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Sponsors
FDA Diversity Action Plan in 2026: Is a Diversity Action Plan Still Required for Clinical Trials?
The Diversity Action Plan requirement has been the most talked-about, least enforced piece...
Deeksha Gitta
Patient tokenization in clinical trials: How sponsors link trial data to real-world outcomes
Real-world data has moved from a supporting cast in clinical development to a central char...
Paramraj
Risk-based quality management under ICH E6(R3): what sponsors need to understand
Clinical trial quality used to sit in a section. Under ICH E6(R3), it sits in the spine. T...
Deeksha Gitta
What ICH E6(R3) means for sponsors: quality by design from day one
The International Council for Harmonisation (a global body that aligns drug-regulation sta...
Mahesh Upadrista
Comparison groups built from data: a plain guide to synthetic control arms
Many clinical trials still need a comparison group, but a growing number of them build tha...
Anish Teepireddy
Master protocols and portfolio strategy: choosing between basket, umbrella, and platform designs
The default way to develop a drug used to be one trial per question. One asset, one indica...
Vamshi KantojuPage01of12
