RESEARCH TRIANGLE PARK, NC–(Marketwired – August 30, 2016) – Pharmaceutical regulatory agencies are requesting greater access to drug companies’ trial master files (TMFs). But only half the pharmaceutical industry have dedicated TMF teams in place to manage the process, according to research published by Cutting Edge Information.

Data analysis shows that 51% of surveyed companies’ developed market teams have these dedicated TMF groups in place. In 88% of cases, surveyed global, US and developed market teams look to their clinical operations departments for TMF management. However, clinical operations and dedicated TMF groups are not the only players involved in managing trial master file processes. Many companies involve multiple groups in trial master file management, making communication amongst these teams essential.

The study, Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, found that 45% of surveyed pharmaceutical companies’ utilize data management groups to manager their TMF processes and 37% of groups include clinical development teams. Surprisingly, only 35% of surveyed teams involve quality assurance and regulatory affairs groups. Quality assurance and quality control are essential for ensuring that the TMF has all the necessary documents and is error-free. Regulatory affairs are normally involved to offer insights from regulatory agencies and to confirm that the trial will provide data useful for earning market authorization.

“More than 20% of the surveyed teams also involve IT, contract management, quality control, records management, medical affairs, and compliance,” said Sarah Ray, senior research analyst at Cutting Edge Information. “It is extremely important that all aspects of TMF management work together and communicate end goals. This plays a big role in the success rate of clinical trials.”

To learn more about team structures and responsibilities, as well as other trends associated with TMF management, check out Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices. The report, 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.
• Benchmarking 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 http://www.cuttingedgeinfo.com/library/clinical-development/.

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Contact:
Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information
[email protected]
919-403-6583