Almac, a global provider of advanced clinical technology and support services, and ESMS, a 24/7 medical emergency response service for clinical trials based in the U.K., are collaborating to offer clients an exclusive solution surrounding emergency unblinding procedures.
In compliance with E6 Good Clinical Practice (GCP) regulations [section 5.13], the partnership provides sponsors immediate access to the clinical assessment for and, if deemed appropriate, emergency unblinding procedures to support patient safety even if the Principle 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 customizable 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 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.
Typically from 95% of calls where emergency unblinding initially is requested, only 5% are actually performed. This reduces the significant expenditure concerned with acquiring new patients to ensure the trial is not compromised.
“The strategic relationship we have formed with ESMS 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.