Serious Breach
Reporting Service

We help sponsors to be compliant by providing a dedicated helpline and email for the reporting of serious breach incidents

Changes in legislation (as of 2023) mean that all clinical trials approved by the European Medicines Agency are required to have a dedicated helpline and email – it is the Sponsor who must provide the PI with a dedicated, unique email address and telephone number that can be reached at all times regarding serious breaches.

Our solution is in place and ready

ESMS Global already provides a helpline and email to a major global pharmaceutical company to meet this requirement.

Not quite sure? Register your interest and we will be in touch.

    • Support in 45 languages

    • Available 24/7 365

    • Operates worldwide

    Our clients

    Contact us

    Call us on 0044 207 113 7878 or email

    Or complete our enquiry form to find out how we can support your next study.