ICS – The only all-round service for studies in IVD
ICS (in.vent Clinical Services) belongs to in.vent Diagnostica GmbH, the Europe’s leading experts for the ethically sound procurement of human biomaterial (inventdiagnostica.de).
ICS was founded with respect to the major challenges for the European diagnostics industry that arise with the implementation of the EU regulation 2017/746 on in vitro diagnostic medical devices (IVDR 2017/746).
in.vent’s 20 years of experience as CRO, manufacturer, study director, and monitor, and in ethical and legal considerations are now focused within ICS. The result is a holistic all-round service for IVDR-compliant diagnostic studies and more.
Our services range from ethical considerations and sample procurement to the complete Performance Evaluation (Performance Evaluation Plan, Analytical and Clinical Performance Studies, Performance Evaluation Report) and all the way to CE-marking and Post-Market Surveillance; with just one contact you have everything covered.
Due to our company-own study site and our well-trained personnel we have absolute control over all steps of pre-analytics of our samples which is usually one of the main error sources in clinical and diagnostic studies. In case that our study site does not suffice to procure the clinically defined samples for your study we activate our tight network of international partners. The monitoring of external study sites could then also be conducted by us.
The processing and measurement of samples as well as the biostatistical evaluation will be performed in our laboratory. During large-scale projects that exceed the capacity of our lab we profit from our numerous highly competent cooperation partners.
Naturally, everything needs to be recorded in study protocols, performance evaluation plans, and reports which will write for you according to current guidelines.
All of this is embedded in a quality management system which is ISO 9001:2015 and ISO 13485:2016 certified.
Let us discuss the specific demands for your projects together! With ICS you will be able to meet them.