SOURCE: Cutting Edge Information

Cutting Edge Information

December 09, 2015 14:08 ET

Dedicated Trial Master File Teams Handle Related Quality Control Processes at 59 Percent of Surveyed Global Life Sciences Groups, According to Report by Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 09, 2015) - Life science teams often have dedicated groups for quality assurance and quality control (QC) activities. However, when it comes to performing QC checks on trial master files (TMFs), dedicated groups may not always take the lead. According to primary intelligence provider Cutting Edge Information, ownership of TMF-related quality control often depends on whether teams operate at the global, US or non-US country level.

Findings from a recent study indicate that 59 percent of surveyed global-level teams leverage the expertise of dedicated TMF structures for quality control oversight. By comparison, US groups prefer that clinical operations groups manage TMF QC duties (59 percent). Non-US country-level teams operating in either developed markets or emerging markets tend to assign TMF quality control ownership to quality assurance groups (38 percent and 29 percent, respectively).

Conducting regular quality control activities, however, is far more important than the group leading the charge.

"Teams with QC ownership should update the trial master file as soon as possible and evaluate all documents regularly," said senior research analyst Sarah Ray. "Regularly scheduled TMF review ensures that all necessary documents are in place and remain inspection-ready."

Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, 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 clinical trial master file management, please visit:

Contact Information

    Rachel Shockley
    Marketing Team Leader
    Cutting Edge Information