Global Electronic Trial Master File (eTMF) Systems Market is expected to witness a healthy CAGR of 12% by 2027 - Revolutionizing Clinical Trials

Medi-Tech Insights: Growth in the number of clinical trials, a surge in the volume of data generated and an increase in the number of eTMF system users are some of the key factors driving the growth of global eTMF systems market.


An electronic Trial Master File (eTMF) is a content management system for the Bio-Pharma industry which includes protocols, strategies, and tools used throughout the lifecycle of the clinical trial. An eTMF digitally captures, shares, and stores the essential documents and content generated in a clinical trial.

Key Benefits Offered by eTMF Systems Drives the Adoption of eTMF Systems Market

Post Covid-19 pandemic, the number of clinical trials and volume of data generated increased exponentially, which in turn has fueled the adoption of eTMF systems by Bio-Pharma companies. The eTMF systems give real-time visibility of the clinical trial data and activities conducted at scattered sites across the world. The benefits of adopting eTMF are increased business efficiency, speedup timelines, reduced cost and risk.

For instance,

  • In June 2022, Anju Software Inc., announced the introduction of its new cloud-based eTMF product. The product will expedite the collaboration between CRO’s, sponsor and sites to manage the clinical data efficiently in a regulatory-compliant environment.

Resurgence of eTMF Systems Market Post Co-vid 19 Pandemic

The Covid-19 Pandemic has triggered a change in execution of clinical trials. Due to travel bans and lockdowns, virtual clinical trials were initiated by Bio-Pharma companies by adopting remote patient monitoring, telehealth, wearable devices and apps to ensure the patient safety. The large number of clinical trials conducted for rapid development of vaccines during the pandemic had also burdened the healthcare sector. With rise in the number of trials and its data, there was a shift from manual TMF systems to eTMF systems, for seamless management of data in decentralized clinical trials. The other factor which had set in motion this shift was the clinical data retention regulation policy to maintain the data for 25 years by the Sponsors/CRO’s.

North America is Expected to Hold a Larger Market Share in the eTMF Systems Market

From a geographical perspective, North America holds a larger market share of the eTMF systems market. This can be mainly attributed to the growing number of clinical trials & volume of data generated, favourable funding environment to support clinical trials, well-developed healthcare IT infrastructure, and presence of several key players in the region. However, the Asia-Pacific region is expected to witness strong growth in electronic trial master file systems market during the upcoming years due to flourishing Biopharma industry, growing outsourcing of clinical trials in the region, and rapid development of vaccines by Biopharma industry due to Covid-19 Pandemic.

Competitive Landscape Analysis: eTMF Systems Market

Some of the key and established players operating in the electronic trial master file systems market are listed below: -

  • Veeva Systems
  • Aris Global LLC
  • Master Control Inc.
  • Montrium
  • Clinevo Technology
  • Oracle Corporation
  • Phlexglobal
  • Transperfect
  • Aurea Software
  • Labcorp (Covance Inc.)
  • Sureclinical

Organic and Inorganic Growth Strategies Adopted by the Market Players to Establish Their Foothold in the global eTMF Systems Market

All the major players operating in the eTMF systems market are adopting both organic and inorganic growth strategies such as launching new products/technologies, collaborations, and acquisitions to garner a higher market share.

For instance,

  • In February 2023, TransPerfect Life Sciences announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management.

The global eTMF systems market is a growing market and is projected to gain a consistent momentum in the upcoming years with growing adoption of eTMF systems, increasing R&D investments by pharma-biotech companies, favorable government funding & grants to support clinical trials, and aggressive organic and inorganic growth strategies followed by the key market players. However, inadequate trained professionals and clinical data privacy are some of the upcoming challenges that are likely to hamper the global growth of the eTMF systems market.

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eTMF Systems Market