Medical Devices

Over 25 years of experience enable MEDIDATA's experts to deliver research results for almost all kinds of clinical trials. We are proud to be among the very few CROs worldwide, whose range of services covers all tasks in pharmaceutical or medical device studies, also including the responsibilities of an imaging core lab (ICL). International studies are covered through strategic partnerships with two highly respected CROs.

Medical device manufacturers are facing increasing requirements on data from clinical trials data by regulatory agencies. The recent amendment to the EU Medical Device Directive, MDD 2007/47/EEC, has further tightened the requirements for performing clinical studies yielding supporting data. Thoroughly familiar with these current EC Guidelines and the corresponding implementation in German law (MPG) in accordance with ICH-GCP, we can offer distinctive know-how for clinical trials with medical devices:

• Study planning, setup, site selection
• Protocol writing and review
• Regulatory and ethics pre-study activities
• CRF/eCRF development
• Project management and logistics
• Registration support with competent authorities
• Imaging core lab facilities including QC and blind read of imaging data
• Competent authority notification
• Site management, contract management, site reimbursement
• Clinical monitoring
• Data management
• Statistical analysis
• Medical writing

Even after your commercial launch, we can assist you in meeting post-marketing surveillance (PMS) requirements. PMS studies are becoming increasingly important, especially since the latest MDD amendment, as many medical devices have been re-assigned to a higher risk category. Howeever, these studies necessitate a different approach in logistics and setup as well as ongoing efforts on data collection than pre-registration trials. Therefore, we have a dedicated PMS department at MEDIDATA enabling rapid setup and cost-efficient management of such studies.

MEDIDATA provides services for paper based, EDC-based, or hybrid PMS studies (paper CRF+EDC). As a standard, MEDIDATA sets up and maintains reporting websites.