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What is a CRO and why do you need one?

- by Amanda Ball

Working with a CRO can make the difference between your IVD development leading in the market or missing it entirely.

This month we’re highlighting ARC’s role as a full service CRO for clients so you can better understand the breadth of our service and how we can support your next product development from lab to market.

Let’s start by clarifying what’s meant by a CRO.  It’s a Contract Research Organisation that provides clinical trial (clinical investigation for medical devices and clinical performance study for IVD medical devices) management services for the pharmaceutical, biotech, and medical device industries.

Although there are different types of CROs and with particular sector expertise, typical CRO services include regulatory affairs, site selection and activation, recruitment support, study monitoring, data management, trial logistics, biostatistics, medical writing and project management.

In a clinical investigation, CROs are hired by sponsors to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor’s behalf.

The main role of the CRO is to plan, coordinate, execute, and supervise the processes involved in the development and execution of a clinical investigation, being a central contact point between the sponsor and other trial stakeholders (e.g. ethics committees, regulatory agencies, vendors, and hospitals).

CROs are key players in clinical research, since they have the knowledge and the capabilities needed for the proper development and conduct of a clinical study. They help sponsors by reducing their workload, while ensuring trial quality and compliance with national and international regulations.

In summary, employing the services of a CRO make a huge difference to the success of a clinical trial. Sponsors should carefully assess the specific needs of their projects and look for the CRO that best meets their technical requirements and budget.

Find out more about ARC’s CRO offering or get in touch to discuss how we can support your next development.

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Amanda Ball
Article written by Amanda Ball

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