ICH E6(R3) in the USA: Current Landscape
On 08th September 2025, the U.S. Food and Drug Administration (FDA) published its final guidance for industry on ICH E6(R3)...
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Things you need to understand about Reference Safety Information
The Reference Safety Information (RSI) is used for the assessment of the expectedness of all ‘suspected’ Serious Adverse Reactions (SARs)...
Trial Master File: E-Mail Communications in Clinical Studies
Communications associated with key decision making and trial conduct is commonly an area raised as deficient during GCP audits or...
Lack of Assessment of Automated Test Execution Tools
Automated test execution tools can be used to improve efficiency and effectiveness. Like other software, test automation software may be...
Validation and Qualification of eClinical Systems (2) – Contracts/Agreements
After the selection of a vendor, appropriate contracts should be put in place prior to the commencement of work. Contracts...
Clinical Quality Risk Management