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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

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, 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
  • On the basis of region
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East
    • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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