Global Market Outlook on eTMF

High growth of the global electronic trial master file (eTMF) market can be attributed to growing number of clinical trials across the globe and government regulations mandating the use of eTMF for clinical trials.To implement eTMF system, companies need to implement a cost effective, ready-to-use and completely secure eTMF solution that effectively addresses the challenges involved in managing clinical trial regulatory documents.

eTMF market

  • The global electronic trial master file (eTMF) market is estimated  to be $51.7 million in 2017. This market valuation is supported by a high CAGR of 14.0 percent from 2012-2018
  • The eTMF is intended to electronically manage all trial documentation, images, and other digital content to maintain regulatory compliance and respond to interactions with regulators
  • With evolving regulatory guidelines supporting the increased use of eTMF and other electronic content management solutions to achieve higher levels of regulatory compliance and reduce business risk, the industry is actively transitioning away from paper

Challenges and Benefits –eTMF Technology

Challenges Addressed

  • Reduced business risk: systems provide confidence that you have met agency regulatory compliance requirements
  • Enhanced document quality: automated systems have been proven to make fewer errors than manual paper handling processes; ability to implement automated quality control processes
  • Improved team productivity: sharing, viewing documents anytime, anywhere from any device is faster than manual paper retrieval
  • Reduced auditing and reporting costs: automated reporting and retrieval of ECM based systems can significantly reduce auditing and reporting labor and travel costs


  • Growth in Regulations: State, Federal and industry regulations continue to grow and evolve
  • Risk Management: Significant risks and penalties for non-compliance, including fines, and customer lawsuits
  • Product Quality: Enhanced product quality through easier audits and management ,accelerate Clinical Trials. Electronic document sharing with clinical trial stakeholders such as, Investigators, agencies, and clinical research centers can help resolve issues faster and accelerate clinical trial milestones
  • Cost Savings: Save document mail and overnight courier costs, save document physical storage costs, save administrative staff document handling and management costs
  • Time Savings: Anytime, anywhere access to documents helps business operations move forward faster than manual, paper-based processes