2022 ACC/AHA Guideline for the Diagnosis and Management of ...



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Electronic Trial Master File (eTMF) Market Soars With 14.0% CAGR, Projected To Reach Over US$ 190 Million By 2027

The global electronic trial master file (eTMF) market paints a promising picture of exponential growth from 2017 to 2027. Notably, the market has already experienced significant expansion between 2012 and 2016, a trend expected to intensify in the years leading up to 2027. Projections indicate that the global eTMF market will surpass a valuation of US$ 190 million by the end of the assessment year.

Future Market Insights has analyzed numerous aspects of the electronic trial master file (eTMF) market and has included actionable insights in a systematic manner in its new research publication titled "Electronic Trial Master File (eTMF) Market: Global Industry Analysis (2012-2016) and Opportunity Assessment (2017-2027)". The extensive research study on the eTMF market portrays various facets of the global market such as trends, opportunities, value chain analysis, competitive landscape, drivers, restraints, and regional research along with key recommendations that can be viewed by the reader to achieve his/her strategic objectives in the long run.

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The research study also covers future market projections with respect to value for a period of ten years starting from 2017 to 2027. The comprehensive analysis of each segment and sub-segment of the global market portrays a real-time picture of the global market scenario.

Asia Pacific excluding Japan shows high potential for growth in the electronic trial master file market:Several key players are focusing on the Asia Pacific excluding Japan (APEJ) region in order to tap the emerging economies in this region. The main advantage of this region is its high potential for growth as compared to matured economies. Several end-use industries are showing interest in this region owing to which the supply-side players are focusing their attention on APEJ to gain business expansion.

Electronic trial master file (eTMF) market in Asia Pacific excluding Japan (APEJ) region is expected to grow at the highest pace in the coming years to register a stellar CAGR of 17.6% and is estimated to reach a valuation of about US$ 18 Mn by the end of the period of assessment, thus becoming the third largest region in the eTMF market after Western Europe.

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Global Electronic Trial Master File (eTMF) Market: Competitive Scenario:

The research study includes a dedicated chapter on competitive scenarios that deal with various key players involved in the eTMF market. Analysis of aspects such as SWOT analysis, geographical reach, strategies, product portfolio, expansion plans, mergers and acquisitions, key developments, distribution channel analysis, etc., of the key players have been covered in this study. Companies like Veeva Systems, Medidata Solutions, Inc., MasterControl, Inc., Data Reduction Systems Corporation, Transperfect Global Inc., Aurea, Inc., Phlexglobal Ltd., Arivis AG, Wingspan Technology Inc., and Montrium Inc., are profiled in this section.

Electronic Trial Master File (eTMF) Market Segmentation:

By Component

By Deployment

By End User

By Functionality

  • Clinical Operations
  • Records Management
  • Auditing
  • IT Operations
  • By Region

  • North America
  • Western Europe
  • Eastern Europe
  • APEJ
  • Japan
  • Latin America
  • MEA
  • About Future Market Insights (FMI):

    Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 5000 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.

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    Electronic Trial Master File (eTMF) Systems Market To Reach USD 3.78 Billion By 2030 At Healthy CAGR Of 12.9%

    icn789034 icnSNS INSIDER 300X300

    Electronic Trial Master File (eTMF) Systems Market Scope & Overview

    Electronic Trial Master File (eTMF) Systems Market to Gain Higher Momentum due to Globalization of Clinical Trials and Advancements in Cloud Technology

    As per the SNS Insider report, the Electronic Trial Master File (eTMF) Systems market was assessed at USD 1.43 billion in 2022. Projections indicate it is anticipated to attain a valuation of USD 3.78 billion by 2030, demonstrating a CAGR of 12.9% during the forecast span from 2023 to 2030.

    An Electronic Trial Master File (eTMF) system is a cutting-edge digital solution designed to streamline and manage the complex documentation and records associated with clinical trials in the field of healthcare and pharmaceutical research. This advanced technology replaces traditional paper-based processes, offering a comprehensive and efficient approach to storing, organizing, and accessing trial-related documents.

    Major Players Listed in the Report:

    Aurea, Inc., Master Control Inc., Covance Inc., Ennov, Oracle, Veeva Systems, Care Lex, Trans perfect, ePharma Solutions, SureClinical Inc., Phlex global, Database Integrations, Inc. And Other Players

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    Market Analysis

    The electronic trial master file (eTMF) systems market is experiencing robust growth driven by a confluence of factors that are reshaping the landscape of clinical research and trial management. The life sciences industry is subject to stringent regulatory guidelines, which require the meticulous management of trial documentation to ensure patient safety and data integrity. ETMF systems provide a centralized platform for maintaining, tracking, and auditing trial documents, assisting organizations in meeting regulatory requirements efficiently. Data breaches and integrity issues can have severe consequences in clinical trials. ETMF systems incorporate robust security features such as encryption, access controls, and audit trails to safeguard sensitive trial information, ensuring data confidentiality and integrity.

    Impact of Recession

    The impact of a recession on the electronic trial master file (eTMF) systems market is a complex interplay of challenges and opportunities. While budget constraints and delayed trials can pose challenges, the emphasis on efficiency, outsourcing trends, regulatory compliance, and innovation can open up avenues for growth. ETMF solution providers that are agile, responsive to market demands, and capable of offering value during tough economic times are more likely to navigate the challenges and emerge stronger on the other side.

    Segmentation Analysis

    The amalgamation of cloud-based eTMF solutions and the dominance of Contract Research Organizations (CROs) signifies a transformative era in the electronic trial master file (eTMF) systems market. The dynamic interplay between these segments promises heightened efficiency, collaboration, and data integrity, redefining the standard for excellence in clinical trial management. This evolution not only drives operational excellence but also lays the foundation for accelerated drug development, leading to improved patient outcomes and advancements in medical science.

