Overview


According to FutureWise analysis the market for electronic trial master file is expected to reach US$ 4.21 billion by 2031 at a CAGR of 12.92%.

A trial master file in electronic form (digital content) is called an electronic trial master file (eTMF). It is a type of content management system for the pharmaceutical industry, which provides a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials, which may be necessary for compliance with government regulatory agencies. Clinical trial regulated content is managed through strategies, methods, and tools throughout its lifecycle. Clinical trial content management is facilitated by using an eTMF system that combines software and hardware. Regulations require that eTMF systems that store clinical trial content electronically must include the following components: Digital content archiving, security and access control, change controls, audit trails, and system validation. Clinical trial master files provide a systematic way to manage, organize, and store documents, images, and other content related to clinical trials.

The system saves time, money, and also detects and repairs erroneous documents, increasing the demand since it is an ideal system for saving time during audits as well as providing keystrokes regarding site activation documentation. The ETMF system provides a host of benefits that contribute to rapid market development. In the context of increasing number of clinical trials, it is becoming increasingly difficult to store findings such as novel drugs, treatments, and medical devices. Therefore, many organizations are opting for electronic trial master files, which are efficient and easy to share. Clinical trial master file (eTMF) systems integrate software and hardware components to manage clinical trial data in the most efficient manner. As a result, clinical trial data can be streamlined in a digital form that is easy to store and retrievable by dissimilar users, resulting in easy accessibility and reducing the cost associated with administrative and manual data maintenance operations. Clinical trial documents are collected and managed in a centralized repository using electronic trial master files. It reduces the administrative burden associated with clinical trials by streamlining processes, automating information transfer, and streamlining processes associated with clinical trials.

FutureWise Market Research has instantiated a report that provides an intricate analysis of Electronic Trial Master File Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.

According to the research study conducted by FutureWise research analysts, the Electronic Trial Master File Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.

  •  Paragon Solutions Inc
  •  Ennov Inc
  •  Veeva Systems Inc
  •  Phlexglobal Ltd
  •  AureA Inc
  •  SureClinical Inc
  •  LabCorp
  •  MasterControl inc
  •  TransPerfect Global Inc
  •  Montrium Inc

(Note: The list of the major players will be updated with the latest market scenario and trends)

By Component

  •  Software
  •  Services

By Deployment

  •  On-Premises
  •  Cloud

By End-user

  •  Sponsors
  •  CRO
  •  Others

By Functionality

  •  Clinical Operations
  •  Records Management
  •  Auditing
  •  IT Operations

By Region

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

  •  Tier 1 players- established companies in the market with a major market share
  •  Tier 2 players
  •  Emerging players which are growing rapidly
  •  New Entrants

  •  Growth prospects
  •  SWOT analysis
  •  Key trends
  •  Key data-points affecting market growth

  •  To provide with an exhaustive analysis on the Electronic Trial Master File Market By Component, By Deployment, By End-user, By Functionality and By Region.
  •  To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  •  To evaluate and forecast micro-markets and the overall market
  •  To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  •  To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

  •  We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  •  The customization Mobility Care offered are free of charge with purchase of any license of the report
  •  You can directly share your requirements/changes to the current table of content to:sales@futurewiseresearch.com

Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.   Electronic Trial Master File Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Electronic Trial Master File Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Electronic Trial Master File Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Electronic Trial Master File Market, By Component Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Software
        2. Services

  • 8.   Electronic Trial Master File Market, By Deployment Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. On-Premises
        2. Cloud

  • 9.   Electronic Trial Master File Market, By End-user Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Sponsors
        2. CRO
        3. Others

  • 10.   Electronic Trial Master File Market, By Functionality Historical Analysis and Forecast 2023-2031 (USD Million)
    •   1. Clinical Operations
        2. Records Management
        3. Auditing
        4. IT Operations

  • 11.   North America Electronic Trial Master File Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2023-2031

  • 12.   Latin America Electronic Trial Master File Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2023-2031

  • 13.   Europe Electronic Trial Master File Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2023-2031

  • 14.   Asia Pacific Electronic Trial Master File Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2023-2031

  • 15.   Middle East and Africa Market Analysis 2017-2022 and Forecast 2023-2031 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2017-2022
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2023-2031

  • 16.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 17.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. Paragon Solutions Inc
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Ennov Inc
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Veeva Systems Inc
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Phlexglobal Ltd
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. AureA Inc
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. SureClinical Inc
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. LabCorp
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. MasterControl inc
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. TransPerfect Global Inc
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
         10. Montrium Inc
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview

  • 18.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the healthcare regulations initiated by
                  administrations
        5. The overall economic slowdown of the developing and developed nations

  • 19.   FutureWise SME Key Takeaway Points for Client
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