Good Clinical Practice (GCP), the bedrock of ethical and ... of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the ICH E6(R3) draft guideline for public consultation ...

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Richard Young, chief strategy officer, CluePoints, ...

Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals. The first step is ...

Market OverviewThe Global Contract Research Organization Market was valued at USD 69.25 Billion in 2022 and is projected to ...

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Richard Young, chief strategy officer, Cluepoints, ...

The US Food and Drug Administration (FDA) released draft guidance in December 2024 ... and pay attention to the difference between GCP non-compliance issues and protocol deviations.

The responsibilities a CRA assumes are defined both in The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and China’s own GCP, but either ...

International Conference on Harmonization (ICH). E6(R1). Good Clinical Practice: Consolidated Guideline. ICH web site [online], (1996). International Conference on Harmonization (ICH). E5(R1).

All-cause mortality. Proportion of participants with one or more serious adverse events. We will use the International Conference on Harmonization of technical requirements for registration of ...

Detect compliance and security violations across Infrastructure as Code to mitigate risk before provisioning cloud native infrastructure. Complete Practical Study Plan to become a successful ...