Hereditary angioedema

  • Development of the evidence base regarding treatment patterns, cost and burden of disease for patients with hereditary angioedema to support the use of a new treatment
  • Communications package in hereditary angioedema
  • Clinical endpoint review, recommendations and update of an FDA submission package in hereditary angioedema
  • Hereditary angioedema clinical trial endpoint review, recommendations and FDA PRO submission package
  • Pooled clinical trial validation analysis of a PRO primary endpoint in hereditary angioedema to include in FDA submission package
  • FDA meeting support for a hereditary angioedema submission
  • Evaluation of market research reports in hereditary angioedema to support PRO submission package
  • Analysis of Visual Analogue Scale (VAS) summary scores with Last Observation Carried Forward (LOCF) in hereditary angioedema
  • Psychometric validation analysis of VAS summary scores in hereditary angioedema
  • Patient interviews for the face and content validation of the Patient Global Impression in hereditary angioedema
  • Psychometric validation of the 6-item and 8-item composite severity scores in hereditary angioedema
  • Consulting on the linguistic validation of a hereditary angioedema questionnaire into French, German and Portuguese
  • Cognitive debriefing of a questionnaire in hereditary angioedema patients
  • Validation and modifications to a questionnaire in hereditary angioedema patients
  • Consultancy services for linguistic validation of a hereditary angioedema diary
  • Publication strategy to present the results of studies in hereditary angioedema
  • Patient interviews to support a PRO submission package in hereditary angioedema
  • PRO briefing document in hereditary angioedema
  • Strategic consulting and analysis in hereditary angioedema
  • Re-analysis of patient composite score in hereditary angioedema
  • Training materials for a PRO questionnaire in hereditary angioedema
  • Publication strategy on hereditary angioedema