Medical Writing

Documents Prepared by Beardsworth:

• Clinical Study Reports
• Clinical Standard Operating Procedures
• Investigator Brochures
• Protocols -- Phase I to IV
• Case Record Forms
• Annual IND Reports
• Integrated Safety and Efficacy Summaries
• Risk-Benefit Summaries
• Draft Package Inserts
• New Drug Applications
• Product Licensing Applications
• Four-Month Safety Updates
• Technical Responses to Agency Queries
• FDA Meeting Information Packages
• Advisory Committee Meeting Presentations
• Manuscripts and Monographs