Facilitating Mid-Study Amendments in an Oncology Trial

Signant’s SmartSignals eCOA solution played an essential role in gathering reliable, patient-reported outcomes (PRO) data in a global oncology study.

After positive interim results, the sponsor added new patient cohorts, including 350 patients, 50 sites, 5 countries, and 10 languages to the study.

Two additional patient-reported outcome measures (PROMs) also had to be acquired, translated, and implemented on provisioned smartphones and tablets, and changes had to be implemented rapidly to keep to the accelerated study schedule.

Read this case study to learn how Signant’s eCOA, scale management and localization services, as well as our global logistics expertise helped keep the study on schedule despite protocol amendments, ultimately enabling the approval of a novel therapy.