Study Management

Each study has a dedicated Study Manager who is responsible for the Study Management Team.  The team is committed to ensuring complete customer satisfaction.  The Study Manager will act as a single point of contact for the customer, whilst the team will: 

  • Provide a Technical Agreement
  • Project manage the research, method development and process transfer functions
  • Provide a Quality Risk Assessment for the project
  • Ensure all necessary qualifications and validations are completed
  • Oversee all aspects of the manufacturing process
  • Resolve issues that arise during the project
  • Handle customer enquiries and provide progress reports
  • Be responsible for product security, storage and ‘chain of custody’
  • Provide support for IND submission