Clinical Development

• Design of clinical development programs for clinical studies
• Coordination of clinical development programs
• Management of outsourcing of clinical research actvities
• Writing of clinical study reports, study reports and expert reports
• Data monitoring board organization

Regulatory Affairs

• Development of clinical regulatory strategy
• Preparation of Clinical Trial Applications and Investigational New Drug Applications
• Preparation of documents for regulators such as scientific advice briefing documents, IMPD's and eCTD's
• Preparation of and participation in regulatory meetings such as scientific advice meetings, pre-IND and IND meetings, presubmission meetings
  

Management & Organization

• Building, coaching and professionalizing organizations
• Liaison management
• Crisis management
• Change management
• Outsourcing and management of outsourced activties

Project Management

• Design of drug development and project plans
• Setting up project organizations and project teams
• Management of drug development project teams
• Management of clinical development teams

Marketing & Strategic Consultancy

• Product portfolio analysis and product evaluations
• Due diligence for investors
• Marketing input during e.eg. the drug development stage