Ethics Committee (EC) – an independent body in a Member State, consisting of healthcare professionals and nonmedical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to 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 is able to prepare submission packages for Central Ethics Committee (CEC), Local Ethic Committee (LEC) or both.
According to local requirements and local laws Biomapas Start-Up team offers to prepare and submit initial submission packages in order to start a clinical trial.
We will adapt EudraCT application form for a country (applicable only for EU countries) and prepare all other country specific templates that would be needed for any of the countries. We will coordinate essential documents preparation and will collect them from the sites.
Service package might also include full pack of documents, including prepayments to EC and RA and submission.
Response to queries which follows subsequently after the submission are fully coordinated by Biomapas team as well.