Full service for observational studies (non-interventional studies, post-marketing surveillances) has been offered by MEDIDATA GmbH since the company’s early days for a variety of indications. Among these services are planning and legal advice, preparation of study documents, central monitoring, data management, and biometrical services. Tasks are conducted in accordance with MEDIDATA’s - or if applicable and requested – with sponsor’s SOPs.

As with our other departments, MEDIDATA’s Observational Study department has passed numerous audits in recent years. Studies are designed as either paper-based, as EDC or as hybrid studies (paper CRF + EDC).

As a standard, MEDIDATA sets up and maintains reporting websites. These put web-based information at sponsors’ fingertips, e.g. by instantaneous display of recruitment status and the progress of other, defined activities over the course of a study.