General
Required skills and Qualifications for Medical Writers
An essential, and often overlooked part of the work on clinical trials is medical writing. It is involved at the start and end of the
Clinical Research Insights
An essential, and often overlooked part of the work on clinical trials is medical writing. It is involved at the start and end of the
The new MDR requires small to midsize medical device companies to take over sponsor responsibilities for their clinical trials. Some companies find they cannot take
ICH GCP and ISO14155 defines the term monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is
“Is it equivalent?” As a medical device manufacturer, you are very aware of MEDDEV 2.7/1 rev. 4. from 2016. Following this document when planning and
ICH GCP and ISO14155 defines the term monitoring as “The act of overseeing the progress of a clinical trial, and of ensuring that it is
René Pulles, Lead Regional Operations Manager in Nijmegen Why open a new branch office in the Netherlands? The answer is clear. The Benelux area is home
There are approximately 1,300 new studies registered annually in the Central and Eastern Europe (CEE) region. Poland, Hungary, and the Czech Republic take the largest
NEED SITES FOR YOUR CLINICAL TRIAL?LOOK NO FURTHER!THE CEE REGION IS THE RIGHT PLACE FOR YOUR NEXT STUDY. Core benefits when working within the
The protection of personal data in clinical trials is a major concern considering for instance the health data of patients. In the European Union this
Selecting the most suitable countries and sites for your clinical trial is a major step towards getting your study started off right. It also ensures