Almac and ESMS, the 24/7 medical emergency response service for clinical trials, have partnered on a service for emergency unblinding procedures.
 
In compliance with E6 Good Clinical Practice (GCP) regulations, the partnership provides clinical trial sponsors immediate access to the clinical assessment for emergency unblinding procedures to support patient safety even if the Principle Investigator is not present. This service aims to reduce time, effort and disturbance to the study subject involved, keeping patient retention at an optimum level and global capture of safety reports.
 
Almac’s 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. Combining this with ESMS’ 24/7 emergency response service provides instantaneous and continuous support should subjects with adverse events require medical support or an emergency unblind scenario occur.
  
“The strategic relationship allows us to combine our knowledge and expertise to enable us to equip clinical trial sponsors with immediate access to information enabling them to make an instantaneous decision whether or not to unblind the patient, even in the absence of the principle investigator,” said Jim Murphy, president of Almac’s Clinical Technologies business unit “This partnership is further evidence of our commitment to help sponsors get their new drugs to market faster by being innovative in all aspects of our service offering.”
 
Rita Fitzpatrick, ESMS general manager said, “We are delighted to team up with Almac to provide this level of support and service to our global clients.”