Biostatistics now a regulatory must28 Oct 2025 07:28
The Company regularly reviews regulations changes through proactive discussions with key industry officials, professional advisers and regulatory bodies where appropriate.
Major agencies such as the FDA are actively promoting the use of Modelling and Simulation (Quantitative Pharmacology) and issue advisory papers which set out their thinking.
Biometrics, which includes Biostatistics, Statistical Programming and Data Management are required under international regulation (ICH E9). This means that all interventional clinical trials setup and run across major markets (including the US, EU, UK, Switzerland, Japan, South Korea, and Australia.)