Afforce Healthcare

Adding value to (bio)pharmaceutical business

Services

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