The Growth of the Electronic Trial Master File – eTMF Market
A number of research reports have been published over the past years trying to determine the size, growth and usability of the Electronic Trial Master File – eTMF software market. What follows is a summary view of some of these reports.
Most paper-based industries and processes, even those that are highly regulated, have matured and benefited from some kind of digital transformation. Document Management software, CRM software among other categories of software have all made workplace processes far more efficient. Legal, healthcare, IT, Financial industries along with numerous other industries have all leveraged software technologies to impact efficiency and effectiveness of their processes. The pharmaceutical and biotech industry is no different.
The managing of Clinical trial regulatory documents has historically been a paper-based process. However, paper-based processes are laborious, costly and prone to errors. Providing a digital platform and strategy around the capture, management and reporting of regulatory documents will enable clinical trial stakeholders to be more productive, effective and reduce business risk throughout the regulatory compliance process. The industry-wide momentum to streamline clinical trial processes and adopt applications to improve operational efficiency continues to drive innovation. Studies show that greater efficiencies throughout the clinical trial process are reported by organizations that use eTMF applications. In fact, the number of CROs using eTMF applications has more than doubled over the past few years.
There have been a number of reports and surveys published trying to size up the eTMF market. We will focus on specific reports and highlight some of their findings. Further analysis into the eTMF market can be made by reading the reports directly.
AUTHOR: Coherent Market Insights
ABOUT THE REPORT: Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity. This report on the eTMF provides data on Size, Share, Outlook, and Opportunity Analysis of the eTMF market for a period from 2018 to 2026.
SUMMARY OF FINDINGS:
- North America is expected to exhibit high growth on the electronic trial master file (eTMF) market during the forecast period (2018-2026), due to increasing adoption of cloud-based technology for application in various sectors such as healthcare.
- Some of the major factors driving growth of the electronic trial master file (eTMF) market are the various benefits to organizations; namely time savings, saves money, and increases visibility by discovering and repairing incorrect documents quickly and also by allowing content search to be actionable, as well as saves time in audit preparation.
AUTHOR: QY Research Reports
ABOUT THE REPORT: This report focuses on the global eClinical Solutions status, including the eTMF market, future forecast, growth opportunity, key market and key players. The study objectives are to present the eClinical Solutions development in United States, Europe and China. Market Size, Status and Forecast for 2019-2025.
SUMMARY OF FINDINGS:
- The key driving factors responsible for the growth of E-Clinical trial solutions market include rising operational costs and regulatory requirements linked with clinical research studies. Additionally, favorable grants to conduct clinical trials and rising R&D expenditure by pharma-biotech organizations with enhanced IT budgets for drug advancement lend to favorable market growth for the forecast period.
- The ease of integration, quicker deployment, and flexible scalability with a fixed monthly fee offered by cloud-based models are expected to drive the demand for these solutions.
- The global eClinical Solutions market is expected to grow by a CAGR of 12.5% during the forecast period of 2019-2025.
ABOUT THE REPORT: The Veeva 2017 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 300 clinical operations professionals from around the globe.
SUMMARY OF FINDINGS:
- There is an industry wide drive toward a unified clinical model that is defined by end-to-end processes and systems, seamless collaboration among stakeholders, and greater insights across the clinical lifecycle to improve performance.
- Nearly all (99%) respondents report the need to unify their clinical applications, including CTMS, EDC, and eTMF.
- For more than half, the need to speed study execution, improve study quality, ease collaboration, and achieve greater visibility are the key drivers for adoption.
- One in three (31%) sponsors now use an eTMF application, up from 13% in 2014.
- Only 16% of sponsors say their clinical operations departments use paper for most/all TMF documents, down from 41% in 2014.
- And half of document templates are now created electronically (52%), double the number from two years ago (25% in 2015).
- Most sponsors (51%) report the need for better visibility and one-third say clinical data is tracked outside of their systems. Yet, organizations that extensively use data to improve clinical trial processes achieve greater benefits than those not leveraging data, including easier collaboration (50% to 25%, respectively), central and remote auditing (50% to 31%, respectively), and automated tracking and reporting of documents (54% to 38%, respectively).
- Nearly all (99%) respondents report the need to unify their clinical applications. The top three most important drivers for unifying clinical applications are faster study execution (65%), improved study quality (63%), and cost savings (59%). Most (76%) say unifying their applications will drive improvements in three or more areas.