SOURCE: Cutting Edge Information

Cutting Edge Information

November 17, 2015 09:30 ET

Sixty-Seven Percent of Life Science Teams in the United States Outsource Some Portion of Trial Master File Management, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - November 17, 2015) - Pharmaceutical and medical device companies involve several internal groups -- including clinical operations and quality control -- to help construct accurate, comprehensive and compliant clinical trial activity records. However, when it comes to building and maintaining essential trial master files (TMFs), companies may also recruit outside expertise. According to a recent study by business intelligence firm Cutting Edge Information, sixty-seven percent of surveyed teams in the United States contract out some portion of their TMF management.

Outsourcing trends may diverge significantly, however, by region. Outside of the United States, sixty-three percent of surveyed country-level teams prefer to internally manage these documents.

"While there are some apparent regional trends, the degree to which life science teams do partner with CROs may vary depending on company needs," said Sarah Ray, senior research analyst at Cutting Edge Information. "For example, about 35 percent of all surveyed teams characterize TMF ownership as a share responsibility with third party vendors. Only 12 percent outsource the bulk of TMF responsibilities."

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, please visit

Contact Information

    Rachel Shockley
    Marketing Team Leader
    Cutting Edge Information