Menu Back to Poster-Presentations-Details

T-27: Key Aspects and Lessons Learnt for Maintaining a Robust and Efficient Global 24/7 Medical Emergency Coverage Service

Poster Presenter

Vincent Philiponis

Medical Director, Medical Affairs
ICON, plc.
United States

Objectives

Analysis of key elements and process requirements to maintain and continuously optimize a fully robust and efficient global 24/7 medical emergency coverage system within a global Contract Research Organization (CRO).

Method

Continuous review and process optimization of a global 24/7 medical emergency service for fatal or life-threatening events, intoxications with an investigational product, or urgent safety issues. Analysis is based upon results and outcome of real emergency calls, test calls, audits and inspections.

Results

A ‘follow-the-Sun’ principle has been applied to this global 24/7 service. Four 24/7 physicians globally are on-call each week with one physician on-call per region (APAC, Europe, LATAM, North America). A single HelpDesk (HD) call centre acts as central point of contact for the sites. Depending on the time of the day, 24/7 calls will be transferred by the HD Operations Support Analyst (OSA) to a 24/7 physician who is currently during his/her day time. Transfer of the call does not depend on the region of the caller. Key aspects: Administration: • Dedicated 24/7 medical administrative team (MAT) • 24/7 accessible, central document repository • Quarterly test calls by the 24/7 MAT • Periodic calls between 24/7 MAT and HD oversight team. HelpDesk: • Periodic motivational/background calls to the OSAs • Regular email refreshers to all OSAs on key 24/7 aspects • Case scenarios with active feed-back request to the OSAs. Refresher training as needed • Confirmation to the 24/7 MAT on upload of new on-call physicians rota plans or study lists. Language line at the HD: • Ability to immediately conference-in a translator • Menu prompt options for language support. Study integration and document management: • Confirmation from each 24/7 physician that he/she is not assigned as unblinded Medical Monitor (MM) or has otherwise access to unblinded data for that drug • Study lead MMs must send all 24/7 documents to the 24/7 MAT prior to service start. Pro-active document up-dates once available. • Documented provision of 24/7 contact details to sites in monitoring trip reports. Quarterly up-dates checks: • Requesting all study lead MMs to confirm that all 24/7 documents are complete and still valid or if new documents are available for their study/ies • Check for new studies to be integrated. Calls received: • Detailed tracking of all calls including internal and external test calls • CAPA for each call not handled in line with the process flow.

Conclusion

Follow-the-Sun Principle: • During business days, the 24/7 physician can directly check with an assigned study MM if he/she is not involved in that study • Should prevent answering of calls during the night • Each physician on-call must be available 24/7 to act as back-up, if the HD OSA cannot reach the 24/7 physician who should be contacted as per time of the day. Within a global CRO, study MMs are assigned to multiple projects. Pro-active support needs to be provided to the MMs to ensure that the 24/7 MAT has all the latest documents and is informed of any new study integration. Quarterly up-date checks have been implemented asking for active feed-back on current document versions and new studies for integration. For each study, all 24/7 physicians must actively confirm their blinding status to avoid having unblinded MMs working on the 24/7 rotation. Menu prompt options for language support need to be available when using a single HD call centre (English as default language). Conferencing-in of a translator must be possible within minutes. 24/7 medical emergency calls are rare. It is challenging for the HD OSAs and 24/7 physicians to develop a routine. Periodic test calls are mandatory. In addition for the HD, at least monthly refreshers and case scenarios for the OSAs requesting active feed-back significantly helped keeping the process flow fresh and on everyone’s mind. Several back-up layers and constant re-evaluation are required for a robust 24/7 medical emergency service ensuring 24/7 availability of a qualified physician and fully up-to-date 24/7 study documents. Scope of such robust system could be expanded to not only cover for medical emergencies. Other options include e.g. 24/7 availability of trained MMs for eligibility checks in studies with time-critical enrolment or 24/7 support for specific adverse event handling procedures and algorithms in e.g. Oncology studies. Co-author: Michael Marx, MD