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 successfully 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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