SOURCE: Cutting Edge Information

Cutting Edge Information

June 08, 2016 08:34 ET

By 2020, Global Distribution of Electronic TMF Documents Is Projected to Increase 63% Over 2015

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 08, 2016) - Moving forward, the transition from paper-based to electronic documents will remain a vital component of trial master file (TMF) strategy. Among surveyed global clinical and regulatory groups, the average projected increase in use of electronic TMF files from 2015 to 2020 is 63%, according to a recent study by clinical development benchmarking firm Cutting Edge Information.

The study, Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, also found that in developed markets, affiliate teams project a 71% increase toward electronic TMF (eTMF) files by 2020. Emerging markets project the greatest shift toward eTMF files by 2020, projecting an 863% increase in their use.

Life sciences companies must prepare for a number of potential regulatory audits and inspections after completing clinical trials and submissions. Preparations for audits are very different between paper-based and electronic filing systems. Teams with traditional paper-based TMFs may need to consolidate all trial materials from multiple sites or countries into a single location in advance of a regulatory inspection. Furthermore, Cutting Edge Information's benchmarking study found that electronic filing systems have made audit preparations much easier.

In the beginning, some surveyed companies weren't ready to transition to electronic platforms. These companies believed signatures shouldn't be done electronically for their TMF. Recently MHRA and EMA agencies have both approved and encouraged reducing industry reliance on ink signatures.

"Electronic filing systems allow auditors and inspectors to condense their work into a much shorter time frame," said senior research analyst Sarah Ray. "Once companies implement eTMF systems, audit timelines should reduce from a matter of months to as short as two weeks."

Challenges do come along with eTMF systems. When trial documents are transferred to digital systems, they contain information that isn't necessary for audits. Companies have to not only train inspectors to use their eTMF systems, but also they must limit their access to these incomplete or proprietary files.

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/.

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