Electronic Trial Master File Systems

Electronic Trial Master File Systems Market by Component (Services, Software), Distribution (On-Cloud, On-Premise), End-User - Global Forecast 2024-2030

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[193 Pages Report] The Electronic Trial Master File Systems Market size was estimated at USD 1.33 billion in 2023 and expected to reach USD 1.47 billion in 2024, at a CAGR 9.79% to reach USD 2.57 billion by 2030.

Electronic Trial Master File Systems Market
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The electronic trial master file (eTMF) leverages software and server technology to establish, collect, track, and archival essential clinical study documents. The eTMF systems are convenient for managing the large data pool collected during the trials with minimal error and no human involvement. The eTMF offers a standardized procedure for classifying and keeping track of files, photographs, and other digital content for clinical trials required for compliance with government regulatory agencies. The increasing number of clinical trials and several government initiatives for the digitalization of the healthcare sector is significantly increasing the adoption of eTMF systems with the growing need for data management and storage of documents. However, the high cost associated with installing eTMF systems and concerns regarding medical data privacy impedes the adoption of eTMF systems. In addition, to cope with increasing clinical trials, companies focus more on bringing advanced and easy-to-use software to reduce the load of huge data generated through clinical trials.

Electronic Trial Master File Systems Market - Global Forecast 2024-2030
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Regional Insights

The adoption of healthcare information technology is increasing in the United States, augmenting the need for electronic trial master file software to ease the work of huge data generated through clinical trials every year. The huge number of clinical trials taking place and increasing R&D expenditure by pharmaceutical companies are beneficial as there is a need for a suitable tool to help researchers keep track of data and store the data effectively. According to the Pharmaceutical Researchers and Manufacturers of America (PhRMA), in 2022, R&D expenditures belonging to biopharmaceutical firms were approximately USD 80 billion in the United States. In North America, increased outsourcing of clinical trials and the need for better compliance and data security measures increase the adoption of electronic trial master file (eTMF) systems. In Eastern Europe, the eTMF market is expected to grow in the coming years owing to the adoption of advanced analytics and AI technologies, increased focus on patient-centricity, and emerging markets. In Asia-Pacific, increasing outsourcing of clinical trials and the adoption of advanced technologies raised the utilization of eTMF systems.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Electronic Trial Master File Systems Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Electronic Trial Master File Systems Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • C&R Research, the Largest Korean CRO, Expands Partnership with Medidata to Enhance Their Clinical Operations.

    C&R Research, one of the largest contract research organizations in Korea, recently announced an expanded partnership with Medidata. This agreement furthers their use of Medidata's software – specifically the Electronic Trial Master File (eTMF) system. eTMF maximizes efficiency in clinical trial operations with its cloud-based technology that centralizes each trial’s documentation in one secure location. With this partnership, which was designed to enhance their clinical operations, C&R Research can utilize advanced features such as document tracking and alerts, while also satisfying government regulations through greater control over electronic audit trails. By utilizing the eTMF system experts across different laboratories can access and collaborate on documents faster. This expands C&R Research's capabilities and strengthens their presence in the clinical trial market. [Published On: 2022-11-15]

  • Anju Introduces eTMF Master for Electronic Trial Master File Management in Clinical Studies.

    Anju is proud to present the ETMF Master, a comprehensive solution for electronic trial master file (ETMF) management providing sponsors and CROs with significant efficiency and cost-savings. Developed in partnership with renowned industry stakeholders, this reliable quality management and document control system facilitates flawless data organization during clinical studies. Many organizations have already benefited from its powerful workflows that are customizable based on the client’s specific needs, allowing companies to efficiently manage files per study or product, while allowing real time access of ETMFs across multiple sites. With automated validation procedures designed to help organizations stay compliant with regulatory authorities, the ETMF Master is an indispensable tool for today's ever-evolving market of digital solutions geared towards clinical research operations. [Published On: 2022-06-20]

  • ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East.

    ArisGlobal is making headlines with their recent success in the APAC and Middle East markets for their Electronic Trial Master File Systems. Their innovative products enable customers to benefit from increased electronic content management capabilities by organizing, managing, monitoring and securely sharing all document types associated with clinical trials. This ensures that important documents are tracked accurately and remain up to date while being available in a timely manner. In addition, they feature robust functionality to meet the complex requirements of regulatory submissions. With this latest milestone, ArisGlobal continues to be a leader in the electronic trial master file system market. [Published On: 2022-04-05]

Key Company Profiles

The report delves into recent significant developments in the Electronic Trial Master File Systems Market, highlighting leading vendors and their innovative profiles. These include Advarra, Inc., Anju Software, Inc., ArborSys Group, ArisGlobal LLC, Aurea, Inc., Cereblis LLC, Clario by eResearchTechnology GmbH, Clinblocks B.V., Clinevo Technologies Private Limited, Cloudbyz, Inc., ComplianceQuest, Crucial Data Solutions, Inc., Daffodil Software Private Limited, Dassault Systèmes, DataRiver S.r.l., Dell Technologies, Inc., Ennov SAS, ethica CRO Inc., EvidentIQ Group GmbH, Flex Databases s.r.o., Florence Healthcare, Inc., Freyr Solutions, ICON PLC, IKCON PHARMA Inc., IQVIA Inc., Kivo, Inc., Laboratory Corporation of America Holdings, MasterControl Solutions, Inc., McDougall Scientific Ltd., Medrio, Inc., Montrium Inc., Navitas Life Sciences, Novotech Health Holdings, Octalsoft, OpenClinica, LLC, Oracle Corporation, PHARMASEAL, Phlexglobal Ltd. by PharmaLex Group, Prevail Infoworks, Inc., Questex LLC, Sarjen Systems Pvt. Ltd., SGS Société Générale de Surveillance SA, SimpleTrials, SMART-TRIAL ApS, SureClinical Inc., TCell Clinical Services, Techsol Corporation, TransPerfect Translations GmbH, Veeva Systems Inc., and Vial Health Technology, Inc..

