Almac and ESMS Global collaborate to offer clinical trial support
Partnership will link Almac Interactive Response Technology Service with EMS 24/7 emergency response service
Almac and ESMS, the 24/7 medical emergency response service for clinical trials have combined their expert knowledge and experience to offer clients an exclusive solution surrounding emergency unblinding procedures.
In compliance with E6 Good Clinical Practice (GCP) regulations [section 5.13], this partnership provides clinical trial sponsors with 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 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 randomisation, 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 exceeds regulatory requirements, thereby offering sponsors complete confidence should subjects with adverse events require medical support or an emergency unblind scenario occur.
As a result of the combined clinical knowledge base and expertise offered, typically from 95% of calls where emergency unblinding is initially 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.
'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.'
