SOURCE: Cutting Edge Information

Cutting Edge Information

November 12, 2015 12:11 ET

Life Science Companies Project Heightened Use of Electronic Platforms to Support Trial Master Files, Finds New Cutting Edge Information Study

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 12, 2015) - Nov. 12, 2015 - As part of good clinical practice (GCP), life sciences teams must develop trial master files (TMFs) and maintain these documents well after the product launch window. Historically, these files were comprised largely of paper-based documents. However, according to a new study by Cutting Edge Information, surveyed global teams report that each of their current TMFs is 54 percent electronic-based. And, that portion is expected to increase to 88 percent 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.

Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, available at http://www.cuttingedgeinfo.com/research/clinical-development/trial-master-file/, guides clinical executives through trial master file management practices. Report highlights include:

  • Best practice recommendations and projected costs associated with implementing an eTMF platform.
  • Data on dedicated trial master file teams' staffing levels and necessary training structures
  • Metrics detailing clinical trial master file quality control processes, including the number and timing of checks performed on site and sponsor-level documents.

For more information about clinical trial master file management, please visit http://www.cuttingedgeinfo.com/research/clinical-development/trial-master-file/.

Contact Information

  • CONTACT:
    Rachel Shockley
    Marketing Team Leader
    Cutting Edge Information
    919-433-0211