SmartSignals eCOA Facilitates Mid-Study Amendments in an Oncology Trial

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Case Study

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, introducing several new challenges as a result of this mid-study change including:

  • Signant’s eCOA team had to add 350 patients, 50 sites, 5 countries, and 10 languages to the study
  • Two additional PROMs had to be acquired, translated, and implemented on provisioned smartphones and tablets
  • 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.

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