Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Solutions
  2. Products
  3. Insights
  4. About
  5. Careers
  6. Contact Us
MAIN/search
MAIN/Solutions
Solutions/
SOLUTIONS
  • Research & Development
  • Real World Evidence
  • Commercialization
  • Safety & Regulatory Compliance
  • Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
THERAPEUTIC AREAS

Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

LEARN MORE
Harness the power to transform clinical development

Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.

Research & Development Overview
Research & Development Quick Links
Real World Evidence. Real Confidence. Real Results.

Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.

REAL WORLD EVIDENCE OVERVIEW
Real World Evidence Quick Links
See markets more clearly. Opportunities more often.

Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

COMMERCIALIZATION OVERVIEW
Commercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.

Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.

COMPLIANCE OVERVIEW
Safety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.

When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.

TECHNOLOGIES OVERVIEW
Technology Quick Links
MAIN/Products
Products/
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
REAL WORLD PRODUCTS

CASE STUDY

"Data in a Day

LEARN MORE
MAIN/Insights
Insights/
BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS
THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

SEE LATEST REPORTS

INSTITUTE REPORT

"Global Trends in R&D 2024

READ MORE

EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

Learn more

WHITE PAPER

"DCTs Deliver Big ROI

LEARN MORE

WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

LEARN MORE
MAIN/About
About/
FEATURED INNOVATIONS
  • IQVIA Connected Intelligence™
  • IQVIA Healthcare-grade AI™
  • Human Data Science Cloud
  • IQVIA Innovation Hub
  • Decentralized Trials
  • Patient Experience powered by Apple
WHO WE ARE
NEWS & RESOURCES

INVESTOR RELATIONS

"Visit our investor relations site for more information.

LEARN MORE
Unlock your potential to drive healthcare forward

By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.

LEARN MORE
IQVIA AI is Healthcare-grade AI

Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.

LEARN MORE
Your healthcare data deserves more than just a cloud.

The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.

LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships

The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.

LEARN MORE
Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

LEARN MORE
IQVIA Patient Experience Solutions powered by Apple

Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.

LEARN MORE
MAIN/Careers
Careers/
WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

LEARN MORE
LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

LEARN MORE

WE’RE HIRING

"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

SEARCH JOBS
MAIN/Contact Us
Contact Us/
White Paper
eTMF and the eClinical Universe
How electronic trial master files work with other eClinical Systems to help you meet regulatory requirements
Jul 18, 2019
  • Library
  • eTMF and the eClinical Universe

Get instant access

Download

The completeness, timeliness and reliability of your eTMF system depends upon it receiving the correct documents as they become available, regardless of where they originate. This white paper provides multiple insights to help ensure that the eTMF will operate accurately and efficiently within the eTMF universe.

The electronic Trial Master File (eTMF) is an increasingly important eClinical technology used to manage the set of essential documents required for every clinical trial.

The eTMF is a specialized form of an Electronic Document Management System (EDMS) optimized to manage the processes around creating or uploading clinical trial documents and completing the workflow processes needed to finalize, secure and archive them. While small Phase 1 trials may only have a few documents, large Phase 3 or Phase 4 trials require tens of thousands of documents. As a result, better systems and increased automation offer the opportunity for meaningful cost and time savings. The eTMF contains a wide variety of documents that the regulatory authorities have determined are necessary to allow the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated – often augmented by additional documents required by the sponsor. Each trial has its own specific set of required documents based on the trial details such as the nature of the investigational product, the countries in which the trial is being conducted, or the phase of the study. Completeness and accuracy of the TMF is a significant regulatory requirement, and regulatory agencies conduct audits of TMFs by direct examination of sponsors’ eTMF systems.


THE eCLINICAL UNIVERSE

The eTMF exists within a universe of eClinical systems that manage trial aspects such as logistics, safety, data collection and analysis, legal, and many others. Often, these systems are the sources of data or documents needed for the Trial Master File. An efficient and compliant eTMF must work in harmony with a variety of eClinical systems in order to contain the required information. Provides an overview of the eClinical systems that may provide data and documents to eTMF, or in a few cases, require access to documents stored in eTMF. Furthermore, these documents must be available in a timely manner. In recent guidance, the EMA has stated “The TMF should to be up to date, with documents placed in the TMF in a timely manner with the aim to maintain the TMF “inspection ready”. Furthermore, if documents required in the eTMF aren’t available in a timely manner, the system study and site milestones may be delayed. For example, site initiation and regulatory green light depend on receiving final clinical trial agreements. The electronic Trial Master File (eTMF) is an increasingly important eClinical technology used to manage the set of essential documents required for every clinical trial.


DOWNLOAD TO LEARN MORE

Related solutions

eTMF

Manage trial master files from planning through archive with solutions designed to improve workflow efficiency, promote collaboration, and support compliance.

Digital Site Suite

Increase transparency, improve communications and reduce administrative burden for all clinical trial stakeholders.

IQVIA Technologies

Combine data science, technology, and analytics driven by artificial intelligence to support new efficiencies and business insights -- without additional capital investment.

Contact Us