Global Electronic Trial Master File (eTMF) Systems Market By Component (Software, Services), By Delivery Mode (Cloud-Based, On-Premise), By End-User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs)) By Region, and Key Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2021-2031

An electronic trial master file is a specialized content management system that is used to manage clinical documents across the lifecycle of a clinical trial.

For the most part, eTMF systems are required to maintain compliance with respective regulatory agencies as well as present a historical look at the actions that have been taken over the course of a clinical trial. Clinical trial regulatory documents have historically been paper-based documents stored centrally in physical file cabinets. However, through the proliferation of electronic systems, eTMFs are gaining widespread adoption.

Typically, all organizations who engage in clinical trial activity are required to interact or support the compilation of the Trial Master File (TMF). Core users of eTMF applications are typically responsible for research & development or information technology within their respective organizations, and are usually accountable for the maintenance of existing clinical systems, consolidating systems for improved cost-effectiveness, as well as looking to replace inefficient legacy systems for Clinical Trial Management purposes.

Organizations today are operating at incredible speeds to remain competitive and gain an edge in this market.

Clinical trial stakeholders now expect to access, exchange and manage clinical documentation electronically, at any time, from anywhere, and on any device. As the use of electronic systems has increased within the workplace, organizations are now moving towards managing their TMF electronically to take advantage of increased data quality and regulatory compliance that comes with such a change.

eTMF systems will continue to evolve to support the ever-developing nature of clinical trials and Trial Master Files. Systems will begin to integrate to present not only documents but also data that can help document and trace events within a clinical trial. TMF completeness algorithms will become more and more sophisticated with study design and events being taken into account when calculating completeness

Finally, an eTMF will start to deviate from being a simple repository and will play an important role in driving clinical processes, improving clinical planning and empowering a risk-based approach to clinical trials.

Detailed Segmentation

This market is segmented on the basis of  – Component, Delivery Mode, End-User, and Region.

By Component

• Software
• Services

By Delivery Mode

• Cloud-Based
• On-Premise

By End-User

• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Other End Users

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa

Market Dynamics

The rapid development of COVID-19 vaccines may lead more drug developers to increase the speed and agility of their operations by adopting electronic Trial Master File (eTMF) systems. These systems manage critical documents that detail the story of a given clinical trial. In the case of COVID-19 vaccines, eTMF systems tell a dramatic tale.

In 2020, the COVID-19 pandemic took center-stage and made individuals rethink life as they knew it. With so many lives at stake, the pharmaceutical industry was forced to be more proactive and innovative than ever before. With all eyes squarely on pharma and medicine, individuals waited anxiously to see just how this industry would react.

Increasing funds being allocated for IT services in various healthcare facilities may also accelerate market growth prospects.

Concerns regarding the lack of funding being allocated for administrative enhancements in various healthcare facilities is a major factor that is expected to hinder the market growth of this industry. A lack of skilled professionals needed to operate a eTMF System may also hamper the economic growth of this market.

Key players:

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

Recent Developments

• Veeva Systems, a U.S. provider of cloud-based software for the life science sector has announced a partnership with document inspection software provider GlobalVision to accelerate document development and approval processes.
• ArisGlobal LifeSphere eTMF boosts collaboration in clinical research by supporting new Trial Master File Standards
• Phlexglobal, this industry’s most advanced AI-powered TMF automation eTMF allowing customers to take advantage of double-digit time savings with a 95% accuracy rate.

For the Electronic Trial Master File (eTMF) Systems Market research study, the following years have been considered to estimate the market size: