DR. BAAL MedConsult
Research - Berlin, Berlin, Germany
DR. BAAL MedConsult Employees
DR. BAAL MedConsult Details
Consultant for Clinical Research with Medical Devices.Services offered in accordance with national and international regulations (e.g. GCP, ISO 14155, MEDDEV):• Clinical investigational plan (protocol) development • Patient informed consent development and review • Site assessment • Ethics Committee dossier preparation, submission, progress tracking • Competent Authority dossier preparation, submission, progress tracking • Investigational site initiation and training • Field technical support for investigational device usage during study procedures • Serious adverse event reporting to competent authorities for pre-market trials
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