Clinical Pharmacology

• Phase 1-4 protocol design and development
• Pharmacokinetic / toxicokinetic data analysis and interpretation
• Clinical study report writing 

• Clinical pharmacology sections of investigator brochures and other regulatory documents, including:
  • Periodic Safety Update Report (PSUR)  
  • End of Phase 2 and pre-NDA meeting request and briefing package
  • MPA scientific advice briefing packages
  • Label updates / revisions
  • EU renewal for marketed product 
  • Clinical Pharmacology sections of CTD 
• Writing of abstracts, posters and manuscripts

Project Management

• Generation of development and risk management plans
• Development of target product profile (TPP)
• Development of:
  • Product review process
  • Team and governance structure handbook
  • Clinical study best practices
• Generation of product communication plan, or annual corporate communication calendar