Filing Cabinet

Case Studies

The eSMS team work hard to ensure that we deliver the best possible service to our clients and their customers.

Case Study: Extraordinary Event

One Saturday evening, we were contacted by police investigating a car break-in. It belonged to a subject on a clinical trial whose trial medications had been left in the car and were now missing. Police were concerned that the stolen trial drugs would appear on the night club scene that weekend. They wanted to know what drugs were involved and the risks associated with ingestion. We contacted the client immediately to inform them of the enquiry and obtain their permission to give the police the requested information. The treatment was unblinded and one of our consultant physicians prepared a press statement with the police.

Case Study: Emergency Unblinding

A subject taking part in a double blind placebo controlled trial presented to A&E with acute onset dizziness, chest pain and collapse. The treating doctor contacted us and requested a codebreak. After ensuring the criteria for an emergency codebreak were satisfied, this was carried out and the A&E doctor was informed of the treatment allocation. Within two hours of receipt of the enquiry a report of the enquiry was faxed to the Sponsor. This report notified the Sponsor that the code had been broken but kept the Sponsor blinded.

Client Study: eSMS Resilience

On 2nd February 2009 the southeast experience the heaviest snowfall in 18 years. Two of our clients suffered severe staff shortages and required urgent cover for Medical Information. Since we are part of a major acute London Hospital Trust, we were operating under the NHS Disaster Plan and were able to provide immediate cover.

Case Study: Medical Information for IMP

A subject on a double-blind, placebo controlled trial was due to attend his dentist for a tooth extraction. The dentist contacted us to find out if the patient was on the study drug, and if there could be an interaction with the local anaesthetic.

After careful review of the study documentation we were able to reassure the dentist that an interaction between the study drug and the local anaesthetic was unlikely.

Emergency unblinding was not necessary.

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