Introduction of Electronic Data Capture Systems (EDC) in Animal Health VICH GCP Clinical Studies – Impact of Change for the Animal Health Sector

Jan 11, 2015

Elecotrnic data capture (EDC) has been in the human clinical study arena for a number of years; however, this technology has only recently been introduced to animal health clinical VICH GCP studies. In their paper, Janice Sarasola of Ondax Scientific, Jo McKelvie of EVITA Services and Iain McPhee of Novartis Animal Health discuss the fact that using EDC in animal health VICH GCP studies presents unique challenges based on the logistics of running small and large animal field studies, despite the numerous guidance documents and information available related to EDC for human GCP studies. ...

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Protecting the Supply Chain

Aug 29, 2014 0

In the world of human health, the increased call for establishing a clear and traceable pedigree for pharmaceutical supply chain had driven the US government to take up legislation. Hotly debated by the California Board of Pharmacy and several times delayed, the issue of serialising medications has now been put into law by the federal government, making the issue unavoidable. As serialisation is one part packaging process, one part IT data management, Justin Schroeder of Packaging Coordinators Inc (PCI) explains what the handling of codes means to the process of successful serialisation and establishing a foundation for securing the supply chain. ...

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