Clinical Trials Frequently Asked Questions2026-08-06T06:04:25+01:00

Clinical Trials Services:
Frequently Asked Questions

How quickly does ESMS Global respond to incoming calls or emergencies?2026-07-17T02:50:13+01:00

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.

Which qualifications do ESMS Global’s helpline staff hold?2026-07-17T02:50:37+01:00

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.

Are emergency unblinding and serious breach reporting required under clinical trial regulations?2026-07-17T02:51:09+01:00

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.

Does ESMS Global comply with ICH E6 Good Clinical Practice (GCP) guidelines?2026-07-17T02:51:29+01:00

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.

Can ESMS Global integrate with our existing clinical trial systems?2026-07-17T02:52:18+01:00

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.

Which quality management standard is ESMS Global accredited to?2026-07-17T02:54:20+01:00

ESMS Global is accredited to ISO 9001 – the internationally recognised standard for quality management systems – ensuring consistent, high-quality service delivery across all operations.

Is ESMS Global aligned with the 2026 changes to clinical trial regulations?2026-07-17T02:54:59+01:00

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.

How does ESMS Global handle Serious Adverse Events (SAEs)?2026-07-17T02:55:23+01:00

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.

How does ESMS Global support patient recruitment and pre-screening?2026-07-17T02:56:52+01:00

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.

Is ESMS Global subject to audits?2026-07-17T02:57:50+01:00

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.

Who are ESMS Global’s typical clients?2026-07-17T02:59:22+01:00

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.

How does ESMS Global ensure business continuity during an emergency or outage?2026-07-17T03:00:06+01:00

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.

Does ESMS Global support clinical trials regulated by the FDA, EMA, and MHRA?2026-07-17T03:01:25+01:00

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.

How are incoming calls recorded and made available to clients?2026-07-17T03:01:56+01:00

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.

How does ESMS Global protect the privacy of trial site contacts on public registries?2026-07-17T03:05:28+01:00

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.

How does ESMS Global handle enquiries from non-English-speaking participants?2026-08-06T05:33:00+01:00

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.

Does ESMS Global provide technical support for patient companion apps?2026-07-17T05:27:47+01:00

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.

Want to know more?

Complete our enquiry form today, or email us at info@esmsglobal.com to find out how we can support you.





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