Applied Clinical Trials-09-01-2007

Individual countries hold the key to finding hot spots in growth regions like Central and Eastern Europe.

Guidelines and a checklist ensure those responsible for subject safety and data validity are doing their jobs.

Industry and patient groups embrace new rules but acknowledge concern over initiative's impact across EU.

Additional testing and monitoring requirements promise many changes for pharma R&D.

Until adaptive trials are the norm, industry needs to proceed with care and an iterative approach.

IVR systems can capitalize on exposure data and analyze adverse events much earlier.

What Canada, the EU, and United States are doing to update their compassionate use regulations.