Based on a decade of experience with clinical quality services provided to external clients, Addomed can develop and follow a complete auditing programme as well as only particular auditing services. Addomed auditing services includes site audits, system audits, audits of CRO and audits of the clinical trial documentation. We have an experience from various audits performed for external clients for sites based in USA, UK, Europe (Belgium) different CEE countries (Russia, Croatia, Slovenia, Serbia, Macedonia).
Beside sponsor’s trainings, our QA has been trained on ISO 9001 quality system and passed several Barqa and Brookwood Academy courses. QA compliance activities included a wide variety of internal audits in Croatia, Macedonia, Slovenia and Serbia to ensure the quality, accuracy and compliance for each study. FDA site training has been done for high recruiting sites in Russia to ensure clinical study sites are FDA inspection ready.
Development and implementation of quality management systems
GCP audit, TMF audit, PV audit, internal and external (vendor) audit
FDA and/or EMA site preparation
Regulatory inspection management, including training, preparation, coordination of the inspection process, response coordination and follow-up