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.
Regulatory Authorities (RA) according to ICH guideline includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as Regulatory Authorities (RA).
Following local laws for countries’ within Biomapas coverage list, we will prepare initial submission packages (including all documents required) and all amendments for Regulatory Authorities and Ethics Committees (Central Ethics Committee (CEC), Local Ethic Committee (LEC) or both).
Biomapas offers highly experienced PhD level professionals to create master Informed Consent Form (ICF). Our team will also adapt master Informed Consent Form (ICF) received from Sponsor according to local requirements (including translations, page limitations and other country-specific requirements).
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.
Response to queries which follows subsequently after the submission are fully coordinated by Biomapas team as well.