Study Specific Deliverables

I have prepared 120+ deliverables for 30+ pharmaceutical and biotechnology companies in 12+ countries (Europe, USA and Hong Kong) including:

• Feasibility reports
• Clinical Study Protocols (CSPs)/CSP amendments
• Clinical Study Reports (CSRs)/abbreviated CSRs
• Patient narratives
• Bespoke reports
• Investigator’s Brochures (IBs) and IB updates
• Integrated Summaries of Efficacy
• Integrated Summaries of Safety
• Clinical summary sections of regulatory submission documents
• Literature reports
• Manuscripts
• Newsletters
• Value Core Dossiers to support product pricing
• Quality Control of all deliverables.

Company Confidential Documents

I have prepared a range of internal (company confidential) documents including:

• Standard Operating Procedures
• Departmental Working Procedures
• Electronic marketing brochures.