Clinical Trials Services:
Frequently Asked Questions
Frequently Asked Questions
ESMS Global upholds rigorous response standards: 98% of calls are answered within 20 seconds, and all emergency out-of-hours calls are answered within 4 minutes.
All Information Scientists hold at least a life sciences degree – such as pharmacology, toxicology, or biomedical sciences – ensuring every team member brings a strong foundation of medical and scientific knowledge to every interaction.
Yes. Both are mandatory under international Good Clinical Practice (GCP) guidelines and regional regulations, including EU Clinical Trial Regulation No. 536/2014 and UK/US FDA guidelines. Serious breach notifications must be submitted within seven calendar days of becoming aware of an incident.
Yes. ESMS Global provides round-the-clock access to Medical Information Scientists and Senior Consultant Physicians within 15 minutes, resolves approximately 95% of inquiries without unblinding, and reports 100% of Serious Adverse Events (SAEs) to the sponsor’s Pharmacovigilance department within 24 hours.
Yes. ESMS Global’s services are IRT (Interactive Response Technology) agnostic and highly adaptable, enabling seamless integration with both standard ESMS systems and client-specific trial management platforms.
ESMS Global is accredited to ISO 9001 – the internationally recognised standard for quality management systems – ensuring consistent, high-quality service delivery across all operations.
Yes. ESMS Global has fully updated its operational procedures and systems to comply with the new UK regulatory framework that came into effect on 28 April 2026, which introduced significant changes to clinical trial governance, risk management, and documentation standards.
100% of SAEs are processed and reported to the sponsor’s Pharmacovigilance department within 24 hours of intake, in full compliance with all applicable regulatory requirements.
ESMS Global triages inbound enrolment enquiries and conducts pre-screening eligibility questionnaires based on the study protocol. This reduces the administrative burden on site staff while helping to identify the most suitable participants efficiently.
Yes. ESMS Global undergoes regular audits to verify ongoing compliance with regulatory standards, quality management requirements, and the service commitments made to clients and trial sponsors.
ESMS Global’s clients include pharmaceutical and biotechnology companies, Contract Research Organisations (CROs), and academic or public research institutions – such as Clinical Trials Units – that require continuous 24/7 safety and medical information support.
ESMS Global operates validated computer systems and maintains a robust, regularly tested disaster recovery plan, ensuring all response lines remain fully operational regardless of external disruptions.
Yes. ESMS Global supports trials regulated by all three major authorities – the FDA, EMA, and MHRA – ensuring full compliance with each body’s specific reporting and safety requirements.
All calls are recorded and stored in line with regulatory standards. Clients receive secure, direct access to call recordings and associated documentation as part of their service package.
ESMS Global lists only its own centralised contact details on public registries such as ClinicalTrials.gov. This protects the privacy of investigators and trial staff, and prevents them from being inundated with non-urgent enquiries.
ESMS Global offers multilingual support across more than 45 languages, using professional interpreters and industry-standard global call-centre telecommunications to assist callers in their preferred language.
Yes. ESMS Global offers technical support for Software as a Medical Device (SaMD) and patient-facing apps. Where issues require specialist expertise, they are escalated promptly to the appropriate development or technical software team.
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Complete our enquiry form today, or email us at info@esmsglobal.com to find out how we can support you.






