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Medical Writing
From conveying complex information to investigators to finding the most effective way of presenting
data to regulatory agencies, Medical Writing is a core skill within any regulatory drug development
programme.
It’s nearly always time-critical too, so we concentrate on ensuring flexibility, accuracy and quality.
Cornaxis offers fully QC’d Medical Writing deliverables:
- Investigator Brochures
- Protocol Synopses, Draft and Final Protocols and Amendments
- Subject Information and Informed Consent Forms
- Subject Narratives
- Clinical Study Reports (phases I to IV)
- Clinical Expert Reports
- Integrated Summaries of Safety and Efficacy
- Abstracts and Manuscripts
Reviews
We also undertake reviews of draft protocols, analysis plans and other documents to ensure they
are fit for purpose and meet international regulatory standards. Expert statistical and medical
reviews can be provided through partner organisations and industry experts.
With considerable experience of working closely with Biostatistics, Clinical Operations, Data
Management, Pharmacovigilance and Regulatory Affairs, Cornaxis can adapt to in-house styles,
templates and standard operating procedures.
Broad therapeutic experience
While we can turn our skills to many therapy areas, you may be interested in our particular
expertise in the following:
- Asthma
- Cystic fibrosis
- Depression
- Dermatology - acne, eczema, psoriaisis, rosacea
- Diabetes
- H. pylori-associated gastropathies
- Men’s Health - erectile dysfunction, genital warts
- Migraine
- Nephrology
- Oncology - breast cancer, prostate cancer, non-small cell lung cancer
- Osteoarthritis
- Schizophrenia
- Urology - benign prostatic hyperplasia, incontinence
- Women’s Health - HRT, vaginal bacteriosis
©2008 Cornaxis Ltd
Patient Recruitment
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