Mrs Nicola La Grue

• clinical study reports (ICH E3 standard; Phases I, II, III and IV)
• protocols (for Phases I, II and III, and QTc interval for ICH E14)
• informed consent documents
• investigator brochures
• regulatory submission documents (CTD modules)
• standard operating procedures
• manuscripts and abstracts
• training materials
• case report forms
• many other types of scientific documents so please ask if you don't see what you need in this list!

I have great attention-to-detail and am an expert user of Word. I not only have skills in writing, but I also have a keen understanding of statistics, pharmacokinetics and many therapeutic areas. With this in mind, my clients trust me to work confidently with all types of data, statistical and PK analysis. I can produce clearly written text, presenting key data and messages for the appropriate audience.

Expertise:
I have prepared documents for study drugs and devices spanning most therapeutic areas, including (but not limited to):

• gastrointestinal, e.g. constipation, faecal impaction, bowel cleansing
• cardiovascular, e.g. stroke, coronary heart disease, atherosclerosis
• musculoskeletal, e.g. osteoporosis, autologous chondrocyte implantation, rheumatoid arthritis
• respiratory/pulmonary, e.g. asthma, cystic fibrosis, lung injury
• central nervous system (CNS), e.g. schizophrenia, Parkinson's disease, anxiety, depression, pain, ADHD, epilepsy, bipolar disorder, multiple sclerosis
• infections, e.g. HIV, influenza, hepatitis C, parasitic
• endocrinology, e.g. diabetes mellitus, acromegaly, growth hormone deficiency
• genitourinary and gynaecology, e.g. renal failure, infertility, erectile dysfunction
• oncology, e.g. breast cancer
• blood disorders, e.g. chronic myeloid leukaemia, hyperphosphataemia
• dermatology, e.g. eczema, melanoma
• vaccines, imaging, other devices and diagnostic agents.

I have written protocols, informed consent documents and clinical study reports specifically for trials in paediatrics and in accordance with the latest European Union Directive.

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

Other Information:
You can rely on me to work to high standards, within an agreed budget, and I always stick to deadlines.

I am equally comfortable working on my own or within project teams, and I am happy to work on-site or from my fully equipped office at home.

My fees are very reasonable and I can provide a full estimate on a per project basis or by the hour.

I have received accreditation from EMWA.