Since Phase IV clinical trials aim at assessing certain aspects of the current drug use (e.g. confirming the benefit-risk analysis, new combinations, use of technology for manaing drug intake, mandated by authorities), it is key to define a protocol and study, which is well manageable for sites and patients. Our established processes coordinated by an experienced Project Management team ensure a streamlined study execution to evaluate the efficacy and safety in the long run and to detect any rare or long-term adverse effects over a much larger patient population than it was possible during Phase I-III clinical trials.
Phase IV trials are generally designed to test the drug in “real world” setting of the daily clinical practice while including a novel intervention or certain aspects for observation. Thus protocols with “wide” treatment schemes are often required. By means of our proprietary digital systems such as our Electronic Data Capture (EDC) system, data can be controlled for timeliness, accuracy, and completeness. Our risk monitoring, combining on-site, online and central monitoring enables us to guarantee safety and smooth running of each trial. Last but not least we constantly provide comprehensive knowledge and experience by all of our departments to cover the different demands during Phase IV trials.