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CRO Wiki: Core Knowledge on In Vitro Diagnostics

From IVDR and performance studies to ISO 13485 – our CRO Wiki covers the most important terms, processes, and regulatory fundamentals of in vitro diagnostics, as well as the validation of companion diagnostics (CDx).

Here you will find IVD and CDx terminology explained at a glance – grounded in expertise, presented in plain language, and drawn directly from the practice of a specialist CRO.

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A person wearing blue gloves and a white lab coat places a test tube into a rack, surrounded by other test tubes in a companion diagnostics laboratory setting.
Companion Diagnostics: requirements for CDx briefly explained
What are Companion Diagnostics (CDx)? Find out why they are a cornerstone of personalised medicine and what requirements they need to meet.
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A scientist in a contract laboratory, wearing a lab coat, gloves, and safety glasses, looks through a microscope in a laboratory filled with equipment and bottles on the table.
Contract laboratory briefly explained
What is a contract laboratory and what does it do? Find out when and why working with a contract laboratory adds value for scientific analyses and measurements.
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A woman in a green lab coat and blue gloves types on a laptop at a CRF lab workstation, while another person in similar attire works in the background near laboratory equipment.
CRF briefly explained
How is study data collected and secured? Learn what constitutes a CRF (Case Report Form) and which requirements apply to validation and data protection.
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Three CRO scientists wearing white lab coats and safety glasses stand smiling in a bright, modern laboratory, with shelves and equipment visible in the background.
CRO briefly explained
What does a contract research organisation do? Learn more about the role and responsibilities of a CRO – especially for in vitro diagnostics (IVDs).
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Two men sit at a table indoors, discussing dmids documents in front of a laptop. One holds papers while the other has glasses in hand. A woman stands outside in the background, talking on her phone.
DMIDS briefly explained
What is the DMIDS? Learn more about the BfArM’s platform for device and IVD registration, study submissions and regulatory data exchange.
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EUDAMED briefly explained
What is behind the EU database for medical devices? A concise summary of modules, current status, and how to use it.
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A person holding a pen reviews and marks documents spread out on a desk, including papers with text, graphics, a QR code, and references to ISO 20916. The person's face is not visible.
ISO 20916 briefly explained
What does ISO 20916 require for IVD studies? Get an overview of the key requirements this international standard sets out for study organisation.
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Abstract image with a blue background featuring several curved, darker blue stripes sweeping upward from the bottom right, reminiscent of the structured pathways often seen in notified bodies’ processes, creating a dynamic, modern look.
Notified Bodies briefly explained
What are Notified Bodies? Learn about their role and responsibilities in the EU market access process for medical devices and IVDs.
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A woman stands beside a seated man in an office, pointing at a computer monitor while he uses a mouse, suggesting collaboration or discussion about sample size calculation on the screen.
Sample size calculation briefly explained
What is sample size calculation? Find out why getting sample size right is crucial for efficient resource allocation and reliable study results.
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A person wearing red and black gloves opens a container of test tubes inside a frosty laboratory freezer, ensuring proper sample storage. Frost covers the surfaces, indicating cold storage conditions.
Sample storage briefly explained
Why is sample storage critical for sample integrity? Learn how stable temperature ranges, redundant systems, and continuous monitoring ensure reliable results.
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