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What Is a Contract Research Organisation (CRO)?

A Contract Research Organisation (CRO) is a specialist service provider that conducts research on behalf of external clients. CROs support clients (sponsors) with the planning, conduct, analysis and reporting of studies and take responsibility for defined tasks – from study planning and set-up to monitoring, data management and the study report. In general, CROs cover a broad range of study types: from clinical trials for medicinal products (CTR) and clinical investigations for medical devices (MDR) to analytical and clinical performance studies for in vitro diagnostics (IVDR).

What Does an IVD Contract Research Organisation Do?

An IVD contract research organisation provides specialised support for the development of in vitro diagnostics. It works in accordance with the IVDR and ISO 20916 (clinical performance studies using human specimens) and therefore differs from CROs working in the pharmaceutical sector. To support IVD manufacturers across all phases of the IVD lifecycle, specific processes, standards, and templates are established. Staff are trained and experienced in collecting clinical and analytical performance data.

Important: If the sponsor commissions a CRO, the sponsor is still required to oversee the external organisation and remains ultimately responsible for the quality and integrity of the study (see also ISO 20916, section 5.1).

Looking for a CRO to support your study? We'd love to hear from you.

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Sabine Radiske, Founder & Managing Director / CEO

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CRO: Contract Research Organisation

CTR: Clinical Trials Regulation

IVDs: In vitro diagnostics

IVDR: In Vitro Diagnostic Regulation

ISO: International Organisation for Standardisation

MDR: Medical Device Regulation

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