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.
Axis Clinicals conducted a regulatory risk assessment and determined that ClinSpark system was required to be implemented. For this implementation, there were some challenges ahead.
- 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.