Dr. Baal Medconsult
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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