How robust are your Emergency Unblinding & Medical Monitoring Arrangements?
ESMS are offering a complimentary ‘test service’ of your existing Emergency arrangements. The findings from this report can be used during your audit or inspections to document external testing of the process and provide evidence of compliance.
ICH-GCP states that “medical personnel should be readily available to advise on trial-related problems or medical questions” and “In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency.”
A medical emergency request must be responded to immediately, no matter the time of day or its geographical origin in order to ensure patient safety. Many solutions can be fragmented and susceptible to failure which can result in major findings or serious breaches during a regulatory inspection.
Over the years, sponsors have come to ESMS following a failed test call during regulatory inspection, suggesting that even the most comprehensive provision by a CRO or in-house medical rotas may not be robust enough to stand up to scrutiny from the regulators.
For further information and to commence your complimentary ‘test service’ please Contact us