Written Documents

APMW is the best available specialist for writing all your scientific and medical documents.

Clinical and Regulatory Documents

• Preclinical Study Reports
• Clinical Study Reports (phases I to IV), compliant with ICH E3 standards
• Clinical Protocols
• Investigator's Brochure
• Investigational Medicinal Product Dossier (IMPD)
• Informed Consent Forms (French, English, Spanish, Italian - Other languages available upon request)
• PSURs
• Narratives
• Submission modules (CTD Sections 2.4, 2.5, 2.6 and 2.7, 4 and 5)
• PILs and Readability questionnaires
• EEC dossiers
• Expert Reports
• Monographs
• Scientific and Protocol Advice

Scientific and Medical Communication

• Manuscripts for international, peer-reviewed scientific and medical journals (over 400 manuscripts accepted by Lancet, Nature, NEJM, JAMA, JPET, etc)
• Oral presentations
• Slide shows
• Posters
• Abstracts
• Proceedings of scientific and or medical meetings

Others

• Training modules (« e-learning ») and presentations
• Quality control and review of submission dossiers, validations and corrections
• English-French, French-English, Spanish-French, and Italian-French translations

Our scientific and medical writers have a passion for their job. They are flexible, reactive and adaptable. As an example, we can often send you the next draft of a document following your comments received by phone within 48 hours.

Whether your document is for the FDA/EMEA, Lancet, JAMA, an independent ethics committee, or a clinical trial, APMW has the scientific and medical experience, expertise, and skills necessary to target your selected audience whilst fully respecting all timelines, guidelines, and requirements.