NextDocs, a provider of regulated content management and compliance solutions for clinical trials, released its report, The State of Trial Master File (TMF), examining TMF management in the life sciences and pharmaceutical industry. The report, based on survey responses from more than 50 life sciences companies, reveals a large technology gap in the management of TMF.
"The life sciences industry is focusing on new strategies to drive down the cost of running clinical trials," said Zikria Syed, CEO of NextDocs. "When it comes to TMF management, half of the industry is moving rapidly to electronic Trial Master File management (eTMF) to make the process more efficient; the other half is still largely managing these essential documents manually. There is a big disparity here."
Despite widespread discussion and success with eTMF in the pharmaceutical and medical device industry, a significant number of companies still use paper to manage clinical trial documents. Nearly 30% of those surveyed still rely entirely on a paper-based, manual system. An additional 20% use a hybrid solution, with some trial documents on paper and some in an electronic system. And 22% use a shared file system, while only 24% manage all clinical trial documentation in a purpose-built eTMF system.
NextDocs conducted the survey to better understand how companies are managing trial master files. It queried respondents on the major features, obstacles and key performance metrics surrounding the implementation of an eTMF system. Although the survey revealed an increased use of electronic solutions over previous years, companies still face significant challenges managing clinical trial documentation.
The survey reported the top three challenges to managing trial master files were the time required to locate and manage TMF documents (48%), the lack of visibility into the status of clinical trial documents (35%) and inefficient processes for global teams to contribute documents (31%). Respondents using a commercial electronic trial master file (eTMF) applications reported fewer challenges in these three areas (38%, 23% and 23%, respectively).
While saving money and gaining a high return on investment were cited as primary benefits of implementing an eTMF solution (43%), the survey showed for most respondents, other benefits were just as important. Companies were concerned first and foremost with improving productivity (74%). Other business objectives included quick clinical study preparation (44%) and improved audit results (38%).
The key factors in driving eTMF adoption were document management functionality (53%), global accessibility (44%) and cost considerations (39%).
Respondents reported a lack of staff (40%) and a lack of funds (33%) among the top reasons companies hold back from implementing an eTMF solution.
"Ironically, the rationale that some life sciences companies give for delaying the inevitable introduction of eTMF—staff and budget constraints—are two of the biggest areas where the business can benefit from an eTMF: increased productivity and cost savings," said Syed.