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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
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Americas
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Asia & Oceania
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Americas
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Europe
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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
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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.
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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.
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Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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IQVIA Connected Intelligence™
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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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"At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
VIEW ROLESWhite Paper
IQVIA eTMF: Response to EMA Reflection Paper on GCP Compliance
TMF Related Elements
Jul 18, 2019
Get insights into the key eTMF-related points of the paper and review recommendations to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance and inspection.
Recently, the European Medicines Agency (EMA) issued a draft “Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials”.
This paper is the first published framework for eTMF for an entire region. EMA states that the paper is provided in response to the numerous questions they have been receiving regarding TMF / eTMF, as well as in response to inspection findings.
EMA states that the aim of the paper is to “set out the requirements for the TMF as covered in directives and guidance and to give recommendations to assist organizations in maintaining a TMF that facilitates trial management, GCP compliance and inspection. The paper also addresses archiving of the TMF, clarifying retention times and gives some recommendations regarding destruction of paper documentation.”
IQVIA has studied the paper to ensure that we comply with the key points. We also used the paper 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.
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Related solutions
Customer Engagement
Orchestrated Customer Engagement, or OCE, goes beyond traditional CRMs by embedding real-time intelligence into user workflows so commercial teams can personalize, optimize, and improve their HCP engagements across all channels.