AXG quickly identifies appropriate principal investigators from its investigators database;
We thoroughly evaluate sites based on their experience, interest in clinical trials, eligible patients number, staff workload and other sponsor requirements;
AXG regulatory team effectively submits new clinical studies to Ukrainian authorities having good knowledge of local legislation and productive communication with SEC and CEC experts during all study duration.
We provide full services of study submission which include protocol and other clinical trial material review, preparation of initial submission package as well as consequent study submissions such as Amendments, IBs, first subject first visit notifications, annual reports, safety and final reports.
AXG safety team ensures duly and timely AE/SAE reporting and safety reports submission to regulatory authorities and investigators in accordance with ICH GCP and Sponsor requirements.
AXG Line Manager is responsible for providing all AXG staff with all relevant clinical trial trainings and supervision of clinical trials quality conduct during their duration;
Regular co-monitoring visits, documentation and reports review, control during audits and inspections are an integral part of AXG working process which is supported by Line Manager and Local Project Managers.
Site visits: initiation, monitoring, close-out, emergency, motivational;
Full range of monitoring services: rate of enrollment supervision, subject eligibility review, pre-visit letters, monitoring reports and follow up letters timely composition, effective site personnel support, SAE/AE reporting guidance, ensuring Protocol, ICH GCP and local laws compliance and other.
Two qualified freelance translators which work with us during several years provide qualified translation and back-translation services of all clinical trial documentation.
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