Everything we do at Medace is set up to support you in your First in Man Clinical study. We collaborate with a number of partners to offer everything you need for the realization of your clinical operations.
Through strong partnerships Medace can guide you in pro-actively applying some of the future requirements.
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We focus on all aspects of clinical operations including
All our cleanrooms are serviced by our team from a technical and operational point of view including annual shutdown, environmental monitoring…
GMP Personnel Qualification
In order to guarantee the expertise of staff members regarding working in GMP and cleanroom facilities, all staff members will be registered and qualified. Staff may only carry out their activities after they have been qualified to be competent for performing the relevant activities. Before starting new activities, Medace will provide new GMP and cleanroom members all necessary training and information at an upfront agreed fee. The subjects to be covered will depend on the situation.
Moving into clinical trials requires both your Manufacturing and your Clinical Quality Management System to be complete.