SmartSignals eCOA Facilitates Mid-Study Amendments in an Oncology Trial Date Published: Apr 11, 2022 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 studyTwo additional PROMs had to be acquired, translated, and implemented on provisioned smartphones and tabletsChanges 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. Learn More Share: LinkedInTweet Recommended Resources Digital Health Technologies (DHTs) in Clinical Trials: Key Points from the FDA’S Important Draft Guidance Download Now Whitepaper Oncology Solutions Overview Download Now Brochure Non-Small Cell Lung Cancer Solutions Download Now Brochure