A global leader in precision medicine is focused on developing CAR T cell therapies that offer cancer patients significant benefits over standard treatments.
Operational Needs
The cell therapy developer has an extensive pipeline of CAR T treatments with its lead program recently entering pivotal trials. It wanted to move off of Excel-based batch data management to a centralized database to accelerate process verification with workflows and a single version of the truth.
Evaluation Process
The company had already contracted a third-party database developer to create a custom batch data management solution before consideration of a commercial product. However, it quickly recognized the custom database solution would be too rigid for its growing business needs and turned to Skyland Analytics.
Why Skyland PIMS?
The following were reported as top value props:
- Repository – The cell therapy developer was specifically looking for a database solution to manage batch data and was impressed with the flexibility of the PIMS™ data structure and front-end interface.
- Workflow – The primary selling point for PIMS is automated batch data QC, approvals, and persistent audit trails.
- Integration – Integrating PIMS with the company’s MES batch data acquisition system further streamlines batch data review. Their scopes of data integration focus on: 1) rapid data video process into visualization tools to monitor how each batch is behaving, and 2) continuous batch data review to see if changes have been incorporated.
