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.
Techsol partnered with Axis Clinicals to assist in various tasks required to define the system for Axis’s use. Our team analysed the system requirements, implemented the requirements, integrated instruments as required and tested the system, with associated documented evidence. The project was completed in 20 weeks from initial discovery to official deployment of the system for operational use.
- Techsol coordinated with Axis Clinicals and Foundry Health, owners of ClinSpark, through onsite workshops to understand the objectives of the project.
- We worked with Foundry Health team to understand the technical architecture, functionality, configurability, modes of maintenance of ClinSpark. Our team got trained on the system by experts at Axis Clinicals.
The efficient execution of the project brought many favorable results for the client
- Human errors were reduced by 85%
- The cost was reduced by 40%
- The amount of work was reduced by 60%