Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|January 22, 2018
CluePoints Launches Risk-Based Monitoring Starter Pack
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CluePoints has launched the “CluePoints RBM and ICH E6 (R2) Starter Pack” to help small and medium-sized enterprises achieve regulatory compliance through a “risk-based” approach. This starter pack helps to address the problem of embracing RBM through the use of consultation on the ICH E6 addendum and RBM methodology. This will further help organizations understand the regulation and aims to improve costs and resources all while providing them with the necessary tools.
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