Development of a COA dossier to support a new clinician-reported instrument, for submission to the FDA 

The challenge

Our client had developed a new clinician-reported instrument to support the primary endpoint in a phase 3 trial. The instrument had been developed according to FDA methodology but the development process was not written up; all the evidence was contained in electronic source documents. 

Our solution

We worked closely with the team who had developed the new instrument to rapidly review and identify the evidence required for the COA dossier and to synthesize it in the format required to facilitate FDA review. 

The outcome

Our substantial experience ensured a streamlined and efficient process to develop a high-standard COA dossier supporting the use of the new clinician-reported instrument as a tool for collecting data to support the primary outcome in the trial.