In a unique partnership arrangement, Almac, a global leader in advanced clinical technology and support services for the pharmaceutical and biotech industries, and ESMS, the 24/7 medical emergency response service for clinical trials have combined their expert knowledge and decades of experience to offer clients an exclusive solution surrounding emergency unblinding procedures.
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 unique service results in reduced time, effort and disturbance to the study subject involved thereby guaranteeing patient retention at an optimum level and global capture of safety reports.
Almac’s fully customisable Interactive Response Technology service (IXRS®) enables clients to manage key aspects of their clinical trials, including randomization, dosing, drug/clinical supplies inventory management and electronic Patient Reported Outcomes (ePRO) via phone or web. Coupling this innovative solution to ESMS’ 24/7 emergency response service provides instantaneous and continuous support, which exceed regulatory requirements, thereby offering sponsors complete confidence should subjects with adverse events require medical support or an emergency unblind scenario occur.