RESEARCH TRIANGLE PARK, NC–(Marketwired – June 28, 2017) – Life science firms are converting trial master file (TMF) documents into electronic formats, with 88% of surveyed global teams planning to shift to eTMFs by 2020, according to a study published by industry intelligence provider Cutting Edge Information.
Data from the study, Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, revealed that the goal for U.S. clinical teams is to increase their percentage of electronic trial master files, or eTMFs, from an average of 38% to 75% by the year 2020. Surveyed clinical teams from the developed markets of the European Union (EU) estimate that an average of 45% of their TMFs are electronic currently, but they expect this balance to shift to over 75% by 2020.
However, country-level teams in emerging markets are anticipated to undergo the most dramatic change. On average, clinical teams from Brazil and India plan to increase their distribution of TMFs from 8% electronic and 92% paper documents to 77% electronic and 23% paper documents by 2020.
“Across the life sciences industry, clinical teams are increasingly moving toward the use of electronic trial master files,” said Sarah Ray, senior research analyst at Cutting Edge Information. “Once fully developed, these solutions will help reduce the paper associated with companies’ TMF files and increase teamwide accessibility.”
Although many pharmaceutical companies have begun using electronic case report forms and electronic informed consent documents, some companies still remain reluctant to make this transition. Cutting Edge Information’s study found that surveyed clinical teams may struggle with incorporating eTMF solutions with existing platforms because they consider wet ink signatures as a necessary part of their TMF.
However, FDA, MHRA and EMA agencies have stepped in and offered support for the use of digital signatures in lieu of wet ink signatures, making companies more comfortable with the change. Back in 2013, the FDA noted that official copies of source data — an essential TMF document — can be either paper or electronic. In 2015, the FDA also provided guidance for use of electronic informed consent within companies’ clinical studies.
Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, explores clinical team structures, responsibilities, as well as other trends associated with TMF management. The report, available at https://www.cuttingedgeinfo.com/product/trial-master-file-benchmarking/, 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 https://www.cuttingedgeinfo.com/product-category/clinical-development/.
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Elio Evangelista
Senior Director of Commercialization
Cutting Edge Information
[email protected]
919-403-6583
