Clinical Studies

Study Planning Phase

• Preparation of study protocols in collaboration with sponsors and investigators
  
• Preparation of patient information and patient informed consent forms
  
• Design of paper-based Case Report Forms
  
• Programming of electronic Case Report Forms
  
• Feasibility assessments
  
• Investigator recruitment
  

Study Initiation

• Preparation of applications for ethics committees and regulatory authorities
• Organisation, preparation and implementation of investigatorīs meetings
  
• Conduct of training events for clinical trial staff

Study Conduct

• Trial monitoring according to ICH-GCP / FDA and local regulations
• Project management
• Handling of investigator fee payment
• Real-time checking that all parties’ work methods conform to agreed SOPs