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 24, 2014
Almac and ESMS Global Collaborate on Emergency Unblinding
Almac and ESMS have combined their expert knowledge to offer clients an exclusive solution surrounding emergency unblinding procedures.
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In compliance with E6 Good Clinical Practice (GCP) regulations [section 5.13], this unique partnership provides clinical trial sponsors immediate access to the clinical assessment for and, if deemed appropriate, emergency unblinding procedures to support patient safety even if the Principal Investigator is not physically present with the patient. This service is designed to reduce time, effort and disturbance to the study subject involved to help patient retention and global capture of safety reports. This is achieved through Almac's IRT service with ESMS' emergency response service.
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