Correcting The Misconceptions Of ICH E6(R2) Compliance

By Chris McSpiritt

I recently met with the clinical operations team at a pharma company to discuss the team’s goals, priorities, and initiatives. Not surprisingly, one of their key mandates was to be fully compliant with ICH E6(R2) to ensure they wouldn’t receive any inspection findings. While the leadership team was concerned they didn’t have the right processes and technologies in place to be compliant, a few of the clinical operations functional leads didn’t foresee any issues.

Successful and compliant oversight in outsourced clinical trails requires sponsors to have access to data and the ability to act on the data and document actions. Read about the common misconceptions of ICH E6(R2) compliance and how you can correct them.