Study: Long-term eTMF maintenance essential for life science companies
As part of good clinical practice (GCP), life sciences teams must develop trial master files (TMFs) and maintain the documents well after the product launch window. Historically, such files were comprised largely of paper-based documents. According to a new study by Cutting Edge Information, however, surveyed global teams report that each of their current TMFs is 54% electronic-based. And that portion is expected to increase to 88% by 2020.
The study found that paper-based TMFs may not be conducive to external inspections. Rather than being able to easily sort through document submissions, regulators reviewing paper-based files may have to sift through a multitude of boxes to evaluate the completeness, accuracy and compliance of a company’s TMF materials.
“Use of electronic-based TMFs has helped companies to increase team-wide document accessibility while reducing the amount of space necessary to store finalized TMFs,” said Sarah Ray, senior research analyst at Cutting Edge Information. “Companies must realize, however, that while the end result of eTMF platforms may alleviate some of the stresses associated with TMF management and review, the conversion process may be time-consuming and, at times, unnecessarily complex.”
Updating paper documents to an electronic platform may pose a challenge as the process is more time-intensive than building new TMFs in an electronic system. Furthermore, some document types may prove more cumbersome than others. To overcome the challenges associated with eTMF platforms, many surveyed teams prefer to execute eTMF strategies in waves. For example, teams may start by building new TMFs into an electronic system as part of a paperless pilot program, before updating paper documents from older studies.