Petri Dishes

Emergency Unblinding/ Code Breaking

We provide a 24-hour emergency medical response service for the pharmaceutical, biotechnology and contract research industries.

We operate on-site 24 hours a day, 365 days a year. Information scientists have immediate access to all study documentation, including randomisation information in one secure location. An eSMS consultant physician is available within minutes at all times.

 

Emergency Unblinding

The decision to unblind a subject is strictly controlled by client approved procedures to ensure that emergency unblinding occurs only when clinically necessary.

Information scientists are trained and experienced in assessing information about medical emergencies and whether unblinding is necessary for patient safety. Our consultant physicians can be contacted whenever necessary. 

 

Adverse Event Management

Our consultant physicians are able to provide clinical information and advice on the treatment and management of the patient.
Adverse event reports are audio-recorded, fully documented and reported to the client immediately following the enquiry.
 

Client Comment

"We chose to outsource because our people on call simply couldn’t carry codebreaking codes for all trials around."
 

Client Comment

‘The function is difficult to support in-house and we were struggling to manage with resourcing issues."

Our Services

eSMS provide 24 hour:

Emergency Unblinding for Clinical Trials

Medical Response for Clinical Trials

Medical Information for Licensed Products and IMPs

 

eSMS is regularly inspected with positive outcomes, by our clients and the MHRA.

 
Contact Us

If you think you could benefit from our strategic cover please call or email us.

 

Rita Fitzpatrick
eSMS Head of Services

Telephone: 020 7188 0600