Global Clinical Trials Activity in the Details
Individual countries hold the key to finding hot spots in growth regions like Central and Eastern Europe.
Monitoring the Monitors
Guidelines and a checklist ensure those responsible for subject safety and data validity are doing their jobs.
Compassionate Use Guideline Finalized
Industry and patient groups embrace new rules but acknowledge concern over initiative's impact across EU.
Legislation Expands FDA Oversight, IT Systems
Additional testing and monitoring requirements promise many changes for pharma R&D.
Eyes Wide Open
Until adaptive trials are the norm, industry needs to proceed with care and an iterative approach.
Press One for Safety
IVR systems can capitalize on exposure data and analyze adverse events much earlier.
A Time for Compassion
What Canada, the EU, and United States are doing to update their compassionate use regulations.