Growth in the global electronic trial master file market can be ascribed mainly to the increased adoption of the electronic trial master file market systems. In addition, there has been a rise in the number of clinical trials along with increased partnerships between contract research organizations and biopharma companies, which is likely to boost growth of the global electronic trial master file market over the period of assessment. Furthermore, increased clinical trials and research and development activities, which are funded by biotech and pharma companies, are likely to spell growth for the market during assessment period.

In most of the cases, electronic trial master file systems are required to maintain compliance with various regulatory agencies. This file system also needs to come up with a historical look at the course of actions that have already been taken during the process of clinical trial.

Documents of clinical trial regulatory have always been paper-based and those are stored centrally in real file cabinets. With the increased penetration of the electronic and virtual systems, electronic trial master file system is gaining attention and adoption across the globe.

No two electronic trial master file systems are the same. However, these file systems must have some basic functionalities to cater to the need of management of trial master file. Some of the basic functionalities are as follows:

  • Document Uploading/Creation
  • Document Classification
  • Document Indexing
  • Document Storage
  • Comprehensive Security
  • Document QC
  • Auditability
  • Global Electronic Trial Master File Market Reporting
  • Search and Retrieval
  • Metadata

Regionally, North America is likely to account for a leading share of the global electronic trial master file market over the forecast period. Such prominence of the region is ascribed to the increased funding from the government for conducting clinical research. In addition, presence of several market players is also expected to fuel market growth in the region.

Global Electronic Trial Master File (eTMF) Market: Overview

Various organizations are deploying electronic trial master file (eTMF) as it offers large number of benefits, which has led growth in the global electronic trial master file (eTMF) market. Use of this device helps in saving money, time, and improves visibility by repairing and discovering incorrect documents. Moreover, it also saves time while preparing for audit; minimizes time to require for a new clinical site, and provide keystrokes for site activation documentation.

All these advantages have fueled growth in the global electronic trial master file (eTMF) market. Combined with this information, other ongoing trends, growth factors, opportunities and restraints are also presented in this report. These analyses will help the key participants operating in the market to take better and well-informed decisions. Primary and secondary researches have been carried to systematical and strategically present this information. 

Global Electronic Trial Master File (eTMF) Market: Notable Developments

Prominent players in the global electronic trial master file (eTMF) market are conscious efforts that will expand growth opportunities in this market.

  • PRC Clinical is now planning to use Veeva Vault eTMF as the foundation for its electronic Trial Master File services. The enabling Veeva’s eTMF services will provide multiple level manage TMF processes management for the clinical study teams and offers documents in one system, in real-time basis.
  • Altasciences, a biotechnology and pharmaceutical contract research organization opted to use Montrium’s electronic trial master file (eTMF) Connect mainly to improve compliance. Use of this service will help them in better management of their clinical trial documentation and improve collaboration with a centralized interface. With about 250 ongoing studied in Canada and the United States each year, there was a need for powerful platform.

Few other prominent players operating in this market are SureClinical,, SAFE-BioPharma Association, Paragon Solutions, SterlingBio, Montrium Inc., Phlexglobal Ltd, and Arivis AG., Advanstar Communications, Inc., Sure Clinical, Inc., Transperfect, OASIS, Veeva Systems, Mastercontrol, Inc., and Vertmarkets, Inc.

Global Electronic Trial Master File (eTMF) Market: Trends and Opportunities

With increasing clinical trials by life science organizations, there was a dire need for solution that will document crucial trials issues. Documentation of new findings including novel drug, treatment, or medical devices that are effective and safe to use by people were challenging. Thus, with the use of electronic trial master file has augmented efficiency of work and supported sharing of these documents. Moreover, eTMF solution assists clinical research group to exchange, access, and arrange clinical documents electronically from distant location with electronic devices.

Asia Pacific Offer Bestows Huge Growth Potential Owing to Developments Taking in Pharmaceutical Industry

With respect to geography, North America holds maximum share in the global electronic trial master file (eTMF) market and is likely to dominate over the forecast period. Increasing application of cloud technology in different sectors including healthcare is the key factor responsible for the dominance of North America in the global electronic trial master file (eTMF) market. North America generates largest amount of cloud traffic i.e. 1,891 EB (Exabyte) every year due to ease of use and low cost associated with cloud platform.

However, Asia Pacific is also projected to contribute in the growth of the global electronic trial master file market. This growth is attributed to the developments taking place in the pharmaceutical industry. India and China are two major regions that are making efforts in developing pharmaceutical industry. For example, in India high quality medicines are available at low price, which has fueled growth in the pharmaceutical industry. Owing to these factors,
Asia Pacific region is expected to rise hold substantial share in the global electronic trial master file (eTMF) market in the forthcoming years.

Market segmentation based on geography:

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

This report gives access to decisive data, such as:

  • Market growth drivers
  • Factors limiting market growth
  • Current market trends
  • Market structure
  • Market projections for the coming years

Key highlights of this report include:

  • Overview of key market forces propelling and restraining market growth
  • Up-to-date analyses of market trends and technological improvements
  • Pin-point analyses of market competition dynamics to offer you a competitive edge
  • An analysis of strategies of major competitors
  • An array of graphics and SWOT analysis of major industry segments
  • Detailed analyses of industry trends
  • A well-defined technological growth map with an impact-analysis
  • Offers a clear understanding of the competitive landscape and key product segments

This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.

Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:

  • Customer Experience Maps
  • Insights and Tools based on data-driven research
  • Actionable Results to meet all the business priorities
  • Strategic Frameworks to boost the growth journey

The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.

The following regional segments are covered comprehensively:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.

Below is a snapshot of these quadrants.

1. Customer Experience Map

The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

2. Insights and Tools

The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.

3. Actionable Results

The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.

4. Strategic Frameworks

The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.

The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:

1. What can be the best investment choices for venturing into new product and service lines?

2. What value propositions should businesses aim at while making new research and development funding?

3. Which regulations will be most helpful for stakeholders to boost their supply chain network?

4. Which regions might see the demand maturing in certain segments in near future?

5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?

6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?

7. Which government regulations might challenge the status of key regional markets?

8. How will the emerging political and economic scenario affect opportunities in key growth areas?

9. What are some of the value-grab opportunities in various segments?

10. What will be the barrier to entry for new players in the market?

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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