Electronic trial master file (eTMF) is a formalized method for arranging and storing documents, pictures, and digital content of pharmaceutical clinical investigation that might be required for compliance with government organizations. An eTMF stores documents and contents electronically on a computer server or cloud, eliminating the need for organizational framework for filing paper document. Almost all organizations involved in clinical trial activity interacts or supports compilation of eTMF. The trial master file (TMF) not only contains adequate and accurate data, but also is synchronized for evaluation by inspectors, and it shares data with clinical study team members both internally and externally. The most common features of eTMF software are content integration, control, storage, and elaborating on the data related to clinical trials.

Factors Driving Growth of the Global Electronic Trial Master File (eTMF) Market

One of the major factors driving growth of the electronic trial master file (eTMF) market is various benefits offered by use of this to organizations. Electronic trial master file saves time, saves money, and increases visibility by discovering and repairing incorrect documents quickly and also by allowing content search to be actionable. Electronic trial master file saves time in audit preparation; site activation documentation is distributed within a few keystrokes; and also reduces time to establish a new clinical site.

Life science companies that are engaged in clinical trials are required to document important issues of trials. Clinical trial is primary research where researchers find out if a new treatment, new drug, diet, or medical device is safe and effective to be used by people. The complexities in management of clinical trials due to involvement of stake holders and vendors, handling proper documentation is always a challenge. Electronic trial master file boosts work efficiency and supports sharing of documents, helps in resolving issues, prevents delay, and speeds up work flow process. Electronic trial master file system benefits clinical research team to electronically access, exchange, and manage clinical documents remotely using any electronic device. Electronic trial master file system is economical as it saves overnight courier cost, document storage costs, and staff document handling and managing cost.

Factors Restraining Growth of the Global Electronic Trial Master File (eTMF) Market

Lack of skilled professionals is a major factor hampering growth of the global electronic trial master file (eTMF) market. This is owing to eTMF system being content management system for the pharmaceutical industry it requires skilled professionals for handling. If unskilled professionals handle the eTMF system documents may get misplaced or replace, and due to this organizations may suffer high maintenance cost.

Regional Analysis of Electronic Trial Master File (eTMF) Market

On the basis of region, the global market for electronic trial master file (eTMF) is segmented into North America, Europe, Asia Pacific, Latin America, Middle East, and Africa.

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. This is owing low cost associated with the use of cloud platform and ease of use. According to Cisco, in 2016, North America generated the most cloud traffic (1,891 Exabyte (EB) annually), followed by Asia Pacific (908 EB manually) and Western Europe (718 EB manually). By 2021, North America will generate the most cloud traffic (3.6 Zettabyte (ZB) manually), closely followed by Asia Pacific (2.3 ZB manually) and Western Europe (1.5 ZB manually).

Asia Pacific is expected to exhibit significant growth owing increasing adoption of eTMF in the pharmaceutical industry. Furthermore, emerging economies in the region such as China and India are major growth engines. For instance, India is a manufacturing hub and offers high quality, low priced medicines, and this has led to high growth of the pharmaceutical industry. According to India Brand Equity Foundation (IBEF), the pharmaceutical sector was valued at US$ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4% over 2015-2020 to reach US$ 55 billion in India.

Key players in Global Electronic Trial Master File (eTMF) Market

Some of the key players involved in electronic trial master file (eTMF) market are CareLex.org, Paragon Solutions, Phlexglobal Ltd, SAFE-BioPharma Association, SterlingBio, SureClinical, Montrium Inc., and Arivis AG. Sure Clinical, Inc., OASIS, Transperfect, Veeva Systems, Vertmarkets, Inc., Mastercontrol, Inc., Advanstar Communications, Inc.

Global Electronic Trial Master File (eTMF) Market: Taxonomy

The global electronic trial master file (eTMF) market size is segmented on the basis of deployment type, application, and region:

On the basis of deployment type On Premise Cloud



On basis of product type Software Hardware



On basis of end user Pharmaceutical companies Contract Research Organization Biopharmaceutical Research Institutes

