Endometriosis

  • Validation of ePRO endpoints and a regulatory dossier to support claims in endometriosis
  • Qualitative research in Europe and validation of ePRO endpoints to support product labelling claims in endometriosis
  • Development and validation of ePRO endpoints for use in endometriosis
  • Psychometric validation and communications for newly developed PROs in endometriosis
  • PRO instrument development in endometriosis
  • Manuscript on PRO development and validation in endometriosis
  • Endpoint validation and finalisation in endometriosis
  • Review of a revision of a psychometric validation report on endometriosis and in-person attendance at FDA meeting
  • Endometriosis symptom diary and impact scale communications strategy
  • Exploration of instrument scoring (following EMA CHMP advice), psychometric evaluation using data from clinical studies and development of instrument user manuals in endometriosis
  • Consultancy services for linguistic validation of an endometriosis symptom diary and endometriosis impact scale
  • Endpoint review and regulatory support regarding the suitability of the Biberoglu & Behrman Scale (B&B) and Endometriosis Health Profile-30 (EHP-30) for supporting US product labelling claims in endometriosis
  • FDA PRO dossier updates and the development of Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) user manuals
  • Review of a briefing book concerning a compound in development for the treatment of pain and other symptoms arising from endometriosis
  • Face and content validity of a new measure to assess symptoms associated with endometriosis
  • Development and face and content validation of a diary to assess symptoms associated with endometriosis
  • Development of disease-specific modules for endometriosis