COA Dossier development

COS has authored numerous evidence dossiers to defend a COA’s inclusion
in the label and defended them at the FDA and EMA.

Dossier development

Increasingly, the FDA and EMA are requesting an evidence dossier to defend a COAs’ inclusion in the label.  The dossier outlines in detail:

  • how the content of the measure was developed
  • the strength of the measures’ psychometric properties and,
  • importantly, definition of a meaningful change threshold. 

In addition to this validation history there is a need to provide details about how the measure was implemented in the clinical trial(s) e.g.:

  • rigour of translation process
  • adjustment for multiplicity in the endpoint hierarchy
  • training for sites on how to administered the measure.

Who to speak to: Tara Symonds

 Tara Symonds

Tara Symonds can be reached at our European Office:

Unit 68, Basepoint, Shearway Road,
Shearway Business Park, Folkestone, Kent,
CT19 4RH

01303 661026