Digital Site Suite
Increase transparency, improve communications and reduce administrative burden for all clinical trial stakeholders.
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Americas
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Asia & Oceania
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A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
- Adriatic
- Belgium
- Bulgaria
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- Deutschland
- España
- France
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- Hungary
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- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
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Research & Development
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Real World Evidence
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Commercialization
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Safety & Regulatory Compliance
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Technologies
LIFE SCIENCE SEGMENTS
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THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
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- Pediatrics
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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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 OverviewResearch & 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 OVERVIEWReal 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 OVERVIEWCommercialization 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 OVERVIEWSafety & 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.
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COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTSFEATURED INNOVATIONS
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IQVIA Connected Intelligence™
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IQVIA Healthcare-grade AI™
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IQVIA AI Assistant
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Human Data Science Cloud
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IQVIA Innovation Hub
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Decentralized Trials
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Patient Experience Solutions with Apple devices
WHO WE ARE
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NEWS & RESOURCES
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.
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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.
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Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
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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.
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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.
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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.
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IQVIA Patient Experience Solutions with Apple devices
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
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Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
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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 JOBSWhite Paper
IQVIA eTMF: Response to MHRA Good Clinical Practices Guide
TMF Related Elements
Jul 18, 2019
This compliance position paper focuses on Chapter 10 of the guide, "Trial master file and archiving". It provides insights on how to comply with legislative requirements and gives recommendations on how effective TMF management can be implemented.
The Guide was published based on feedback from stakeholders, who felt that there was a lack of comprehensive and authoritative guidance on how the clinical trial regulations, and in particular GCP principles, should be implemented in practice.
This compliance position paper focuses on Chapter 10 of the guide, “Trial master file and archiving”, which covers the legislative requirements and gives recommendations on how effective TMF management can be implemented. The move to electronic records is also discussed in this chapter.
IQVIA has studied the guide to ensure that we comply with the key points. We also used the guide to enhance our product roadmap to include important requests from the regulators. The remainder of this paper provides insight into the key eTMF-related points of the paper and how IQVIA eTMF complies with or supports those requirements.
Much of this chapter was later incorporated into the European Medicines Agency (EMA) draft “Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials”. As IQVIA has issued a position paper on compliance with the Reflection Paper (“IQVIA eTMF: Response to EMA Reflection Paper on GCP Compliance”), this paper only addresses elements unique to the MHRA GCP Guide.
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Related solutions
eTMF
Manage trial master files from planning through archive with solutions designed to improve workflow efficiency, promote collaboration, and support compliance.