Case Study

Celgene Leverages ERT eCOA Data for FDA Approval

Source: ERT
Celgene Leverages ERT eCOA Data for FDA Approval

Celgene Corporation is an integrated global biopharmaceutical company, engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Celgene wanted to determine whether patients treated with OTEZLA®, an oral inhibitor of phosphodieasterase-4 (PDE-4) would show improvement in signs and symptoms of PsA, and used ERT eCOA tablets to collect data about patient symptoms as observed by physicians through the ACR assessment which was used to assess efficacy. In this ebook, learn how Celgene used the eCOA tablets to collect primary and secondary endpoints and ensure completeness and quality of data collected. Results showed reduced monitoring time and costs, decreased time to database lock, and FDA approval