Clinical Development and Clinical Operations

The team at CNE have extensive experience in setting up and running clinical development programmes in all major territories, across a broad range of therapeutic areas.

Clinical Development

  • Clinical development strategy; seamless approach to clinical development planning, across all Phases, to achieve high quality value inflexion points on time and within budget
  • Shortest time to GO/NOGO development decision points, budget forecasting and optimized cost containment
  • Innovative approaches to study design, to generate robust data and maximize return on investment. Proof of Concept study expertise
  • Independent objective assessment of unexpected study results/study salvage
  • Advisory board participation and management

Clinical Operations

  • Clinical project planning, management and execution
  • KOL selection and study site evaluation
  • CRO/vendor selection and management
  • Protocol/Study report writing and review
  • IRB/EC R and D submissions
  • Medical monitoring