Current Edition

Simplifying the Process of Managing Complex Country-by-Country Regulations in Clinical Trials

Clinical trials themselves have their own complications. Regulatory compliance and safety reporting are of the utmost importance in managing clinical trials. When you add to this how the regulations change in various countries across Europe – and the world – the complexities are exponentially greater. Karin van Dort at Pharmasol reviews how a central hub can simplify tracking country rules for compliance. This approach can feature dynamic templates, which can be modified to meet local requirements, help to set a standard for tracking each country’s regulations and upon distribution to clinical trial investigators, can be blinded to avoid putting clinical trial information in jeopardy.