An emerging biopharmaceutical company needed assistance in expediting the initiation of a Phase 1 oncology trial for a novel treatment targeting relapsed/refractory multiple myeloma, which aimed to contribute to the successful application of breakthrough therapy designation. The Phase 1 study, conducted in the field, involved a participant population of adults distributed across 10+ sites in the United States. The trial engaged 65+ participants and aimed to address challenges associated with accelerating Phase I to facilitate an early breakthrough therapy application.
The sponsor faced frustrations with existing vendors in meeting study timelines and varying degrees of expertise in translating protocol requirements into eCRFs and designing study-specific solutions. In response, Signant Biotech emerged as the chosen vendor capable of delivering on time, streamlining collaboration by applying disease indication expertise to protocol interpretation, EDC solution development, and study database creation.
Another crucial challenge addressed was the need for comprehensive patient oversight and study management. The sponsor sought a vendor with disease indication expertise to provide real-time access to insightful medical and statistical monitoring data, enhancing both patient oversight and overall study management.
Additionally, the sponsor aimed to expedite database lock and ensure timely study analysis, crucial for breakthrough therapy designation with the FDA and PRIME eligibility application with the EMA. Given the study's critical role in regulatory submission, achieving a rapid database lock emerged as a vital element in the overall success of the Phase 1 study.
Uncover how the biopharm was able to overcome these challenges by accessing the case study below.