We keep medical device clients up to date with the safety aspects of their product. Providing accurate review, documentation, and summary collection of AE/SAEs is one of our standard measure. Reports are composed from case report forms of clinical trials, triage, evaluations, follow-ups etc. and ensures timely reporting to the Sponsor and Competent Authorities.
GCP-Service compiles all the necessary documents for expedited reporting internationally. We provide case narratives and take care of document submissions to Competent Authorities, Ethic Committees, and Investigators.