HighPoint Blog

Are your practices for handling TMFs compliant with the new GCP requirements from ICH E6 (R2) coming into effect June 14?

Background for ICH E6 (R2)

The ICH GCP E6 regulation was introduced in 1996 when clinical trials were largely run on paper. Since then, the following trends have significantly increased:

• the scale, complexity, and cost of clinical trials • the degree of outsourcing for... Read More

Are you or your colleagues facing never-ending issues when being audited or inspected? It might be time to start putting your (clinical) house in order.

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Preparation is key to pass your Good Clinical Practice (GCP) inspection. You need to prepare well in advance and certainly not shortly before.

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