Current Edition

Clinical Trial Logistics: GCP as an Obstacle Rather than a Support?

Within the following white paper Dr Wolfgang Eglmeier,
Head, Center for Clinical Trials, Witten/Herdecke University,
looks into clinical trials information – from the logistics point
of view. The investigators gather these data from the patients,
and transfer the data to the sponsor, often via CROs (contract
research organisations); the sponsor – a (bio)-pharmaceutical
company, a medical device manufacturer or an academic
institution – transforms the data and provides information
derived from the data to ethical committees/IRBs (institutional
review boards) and health authorities or scientific journals for
publication; based on these data, the health authorities may
grant a marketing authorisation.