SOURCE: Cutting Edge Information

Cutting Edge Information

July 13, 2016 08:30 ET

US Pharma Companies Plan to Increase Percentage of Electronic Documents to 76% by 2020

Life science companies are converting paper trial master file (TMF) documents into electronic formats

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 13, 2016) - A study published by Cutting Edge Information found that the goal for US pharmaceutical companies is to increase their percentage of electronic documents from an average 38% to 76% by the year 2020.

On a global scale, surveyed clinical teams estimated that an average of 54% of their trial master files (TMFs) are electronic, but they expect this balance to shift to 88% by 2020. However, country-level teams in emerging markets are anticipated to undergo the most dramatic change. On average, Brazil and India plan to increase their distribution of electronic and paper documents from 8% and 92% to 77% and 23%, respectively.

According to the study, Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, many life science groups have begun using electronic case report forms and electronic informed consent documents. Back in 2013, the FDA declared that official copies of source data, which is an essential TMF document, can be either paper or electronic. Fast forward two years and the FDA also provided guidance for use of electronic informed consent within companies' clinical studies.

"The predicted increase of electronic TMF files can be partially explained by FDA, MHRA and EMA guidance," said Sarah Ray, senior research analyst at Cutting Edge Information. "However, companies were hesitant to make this transition because they considered wet ink signatures a necessary part of their TMF. However, the MHRA and EMA agencies stepped in and offered guidance in favor of reducing industry reliance on wet ink signatures, making companies more comfortable with the change."

To learn more about outsourcing patterns and other trends associated with TMF management, check out Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices. The report, available at, 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 Cutting Edge Information's clinical reports, visit

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