Submissions

Prior to the start of clinical research, the research must be submitted to and approved by reviewing and regulatory bodies such as Ethics Committees (EC) and other competent authorities. For all single-center and multi-center studies, CTCM can provide support with the submission, including the formation of the study dossier, submission of the study dossier to the review committee and/or competent authority and answering their questions. In addition to approval from the EC, local feasibility and Board of Directors approval must also be arranged for each participating center. CTCM is also the right partner for this. Finally, CTCM can support you during the research in obtaining approval of a study amendment, or notifications to authorities to comply with legal obligations such as periodic progress and safety reports. 

CTCM has extensive knowledge and experience of Dutch legislation and regulations and carries out submissions in the Netherlands itself. For foreign submissions, CTCM coordinates the submission process and uses an extensive partner network.