SAN MATEO, Calif.–(BUSINESS WIRE)–January 19, 2021– InClin, Inc., a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney Australia, today announced the publication of a manuscript entitled: “The New Norm: A Global Virtual GCP Preapproval EMA Inspection” in Issue #154 January 2021 edition of Quasar, the Research Quality Association’s (RQA) quarterly journal.
The article describes how the European Medicines Agency (EMA) and sponsor collaborated to successfully complete a global, fully virtual, and remote EMA inspection., the first of its kind. Ultimately, a robust plan, flexibility, and innovative use of appropriate resources, logistics, and electronic tools were key components of the successful EMA inspection and led to a Conditional Marketing Authorization.