Pharmacovigilance is an integral element of any medical study. The current trend towards digitalisation of non-interventional studies (NIS) not only raises questions, but also opens new possibilities for drug safety practices.
Using innovative digital technologies, modern NIS can be designed in a variety of ways and pave the way to revolutionise the early detection of adverse events.
In their book, Dipl. Inf. Philipp Petersen (Managing Director, Cross4Channel GmbH) and Dr Detlev Jakschies give an overview over the digital potential and implementation of contemporary technologies for the execution of clinical studies.
Furthermore, other relevant peripheral issues are discussed including data privacy, the HWG (German Advertising of Medicines Act), and medical devices – which inevitably becomes relevant when opening digital channels.
|Definition of clinical studies and pharmacovigilance|
|Digital non-interventional studies|
|Systematic analysis of data und pharmacovigilance|
|Digital methods of communication regarding Adverse Events (AE) messages|
|Technical security concepts|
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