    Electronic Trial Master File (ETMF) Systems Market Segmentation as Follows:

    By Delivery Mode

  • Cloud-based eTMF
  • On-premise eTMF
  • By Component

    By End-User

  • Pharmaceutical & biotechnology companies
  • Contract Research Organizations (CROs)
  • Other end-users
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    Regional Status & Analysis

    In North America, particularly in the United States, the electronic trial master file (eTMF) systems market is flourishing due to the presence of a robust pharmaceutical and biotechnology sector. The region's stringent regulatory environment, led by the Food and Drug Administration (FDA), has propelled the adoption of eTMF systems to streamline clinical trial processes and ensure compliance. The Asia-Pacific region, with countries such as China, Japan, and India, is rapidly emerging as a significant player in the eTMF systems market. The region's growing pharmaceutical and biotechnology industries, coupled with the rising number of clinical trials being conducted, have resulted in a heightened demand for eTMF solutions.

    Conclusion

    The future of the market looks promising, driven by technological advancements, the need for regulatory compliance, globalization of trials, and the growing recognition of the value these systems bring to clinical research. Vendors that can offer innovative, adaptable, and user-friendly solutions while staying abreast of evolving industry trends will be well-positioned to thrive in this dynamic market.

    Frequently Asked Questions

    What is the projected outlook for electronic trial master file (eTMF) systems market growth?

    – The global market to reach USD 3.78 billion by 2030, demonstrating a CAGR of 12.9% during the forecast span from 2023 to 2030.

    What are the major factors influencing the electronic trial master file (eTMF) systems market?

    – The market is being propelled by a dynamic interplay of factors that respond to the evolving landscape of clinical trials and trial management.

    Who are the leading players in the electronic trial master file (eTMF) systems market?

    – Aurea, Inc., Master Control Inc., SureClinical Inc., Care Lex, Trans perfect, ePharma Solutions, Covance Inc., Ennov, Oracle, Veeva Systems, Phlex global, Database Integrations, Inc.

    Table of Content

    Chapter 1 Introduction 

    Chapter 2 Research Methodology

    Chapter 3 Market Dynamics

    Chapter 4. Impact Analysis (COVID-19, Ukraine- Russia war, Ongoing Recession on Major Economies)

    Chapter 5 Value Chain Analysis

    Chapter 6 Porter's 5 forces model

    Chapter 7 PEST Analysis

    Chapter 8 Electronic Trial Master File (ETMF) Systems Market Segmentation, By Delivery Mode

    Chapter 9 Electronic Trial Master File (ETMF) Systems Market Segmentation, By Component

    Chapter 10 Electronic Trial Master File (ETMF) Systems Market Segmentation, By End User

    Chapter 11 Regional Analysis

    Chapter 12 Company profile

    Chapter 13 Competitive Landscape

    Chapter 14 Use Case and Best Practices

    Chapter 15 Conclusion

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    Tags: ETMF Systems, Electronic Trial Master File System, ETMF Systems Market, Electronic Trial Master File Systems Market, Electronic Trial Master File (eTMF) Systems Market, ETMF Systems Market Share, ETMF Systems Market Size, ETMF Systems Market Growth, ETMF Systems Market Trends


    Kivo GO Offers An Intuitive Document Management Solution For Life Sciences

    Kivo, provider of an intuitive Document Management Solution for life sciences, is launching Kivo GO, a unified platform for emerging life sciences teams who need to work together efficiently across all functions while maintaining compliance and security.

    "When it comes to advancing a new treatment, time to market is critical—both for the patients who need it and the company sponsoring it," said Kivo's CEO, Toban Zolman. "However, these smaller regulatory, clinical, and quality teams often don't have the budget or admin resources for an 'enterprise' solution—so they lose a shocking amount of time trying to manage documents and processes in a compliant way."

    Kivo offers these teams a fit-for-purpose solution to accelerate their timelines with the launch of Kivo GO—a compliant collaboration solution with built-in modules for every function including RIM, eTMF, and QMS.

    Key benefits of the Kivo solution include:

  • Fast, simple, intuitive: Kivo GO allows regulatory, clinical, and quality teams to work together easily—including with their partners and vendors—all in the same secure workspace. Functional modules such as eTMF, RIM, QMS, an eCTD viewer, and more are all part of the same platform—no integrations required.
  • Designed (and priced) for smaller teams: Scaling teams no longer need to choose between patchwork systems or a big-budget solution. With Kivo, everything is included for one affordable price—fast setup, lifetime updates, real-time support—and everyone on the team can access the same workspace and functional modules.
  • Best-in-class security and compliance: Kivo GO is Part 11 Compliant and Validated—with no local installation required and built-in support for Single Sign-On. Kivo is a fit-for-purpose, cloud-based system with automatic guardrails and audit trails to safeguard data and keep everyone in compliance.
  • New quality management (QMS) features: The launch includes the expansion of Kivo's QMS capabilities, with new modules for SOPs and Controlled Documents, Training, CAPAs, Vendor Management, Audits, and more. These all leverage the templates, workflows, reporting, and project management built into the Kivo GO platform.
  • Several Kivo customers—including Hyloris Pharmaceuticals and Ventus Therapeutics—have been taking advantage of these new features prior to public launch and finding significant value in the combined platform.

    The Kivo GO platform also extends to vendors and partners, such as CROs and regulatory consultants. By leveraging Kivo across their sponsor projects, these services providers can standardize their process and project management—working more efficiently and consistently with their sponsor teams, according to the company.

    Kivo GO is available immediately, with more information available at Kivo.Io.

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