Therapeutic Areas

I have prepared documents for study drugs and devices spanning many therapeutic areas, including:

Gastrointestinal System

• constipation, faecal impaction, bowel cleansing for endoscopy

Cardiovascular System

• coronary artery disease, atherosclerosis, myocardial infarction

Respiratory/Pulmonary System

• asthma, cough, cystic fibrosis, lung injury, chronic obstructive pulmonary disease, seasonal allergic rhinitis

Central Nervous System (CNS)

• schizophrenia, bipolar disorder, Parkinson's disease, Alzheimer’s disease, anxiety, depression, pain, headache, attention deficit hyperactivity disorder (ADHD), epilepsy, nausea, cervical dystonia

Infections

• HIV, influenza, hepatitis C, fungal infections, topical infections, helminth and protozoan infections, e.g. malaria

Endocrine System

• diabetes mellitus, acromegaly, growth hormone deficiency

Obstetrics, Gynaecology and Urinary-Tract Disorders

• female infertility, erectile dysfunction

Malignant Disease and Immunosuppression

• breast cancer, colorectal cancer, organ transplantation, follicular non-Hodgkin’s lymphoma, chronic myeloid leukaemia, melanoma

Nutrition and Blood

• hyperphosphataemia, obesity, essential thrombocythaemia, renal failure, stroke

Musculoskeletal and Joint Diseases

• osteoporosis, autologous chondrocyte implantation, rheumatoid arthritis, multiple sclerosis

Ear, Nose and Oropharynx

• nasal decongestants, throat sprays

Skin

• eczema, melanoma, fungal and bacterial infections

Immunological Products and Vaccines

• oncology vaccines, imaging, other devices and diagnostic agents

Paediatrics

I have written protocols, informed consent documents and clinical study reports specifically for trials in children and in accordance with the European Union Directive. I have also written the following article, published in CRfocus :

La Grue N. Clinical trials in paediatrics: The evolving picture in Europe. CRfocus 2005; 16(1): 13-8.

Phase I Clinical Trials

I have extensive experience in preparing documents for Phase I clinical pharmacology and pharmacokinetic studies.