Observational Studies

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.

MEDIDATA provides the following services for paper based, EDC-based or hybrid observational studies:

Planning and legal advice

• Development of study plans, CRFs, statistical analyses plans and other documents
• Preparation of CRFs: Layout, prepress activities and control of press work
• Announcement to and notification of authorities

Project management and central monitoring

• Placement tracking and payment handling
• Study hotlines, phone monitoring services
• Quality checks and tracking of completed CRFs
• AE/SAE, ADR/SADR handling
• Generation of status reports
• Internet status reports pages (see further details in section 1.3)
• Distribution of documents and CRFs to investigators
• Medical review of CRFs

Data management

• Data entry (optionally including double data entry and verification)
• Data validation, query generation and tracking of queries
• Coding of adverse events and medications
• Management of adverse events

Biometrical services

• Preparation of statistical analyses plans
• Descriptive and inferential statistical analyses and graphics, including site specific sub-analyses in comparison to overall results
• Generation of biometrical statements / study reports and preparation of results for conference abstracts and journal submissions