24/7 Emergency Medical Response
Supporting your clinical trial with a 24hr emergency unblinding service, 7 days a week
With a global reach supporting over 300 studies covering more than 110 thousand patients in 80 countries and with over 45 languages our background and culture are built on providing support in emergency situations.
Our unparalleled experience in providing 24/7 emergency response services allows us to provide strategic solutions to small, medium and global pharma companies.
Many in-house solutions can be fragmented and may be susceptible to failure which can result in major findings or serious breaches during a regulatory inspection. We 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.
Core Services
24/7 Medical Support and Clinical advice.
24/7 Adverse event (AE) management and reporting.
24/7 Emergency unblinding management and reporting.
Global centralised AE intake reporting.
Core Services
24/7 Medical Support and Clinical advice.
24/7 Adverse event (AE) management and reporting.
24/7 Emergency unblinding management and reporting.
Global centralised AE intake reporting.
Language Support across 45 languages
Our model is based on the use of interpretation companies, carefully selected, to deliver high-quality, cost-efficient language support. The service provides real-time language support in over 45 languages which is tested frequently during routine audits and inspections.
Since our callers are highly qualified healthcare professionals, our pragmatic approach in the provision of language support has been complimented by regulatory agencies.
Ensuring regulatory compliance
Our unique association with one of the world’s leading teaching hospitals, Guy’s and St Thomas’ NHS Foundation Trust, means that we have leading practising Senior Physicians who join our calls, within a maximum wait time of 15 minutes to provide any emergency medical advice 24 hours a day satisfying the requirements of ICH-GCP E6-R2 to provide:
“Medical personnel should be readily available to advise on trial-related problems or medical questions”.
“Where investigators need urgent medical advice related to subject participation, they are able to access a medically qualified doctor 24 hours a day.