Introduction
Axis Clinicals, one of the largest full-service clinical/biopharmaceutical development provider, wanted to implement ClinSpark phase I automation system, to enhance its regulatory compliance. The system being GxP required a formal validation of implementation and configuration.
Key Challenges:
- It was required to configure ClinSpark as it was a turnkey, enterprise-level system.
- Existing Axis Clinicals workflows and documentation needed to be modified to accommodate ClinSpark’s enhanced capabilities.
- Validation of technology, workflow process, governance and control was required.
What was achieved for the client:
- Reduction in Human errors by 85%
- Reduction in Cost by 40%
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