The International Council for Harmonization addendum to the ICH E6 Guideline for Good Clinical Practice (ICH E6 R2) and EU regulation 536/2014 strongly backs the adoption of risk-based monitoring (RBM) of clinical trials.  Despite the regulatory advocacy and the perceived benefits of RBM, industry adoption is still slow due to misconceptions about what type and […]

In 1996, when ICH GCP E6 (R1) was introduced, the clinical trials process was paper-based, and spreadsheets served as the primary manual computation and compilation tool for managing various clinical trial processes. Now almost two and half decades later, with the industrial adoption of revised ICH GCP E6 (R2) guidelines that recommend the usage of […]