Signant SmartSignals Unified Platform Supports Rapid Implementation Of Rescue Study

Signant Biotech played a crucial role in rectifying the course of an ongoing Phase 3 study for an emerging biopharmaceutical company, stepping in after performance and service concerns arose with the existing vendor. The Phase 3 study, situated in the therapeutic area of CNS, encompassed an adult participant population of over 350 individuals distributed across 55+ sites in the United States. Signant Biotech addressed the challenges faced by the sponsor, which included the need for a rapid implementation plan for study build and migration to ensure a smooth transition between vendors. This was essential to minimize disruption for site users and reduce risks to the study.

Additionally, the sponsor emphasized the importance of fast and seamless post-go-live protocol amendment implementation. Given previous unsatisfactory experiences with the current vendor, the sponsor sought a provider capable of implementing changes swiftly with minimal disruption to sites and patients.

Furthermore, with a second global Phase 3 study in the planning stages, the sponsor looked for a provider that could efficiently implement the integrated EDC and RTSM solution for this upcoming trial. The goal was to ensure a timely implementation and leverage good re-use efficiency from the lessons learned during the implementation of the first study.

See how Signant Biotech's involvement successfully addressed these challenges, contributing to the effective progress of the Phase 3 study and setting the stage for the subsequent pivotal trial.