24/7 response service for Clinical Trials and Medical Information
Available 24/7, ESMS provides Medical Information services for licensed products that are tailored to suit the needs of each client. Whether it be as a 24 hour full service, on ad-hoc days as emergency cover or as an out of hours service, ESMS ensure that Medical Information is provided as it would be from a client's own information department. Our centralised information centre is staffed by highly skilled Information Scientists with Life Science degrees which include Toxicology, Pharmacology and Pharmacy. Our consultant physicians practice general and internal Medicine and specialise in Clinical Pharmacology and Toxicology and are available at all times for clinical information.
ESMS provides a comprehensive Medical Information service for licensed products and our services cover all groups of product users:
Nurses and carers
We recognise that Medical Information is often the first point of contact with an enquirer and we are committed to the highest level of customer service and getting it right the first time. The information provided by our Information Scientists is tailored to the need of the client. This could be from resources provided and approved by the client (SPCs, PILs, FAQs) or supplemented by our in-house information resources to answer enquiries about:
Use of the product
Product Quality Complaints
As well as the management of the initial enquiry, ESMS also ensures that safety data is reported within an agreed timeframe (usually 24 hours) to the relevant Pharmacovigilance department by the Information Scientist who dealt with the enquiry initially; this ensures accuracy of the reported data.
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
The quality management system is "comprehensive" "well managed and effectively implemented" "Performance measurement is extensive"
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.