With a network of CRAs all over Europe, we can provide high-quality, yet cost-efficient monitoring services in all regions of Europe. Our monitors have at least two years’ experience, are familiar with clinical trial management systems and other tools typically used in clinical research (eCRF, IXRS, etc.), have excellent soft skills and have profound knowledge of local and international regulations. We use CRAs located within reach of the investigational sites, so that travel costs can be kept at a minimum.
During site selection and start-up activities, our monitors ensure that site specific documents are collected in time and meet the requirements for regulatory submissions, that the investigational sites are selected according to the needs of the client and that timelines for set-up are observed.
During routine monitoring, the CRAs are in close contact with the site staff, ensure that data are entered in a timely fashion, perform SDV to the extent required, make sure that safety reporting is performed in accordance with regulations and conduct onsite visits as per your requirements. They review drug accountability or device accountability and support the site staff whenever there are any logistic or technical issues. When the database is about to be locked, they strive for swift resolution of queries and for smooth achievement of the database lock.
At study closure, they review the investigator site file to ensure that all essential documents are filed.
For medical device studies, we can also provide clinical field engineers.
+49 9872 9699027
+49 9872 9699029