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|November 20, 2017
Quanticate Launches Monitoring Services Following the ICH GCP E6(R2) Addendum
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Quanticate has launched its statistical monitoring service as an extension of its consultancy offering in response to recent amendments to the ICH GCP E6(R2) guidelines which focus on incorporating RBM into trial design. Quanticate will use the RBM approach a long with the evaluation of these designs to conduct tests in order to guide decisions surrounding investigations into data discrepancies and identifying where site directed monitoring visits may be necessary.
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