Market Segmentation & Coverage

This research report categorizes the Electronic Trial Master File Systems Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Component
    • Services
    • Software
  • Distribution
    • On-Cloud
    • On-Premise
  • End-User
    • Contract Research Organizations
    • Pharmaceutical & Biotechnology Companies

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

The report offers valuable insights on the following aspects:

  1. Market Penetration: It presents comprehensive information on the market provided by key players.
  2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
  3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
  4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
  5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

  1. What is the market size and forecast of the Electronic Trial Master File Systems Market?
  2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Electronic Trial Master File Systems Market?
  3. What are the technology trends and regulatory frameworks in the Electronic Trial Master File Systems Market?
  4. What is the market share of the leading vendors in the Electronic Trial Master File Systems Market?
  5. Which modes and strategic moves are suitable for entering the Electronic Trial Master File Systems Market?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Electronic Trial Master File Systems Market, by Component
  7. Electronic Trial Master File Systems Market, by Distribution
  8. Electronic Trial Master File Systems Market, by End-User
  9. Americas Electronic Trial Master File Systems Market
  10. Asia-Pacific Electronic Trial Master File Systems Market
  11. Europe, Middle East & Africa Electronic Trial Master File Systems Market
  12. Competitive Landscape
  13. Competitive Portfolio
  14. List of Figures [Total: 22]
  15. List of Tables [Total: 280]
  16. List of Companies Mentioned [Total: 50]
The Revolutionary Electronic Trial Master File Systems that Are Reshaping the Clinical Trial Landscape
June 14, 2023
BLOG
The Revolutionary Electronic Trial Master File Systems that Are Reshaping the Clinical Trial Landscape
The fast-paced world of clinical research is adopting advanced technologies, and electronic trial master file (eTMF) systems have recently come to the forefront. The need for efficiency, speed, and accuracy in clinical development is driving the integration of eTMFs into traditional paper-based systems. Electronic trial master file systems refer to a collection of files and documents electronically stored in a centralized database in clinical trials. This state-of-the-art system enables investigators, sponsors, and monitoring teams to have access to clinical trial data instantly, which significantly reduces clinical trial timelines and costs.

Features and Benefits of Electronic Trial Master File Systems:

Electronic trial master file systems store clinical documents electronically, from early-stage protocols, informed consent forms, and regulatory files to operational data. These electronic systems offer several benefits to sponsors, investigators, and regulatory agencies in the clinical trial process. eTMFs provide higher accuracy and efficiency by eliminating the need for paper records, physically transporting, and copying documents from one place to another. Additionally, electronic trial master file systems ensure security by maintaining a central repository and allowing customizable user access. Auditing, reporting, and managing tasks are among some of the critical tasks that eTMFs support.

Importance of Interoperability in the Electronic Trial Master File Systems:

Integration of advanced technologies such as machine learning, artificial intelligence, and blockchain in the clinical setting requires the use of electronic systems that are interoperable and can exchange data safely. Interoperability refers to the ability of an eTMF system to communicate and share data electronically with different clinical systems. An interoperable eTMF system will streamline and improve clinical processes, reduce errors, and lower costs. Due to the speed and accuracy that electronic trial master file systems enable, they have become a common feature in the clinical trial landscape.

Regulations Applied to Electronic Trial Master File Systems:

Regulatory guidance documents support the use of electronic trial master file systems, including compliance with 21 CFR Part 11 and Good Clinical Practice Guidelines (ICH-GCP). Standardization such as HL7, MEDRAS, and CDISC enable the integration of data from Electronic Health Records (EHRs), Electronic Data Capture (EDC), and other clinical systems.

Future Advancements in Electronic Trial Master File Systems:

Integrating Electronic Health Records (EHRs) in clinical trials is an exciting development in the use of electronic trial master file systems. EHRs provide valuable data to support evidence-based clinical studies, and integration with eTMFs bridges the gaps in clinical trial data. The use of Artificial Intelligence in eTMFs will revolutionize clinical research. AI can support effectively analyzing vast amounts of data, thereby streamlining the overall clinical trial process and transforming the collection and management of data. Additionally, eTMFs are expected to be interoperable with other clinical systems, thus enhancing transparency, speed, accuracy, and integration in clinical trials.

Electronic Trial Master File Systems is an innovative technological advancement that is changing the clinical trial landscape. The benefits of eTMF systems are evident, including higher efficiency, speed, and accuracy. The integration of interoperability, regulations, and future advancements such as artificial intelligence and machine learning offers new opportunities for clinical development. The future of clinical research appears dynamic, and the implementation of electronic trial master file systems will be a fundamental game-changer.

Frequently Asked Questions
  1. How big is the Electronic Trial Master File Systems Market?
    Ans. The Global Electronic Trial Master File Systems Market size was estimated at USD 1.33 billion in 2023 and expected to reach USD 1.47 billion in 2024.
  2. What is the Electronic Trial Master File Systems Market growth?
    Ans. The Global Electronic Trial Master File Systems Market to grow USD 2.57 billion by 2030, at a CAGR of 9.79%
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