Endpoint reviews and briefing documents

Endpoint reviews with an FDA component

  • Diabetic foot ulcers
  • Diabetic macular oedema
  • Diarrhoea-predominant irritable bowel syndrome
  • Dysmenorrhea
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Functional digestive disorders (post-prandial distress syndrome)
  • Hereditary angioedema
  • Hypogonadism
  • Major depressive disorder
  • Pain
  • Pulmonary arterial hypertension
  • Retinal vein occlusion
  • Rheumatoid arthritis

Regulatory briefing documents and PRO dossiers

  • Allergic rhinitis
  • Chronic obstructive pulmonary disease
  • Chronic pain
  • Constipation predominant irritable bowel syndrome
  • Crohn’s disease
  • End stage renal disease patients on haemodialysis
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Erythematous rosacea
  • Eyelash satisfaction questionnaire
  • Facial wrinkling
  • Functional digestive disorders (post-prandial distress syndrome)
  • Glioblastoma
  • Heart failure
  • Hereditary angioedema
  • Hereditary hemochromatosis
  • Hunter’s syndrome
  • Hypogonadism
  • Major depressive disorder
  • Multiple sclerosis
  • Pre-menstrual dysphoric disorder
  • Psoriasis
  • Retinal vein occlusion
  • Rheumatoid arthritis
  • Spinal cord injury
  • Smoking cessation
  • Ulcerative colitis

Study endpoint reviews

  • Bone healing
  • Chronic pain in malignant cancer
  • Epilepsy
  • Fatigue and functioning in fibromyalgia
  • Female hypoactive sexual desire disorder
  • Fibromyalgia
  • Heart failure with preserved ejection fraction
  • Goitre
  • Inhaled insulin in type 2 diabetes
  • Opioid addiction
  • Rheumatoid arthritis
  • Review of a protocol and protocol amendment for a Phase II gastroparesis study which includes the CGSI as a primary endpoint