The Clinical Trial Submission group is represented by a PhD (biology) with more than 8 years experience in Clinical Development, including 3 years experience in submission of clinical trials to Ethics Committees and Competent Authorities, supported by an expert group of 4 trained and experienced Study Coordinators (covering also expertise for CEE countries) and supported by appropriate administrative assistance. This unit centralizes all activities concerning regulatory applications for clinical trials in order to offer our clients a competent and efficient fulfilment of the increasing regulatory requirements before, during and after conduction of clinical trials. The group has permanent access to a regulatory intelligence database covering all European countries and US.
- support, preparation, conduct and follow-up of clinical trial submissions to Competent Authorities and Ethics Committees including Germany, Austria and Switzerland
- identification of country-specific documents required for clinical trial submissions
- preparation of application forms in close cooperation with the project team and sponsor
- review and quality check of submission documents
- creation of submission dossiers (for foreign submissions a core dossier is provided by the Clinical Trial Submission group which is completed in cooperation with the local clinical monitor)
- submissions to Ethics Committees and Competent Authorities (including local authorities, if applicable) referring to initial applications, substantial amendments, adding of new sites and investigators and other modifications
- submission of End of Trial notifications
- time-tracking of regulatory timelines
- being contact partners for Ethics Committees and Competent Authorities
- collection and provision of regulatory information concerning approvals of clinical trials
- implementation and maintenance of Accovion DRA SOPs according to actual regulations and guidelines
