ESMS provides a 24-hour medical monitoring and emergency unblinding service for clinical trials, 7 days a week. With a global reach supporting over 300 studies covering more than 200k subjects in 80 countries and with over 45 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.
- 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
Key Benefits of working with us:
- Office is staffed 24/7 with access to study information
- Highly trained and qualified scientific team of information scientists
- Calls handled in English or native language
- Highly experienced team of practicing, Senior Consultant Physicians from the UK’s largest teaching hospital
- Immediate medical response within 15 minutes
- All enquires are audio recorded, documented and quality checked
- Reporting within 24 hours
- GCP compliant
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 staffed 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 the ESMS Senior Consultant Physicians, should clinical advice be required.
Our Senior 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.
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/Biotech’s as it is a cost saving route.
ESMS have a flexible working model; we can integrate into your current solution or provide
- Bespoke services
- Single study use
- Full pipeline cover
- Integration with your IRT
- Create dedicated in-country phone lines
- Multilingual service (over 40 Languages)
ESMS aspires to the highest standards of excellence and professionalism. We focus on meeting our clients’
requirements and maintaining a high quality service, including:
Providing a timely and appropriate response to emergency enquiries; using professional expertise and judgement
Fully documenting every enquiry
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.
ISO 9001 Quality Management certified by BSI, FS 594941
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.
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.