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