Global Compliance

Global Compliance

Updates to the ICH GCP (Good Clinical Practice) Guidelines: Quick Review

First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...

Consulting

Understanding GCP Basics

Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officials...

Clinical Research: Phase 1 - Phase 4

Working with a CRO

The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...