One of the great compliments a client can give their CRO is to request advice and counsel on fixing a clinical study that is broken, stalled in its start-up phase, or having trouble engaging sites or enrolling patients.
Rescue studies are often challenging for any CRO, but Medelis has been entrusted with a number of rescue studies by its clients.
Medelis has even been engaged as a rescue CRO, in total confidence, tasked with preparing and staffing a replacement study management team and new study plan, that was ready to take over on an agreed upon date when the previous CRO was terminated.
From our experience handling these rescue studies, the Medelis team has developed a rescue study procedure for its clients which includes:
In virtually every case, the new team has been able to reverse almost all problems, and regain most of the lost time, with minimal additional expense to the client.
A top 5 pharmaceutical company had a severe bottleneck with the internal clinical review of patient profiles, statistical output, endpoint assessments, protocol deviations, and SAE reconciliation. Development timelines for their critical, high-profile agent were being negatively impacted. The client’s clinical operations team was unable to identify and staff appropriate team members with the skills and oncology experience required to successful eliminate the backlog and keep up with the high-volume of patient data.
Medelis was contracted to supplement the client’s team and assist with the review and reconciliation of the key efficacy and safety data. Our highly-experienced, oncology expert team successfully turned a “weak” link in the process into a strength. Recognizing the value of the specialized service that Medelis can provide in this area, Medelis is now providing the client similar services for other studies in the US and Europe.
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