The core activity of AE Consulting is the consulting and support of clinical trials in the medical technology industry. The company offers customized services such as study accompaniment, consulting and support for clinical trials to ensure customer satisfaction and to design study projects in a time- and cost-efficient manner.
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Support and monitoring of clinical studies in medical technology; clinical monitoring in line with ICH-GCP, selection of investigation sites, documentation, authority submissions, and training of study personnel.
Consulting and support for clinical trials
Consulting and support for the planning and conduct of clinical trials; flexible project oversight, takeover of studies already underway, organization of investigator meetings, and maintenance of the site file and trial master file.
Post-Market Clinical Follow-Up (PMCF)
Support in the area of Post-Market Clinical Follow-Up for medical devices after CE approval; collection of clinical data on safety and performance in accordance with the MDR.
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