Archive

At Pharmbiotest, we ensure the secure and compliant storage of clinical trial documents in our dedicated, temperature-monitored archive. In accordance with Good Clinical Practice (GCP) and applicable regulatory requirements, essential study records are maintained for the required retention periods.

Our archive is designed to preserve trial documentation for at least 25 years after the study’s completion, as mandated by GCP, and for a minimum of 2 years after the last approval of a marketing application in an ICH region. Documents are stored safely until there are no pending or anticipated applications, or longer if required by regulations or agreed with the sponsor.

With strict adherence to international and local guidelines, our storage procedures are governed by Standard Operating Procedures (SOPs) to ensure data integrity, confidentiality, and regulatory compliance.