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

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

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

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 ...

(Photo: CNA/Lim Li Ting) New: You can now listen to articles. SINGAPORE: Guidelines on screen use will be introduced in schools, including preschools, as part of a new national strategy launched ...

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 ...

近期，国际会议协调组织（ICH）发布了新版《良好临床实践指南》（GCP）草案，标志着对临床研究领域监管要求的重要更新。这些变化不仅直接影响制药公司和研究机构的合规性，还将对整个临床研究行业的运作模式产生深远影响。本文将深入剖析新版ICH-GCP的 ...

FDA’s guidance on Integrating Randomized ... Supporting these guidances is FDA’s adoption of Annex 2 to ICH E6(R3) on Good Clinical Practice, “address[ing] the GCP considerations that ...

Besides policies over participation in domestic matches being made mandatory and discouraging travelling separately with the families, the document also provides guidelines on excess baggage limit, ...