Part of performance evaluations in Europe, the USA and China is to search, collect and evaluate the available scientific literature using a systematic search approach. MARACA International can perform such a systematic review of the scientific literature and provide a performance evaluation plan and report. This report will identify the gaps in clinical evidence for your product and guide the development of a clinical study plan when needed.
When a clinical study is needed, MARACA International can help develop the Clinical study plan/protocol, manage data collection, monitor the study and generate the clinical study report. We will notify your study when needed and help write the performance evaluation chapter of your design dossier.