Drug Development
• Review of pre-clinical pharmacological and toxicological
data
• Provision of medical and scientific input into drug development
plans and study design
• Clinical Trials: from first entry to man to marketing authorisation
application
• Steering committee and investigator meetings
• Study design
• Writing and review of protocols, statistical analysis
plans, clinical trial reports, investigator brochures
• Provision of cover as Principal Investigator or Medical
Adviser
• Review of coding of adverse events, diseases and medication
Regulatory Affairs
• Writing of sections of CTD, Clinical Expert Reports, Summaries
of Efficacy and Safety
• Preparation of response to regulatory concerns
• Writing clinical sections of CTA / IND
