Download Presentation: Ensuring clinical trial site quality for FDA, EMA and local inspections

Regardless of the region in which you are operating clinical trials, sites can be scrutinised by the FDA, EMA and local inspectors – and just because you are operating in one geographic region doesn’t mean that you are exempt from inspections by authorities that govern another geographic region. Between 1994 and 2010, the FDA performed 230 inspections in CEE – …

Statistics show increase in clinical trials in emerging markets

Latin America, Central and Eastern Europe (CEE) and parts of Asia are often classified as ‘emerging markets' within the pharmaceutical sector. Recent years have seen huge growth in pharmaceutical operations within these regions – more R&D, more manufacturing, more outsourcing service providers and more partnering/M&A opportunities. As is depicted below, the number of clinical trials initiated in the CEE region …