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Add common sense
to your clinical trial

ISO14155 and how medical device trials are regulated

On 26 May 2021, EU regulation 2017/745 (Medical Device Regulation, MDR) is scheduled to come into full effect, thus amending the Medical Device Directive (MDD).

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Clinical Quality Management System

A well-designed clinical investigation needs a well-designed clinical Quality Management System (QMS) as a firm basis to effectively protect subject rights, safety and wellbeing, and ensure high quality data. Additionally, a good QMS will provide maximum efficiency and flow throughout your clinical investigation instead of compromising your progress.

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Working with other experts

What clients say about us

“We are still happy with our choice to use the Common Sense Clinical QMS as a basis to set-up our own QMS. I can confirm again that the QMS is put together well and we did not run into any issues.”

Clinical Research Director Atro medical

“The clinical QMS created by CSC greatly facilitated the implementation of our clinical study. We were able to benefit from the different templates provided by CSC and adapt them to our project. The quality of the supports, in line with the latest regulatory requirements and recommendations, allowed us to move forward serenely in the management of our study.”

Clinical Project manager at Koelis

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My name is Sanne Derks and I am a medical device specialist focused on delivering high quality, no nonsense clinical services.

In need of some common sense? Give me a call or send me an e-mail.

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