MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a regulatory body...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complian...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publish...
A simple Glance of Log Rank Test in Survival Analysis for Clinical Trial Data Analysis
In clinical trials, especially in cancer clinical trials, at leas...
Clinical Trial Phases and Types of Studies
Phases of Clinical TrialsTable 1: The phases, types, and nature o...
The Importance of Statistical Monitoring in ICH E6 (R2) Addendum
Statistical monitoring (SM) involves the review of ongoing prospe...