STEMSOFT, the leading provider of cellular therapy software solutions, offers full support to electronically document all of your standard of care, IEC/CAR-T, and research work regardless of phase.
STEMSOFT provides you with a toolkit to electronically document the full lifecycle for these data including:
- Patient and consent tracking
- Apheresis collection, traceability, and ISBT-128 labeling
- Sponsor information
- Materials management (both internal and external)
- Chain of custody
- Processing and manipulations, including rescue cryopreservation of excess cells
- Shipment and logistics to Contract Manufacturing Organization (CMO)
- Receipt, quarantine storage and release of the CAR-T product from the CMO
- 21 CFR Part 11 compliant electronic signatures and audit trails
- Clinical outcomes and engraftment
- Adverse events, adverse reactions and Occurrences
- Analytics and data visualizations
The STEMSOFT platform offer the toolkit needed to support the accreditation and regulatory frameworks affecting the cellular therapy field both today and in the future. Our proprietary Jump Start Implementation Program can help your team get up and running quickly with a proven solution including:
- Standardized, scheduled training
- Access to a training site to practice at your pace
- Access to industry standard workflows
- Sample process documents to help organize your laboratory processes
- Sample Standard Operating Procedures
- Related supporting documentation for accreditation and regulatory compliance
Complete the form below to find out more on how STEMSOFT can help you take control of your CAR-T processes today.