Investigation site management
We help you in finding the right investigation sites with a competent and motivated personnel.
We work closely with specialized study centers, hospitals and medical offices to select a site/sites with a patient population and recruitment potential that is optimal for your device. Our experts conduct site qualification visits to ensure suitability for your clinical investigation. We prepare budgets and negotiate contracts with the healthcare units.
We prepare a monitoring plan and monitor the investigation.
We make sure the study personnel are trained in the use of your device and the study protocol. Our experts keep regular contact with the sites to ensure data quality.
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Welcome to our new website!Our new and modern website offers a user-friendly experience for our customers.
Extension of the MDR transition period – do not stop working towards the certification!The European Parliament recently approved the extension of the MDR transition period. What does this mean for medical device manufacturers?
Data management in clinical investigations – Part 3: Data traceabilityData traceability is a foundational principle for clinical investigations aiming to demonstrate the performance and safety of medical devices.