Ethics Committee Initial Submissions
The Ethics Committee (EC) is an independent body in a Member State, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety, and wellbeing of human subjects involved in a trial.
Additionally, they provide public assurance of that protection by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.
Depending on the country, our team can prepare submission packages for Central Ethics Committee (CEC), Local Ethics Committee (LEC), or both. According to local requirements and local laws, the Biomapas Start-Up team offers to prepare and submit initial submission packages to start a clinical trial.
We adapt EudraCT application forms for various countries (applicable only for EU countries) and prepare all other country-specific templates that you would need for any of the member states. We coordinate essential documents preparation and will collect them from the sites. The service package might include a complete pack of documents, including prepayments to EC and RA and submission. Response to queries that follows subsequently after the submission is fully coordinated by the Biomapas team as well.