ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
Study Protocols
Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
Investigator Brochures
Patient Safety Narratives
Patient information including Informed Consent, Lay Person Summaries and Patient Brochures
Pharmacovigilance documents such as Periodic Safety Update Reports
Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Clinical Research Organization (CRO)
Standalone Quality Checks
Scientific Communications
Conference materials (abstracts, poster presentations and slide sets)
Manuscripts
Editorial support
Journal/conference submission
Product website content (for both scientific and patient audiences)
Educational material for patients, healthcare professionals and pharmaceutical industry personnel
Medical marketing reviews and reports
Literature reviews
Publication planning
If this sounds of interest please send your CV.
