Ms. Helen Kulesza BSc, MPhil
Acorn Medical Writing Limited
Skills And Services Offered:
Writing of Regulatory Documents and Manuscripts: Clinical Overview (Section 2.5), Summary of Clinical Efficacy (Section 2.7.3), Summary of Clinical Safety (Section 2.7.4), Literature Reviews, Paediatric Investigation Plans, Investigator's Brochures, Clinical Study Reports, Clinical Study Protocols, Post Marketing Surveillance Study Reports, Obsevational Studies, Health Economics Reports, SOPs.
Translation: German into English
Therapeutic Areas: cardiovascular, central nervous system (neurology and psychiatry), gastroenterology, haematology, immunology (including vaccines), infectious diseases, lumbar surgery, metabolic diseases, molecular biology, nephrology, oncology, respiratory, rheumatology.
Therapeutic Indications: anaemia, asthma, cardiac insufficiency, chemotherapy induced nausea and vomiting, degenerative disc disease, dementia, depression, diabetes, lymphoma, Parkinson's disease, rheumatoid arthritis, smallpox, tinnitus.
With degrees in Biochemistry and Genetics (BSc Nottingham University, UK) and Molecular Biology (MPhil Edinburgh University, UK) and 9 years' experience of writing regulatory documents, largely for MAA submissions, I offer a high quality and thorough service.