We are an independent service-provider company founded in 2004 and with the registered place of business in Germany. Our main business areas are EU regulatory affairs and clinical research. In particular, our services include clinical trial organization, study conduct and monitoring according to EN ISO 14155 and GCP-ICH guidelines as well as Clinical Evaluations in the sense of Annex X, MDD 93/42/EEC and MEDDEV 2.7.1.
Clinical data can be obtained from several sources like clinical trials, market observation reports from the manufacturer as well as studies reported in the scientific literature with the device in question or very similar devices. The evaluation of clinical data is the process by which clinical data from all selected sources (literature, results of clinical trials and others) is assessed and analysed. The outcome of this process is a report which includes a conclusion on the acceptability of clinical risks and side effects when weighed against the clinical benefits of the device. The report shall also demonstrate whether the available clinical data are sufficient to establish conformity with the MD directives. High risk devices, in particular, if intended for new indications or incorporating new materials do in most cases require a clinical trial under consideration of the EN ISO 14155 standard and the legal ordinance on clinical trials in Germany (Verordnung über klinische Prüfungen von Medizinprodukten – MPKPV).
Management and design of clinical trials (according to EN ISO 14155, GCP).
Preparation of Clinical Evaluation reports.
Literature search and search reports.
Literature evidence analysis.