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.
“The publication of our manuscript by such an esteemed journal highlights the continued hard work and dedication of many men and women to develop and provide innovative, desperately needed, and life-saving therapies to patients in spite of the disruption the COVID-19 pandemic has caused in our daily lives,” said Tony Cruz, DVM, Senior Vice President, Quality Assurance. “We hope that this article serves as a road map for drug development companies who share a similar dedication to patients and the development of novel, life-saving therapies.”
For a copy of the article, please go to www.inclin.com/news/.
For information about Quasar, including obtaining a copy of Issue #154 January 2021 edition please go to www.therqa.com.
InClin is a full-service Contract Research Organization (CRO) with offices in the San Francisco Bay Area and Sydney, Australia. We are a single source provider of an integrated full suite of clinical development services from Phase 1 to Phase 4, including project management, clinical monitoring, site and contract management, vendor management, data management, biostatistics, programming, drug safety, medical monitoring, medical writing, QA inspection readiness, and strategic consulting services. For more information visit www.InClin.com or contact us at firstname.lastname@example.org.
Office Phone: (650) 376-4086