productivity and utilization. has a new webinar coming up on best practices in eTMFs, on Jan. 15.

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