Best practices to keep eCOA implementation off the critical path of clinical trial startup.
eCOA best practices: this blog post details the key steps of eCOA implementation, solutions to keep eCOA off the critical path of clinical trial startup.
Patient-Reported Outcomes as Endpoints in Oncology Labeling Claims: An FDA/EMA Perspective
This blog post details the differences in approaches between FDA and EMA that are critical for sponsors to develop PRO strategies for drug labeling claims.