Survey Reveals Technology Gap in Managing Clinical Trial Documentation
Report on Trial Master Files (TMF) Shows Growing Software Adoption, but Many Pharmaceutical Companies are Lagging
CONSHOHOCKEN, Pa., Oct. 9, 2013 /PRNewswire/ — NextDocs, a leading provider of regulated content management and compliance solutions used in clinical trials today released its first report examining the state of Trial Master File (TMF) management in the life sciences and pharmaceutical industry. The State of Trial Master Files report, based on survey responses from over 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, Chief Executive Officer of NextDocs. “When it comes to Trial Master File (TMF) management, half of the industry is moving rapidly to electronic Trial Master File management or 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 of 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 percent of those surveyed still rely entirely on a paper-based, manual system. An additional 20 percent use a hybrid solution, with some trial documents on paper and some in an electronic system. Roughly a quarter (22 percent) use a shared file system while only 24 percent manage all clinical trial documentation in a purpose-built eTMF system.
NextDocs conducted The State of Trial Master File survey to better understand how companies are managing trial master files. The survey queried respondents on the major features, obstacles and key performance metrics surrounding the implementation of an electronic trial master file (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 that the top three challenges to managing trial master files were (1) the time required to locate and manage TMF documents (48 percent reporting), (2) the lack of visibility into the status of clinical trial documents (35 percent reporting), and (3) inefficient processes for global teams to contribute documents (31 percent reporting). Respondents that use 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 are often cited as primary benefits of implementing an eTMF solution (43 percent reporting), the survey showed that for most respondents, other benefits are just as important. Companies are concerned first and foremost with improving productivity (74 percent reporting). Other important business objectives include quick clinical study preparation (44 percent reporting) and improved audit results (38 percent reporting).
The key factors in driving eTMF adoption were document management functionality (53 percent), global accessibility (44 percent) and cost considerations (39 percent).
What holds companies back from implementing an eTMF solution? Respondents report that a lack of staff (40 percent reporting) and a lack of funds (33 percent reporting) are among the top reasons.
“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.
Earlier this year, NextDocs released the State of SharePoint in Life Sciences report based on an in-depth survey with more than 100 leading life sciences and pharmaceutical companies. That report detailed the major technology platform shift in the life sciences industry away from legacy document management systems towards modern, open-standard regulated content management solutions. Nearly 37 percent of life sciences companies have reported replacing or beginning to replace their legacy document management technologies in favor of regulated content management software. That was up from 22% the previous year.
Later this year, NextDocs will release a report providing detailed benchmarks on the scalability and performance of regulated content management and compliance solutions, a first for the life sciences industry.
NextDocs is a global leader in providing regulated content management and compliance solutions to life sciences organizations. NextDocs provides solutions for electronic trial master files (eTMF), regulatory submissions, standard operating procedures (SOP) and quality management systems (QMS). These solutions enable businesses in highly regulated industries to achieve compliance with the FDA and other agencies while automating processes, improving efficiency and dramatically reducing costs. NextDocs has delivered over 100 deployments with FDA regulated customers including five of the ten largest pharmaceutical companies and two of the largest clinical research organizations (CROs). NextDocs has won numerous awards including the Microsoft Life Sciences Partner of the Year award four years in a row. All NextDocs solutions are 100% browser-based and can be deployed in the cloud or on premise. For more information visit www.nextdocs.com.