24/7 response service for Clinical Trials and Medical Information

Clinical Trials

ESMS provide global coverage for ca 300 studies covering more than 200k subjects in 80 counties and over 40 languages. We recognise patient safety is paramount. Our unparalleled experience in providing 24/7 emergency response services allows us to provide strategic solutions to small/mid-sized and global pharma companies.

ESMS specialise in a robust and reliable continuous service. Many in-house solutions can be fragmented and susceptible to failure which can result in major findings or serious breaches during a regulatory inspection. ESMS receive many enquiries following such a regulatory inspection, suggesting that even the most comprehensive provision by a CRO or internal mechanism still may not be robust enough to stand up to scrutiny from the regulators.

ESMS have worked tirelessly to establish a mechanism that is continuously available and works to exceed regulatory requirements.

Services include:

  • 24/7 Medical Support and Clinical advice
  • 24/7 Adverse event management and reporting
  • 24/7 Emergency unblinding management and reporting
  • Global centralised PV reporting
  • Language and telecoms services
Contact us by email
or call +44 (0)20 7113 7878

Why is ESMS different?

An emergency request for information must be responded to immediately, no matter the time of day no matter its geographical origin. By utilising highly trained and qualified in-house staff, we are able to focus immediately on the needs of the caller and not work through the time consuming process of contacting on call medics or locating Principal Investigator.

Our call centre is manned around the clock by Information Scientists who have a minimum qualification of a life science degree to include toxicology or pharmacology. These Information Scientists are always available and are the direct line of communication from the number on the patient card. With this level of expertise available as a first response, ESMS can quickly ascertain the nature and severity of every call and act accordingly whilst keeping the patient's safety a priority.

Our Information Scientists are trained in specific study details and have direct access to one of the ESMS Consultant Physicians should clinical advice be required. Our Consultant Physicians practice general and internal medicine and specialise in clinical pharmacology and toxicology, ensuring clinical advice is available night and day.

Adverse events or emergency requests for information will present at any time of the day or night. For example, "a patient is admitted to a hospital following emergency in the early hours suffering trauma following an accident". The treating physician requires rapid access to that patient's drug information to effectively treat the patient. Our team is available to access trial information in real time to answer the physician's queries. This avoids an unnecessary code break which could impact on the study and the patient. Our team understand the treating physician needs fast and accurate information. If the treatment has no interaction with the IMP, clinical advice is given to carry out treatment meaning important patient data is not lost and the patient continues to receive what could be a life changing treatment.

Telecommunication

A pivotal part of ESMS is the available telecommunication options. ESMS realise that not all customers are going to need the same solution so there are a number of ways in which we work. Many of our key clients opt for dedicated lines that are secured only for their use.

This enables a client to run their entire portfolio of studies across the globe through the same lines in each respective country where the trials are live. This shared line saves cost and helps to make the service more efficient.

Clients running local or smaller studies can opt to use the ESMS centralised line or have ESMS integrate into their current telecoms solution. This tends to suit the smaller to midsized Pharma/Biotechs as it is a cost saving route.

The Benefits

ESMS have a flexible working model; we can integrate into your current solution or provide bespoke services.

For more information on how ESMS could benefit your study,
contact us by email or call +44 (0)20 7113 7878

Alternatively fill out the Quote Request Form here

Quality Assurance

ESMS aspires to the highest standards of excellence and professionalism. We focus on meeting our clients' requirements and maintaining a high quality service, including:

Emergency Response

Providing a timely and appropriate response to emergency enquiries; using professional expertise and judgement

Documenting

Fully documenting every enquiry

Notifying Clients

Notifying clients promptly of enquiries relating to their products

Safeguarding confidentiality of patients' information is a priority and we have a strong embedded culture of information governance and experience in handling confidential information.

Our clinical trial services comply with ICH Good Clinical Practice and UK and EU legislation relating to the conduct of clinical trials. Our medical information services follow PIPA guidelines and comply with the ABPI Code of Practice as it relates to medical information services.

We have been inspected by the MHRA in routine GCP inspections. Our quality management system is certified to ISO 9001. We achieved accreditation in 2013 and have maintained this with successful annual assessments by BSI. We regularly experience successful vendor audits by leading pharmaceutical companies with extremely positive feedback.

Our staff are committed to achieving consistently high quality services that respond to the needs of our customers and service users. We apply extensive quality control to all our processes in order to identify opportunities for improving the delivery of our services and across the team.

bsi. ISO 9001 ISO 9001 Quality Management certified by BSI, FS 594941

The quality management system is "comprehensive" "well managed and effectively implemented" "Performance measurement is extensive"

– BSI

Global Support

Global Support 24/7

The ESMS service is continuously available and includes out of hours and public holidays all year round. ESMS operates a fully staffed rota that creates a fully functional 24/7 seamless cover made of Information Scientists and Consultant Physicians.

Interpretation Services

Interpretation Services

ESMS operate a truly global service; our real time interpretations are available in over 40 languages and are an important part in providing rapid information in local languages at any time of day all year round. The caller is greeted by a brief message (dependent on telecoms options taken) and during this process the Information Scientist is queuing an interpreter on the call ready to respond to the caller. To ensure high quality levels of service, the caller is placed in a conference environment that allows for caller, Information Scientist and interpreter to be in a real time situation. Where required, the Information Scientist can then additionally conference in an ESMS Consultant Physician to give clinical advice should the situation call for it.