FDA & EMA COA qualification programs
This blog presents regulators’ opinions which can facilitate COA selection in drug development.
eCOA implementation: how to ensure equivalency with the COA paper version
Mapi Research Trust presents its rigorous process to ensure the equivalency between the electronic and the paper versions, and the validity of the data electronically collected, based on the eCOA best practices.
Clinical Outcome Assessments' copyright
This blog gives you keys to understand the copyright, how to obtain permission to use a COA, and what rights are granted with a license to use a COA.
How to successfully prepare the licensing of Clinical Outcome Assessments
In this blog post we detail key steps of COA licensing, risks and common pitfalls, as well as mitigation plan to ensure streamlined COA licensing.
Best practices to keep eCOA implementation off the critical path of clinical trial startup.
This blog post details eCOA implementation best practices: key steps and 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.