OCELLOS for Treatment Centers
Supporting Traceability, Compliance and Scalable Cell & Gene Therapy Operations
Clinical sites play a vital role in the delivery of advanced therapies: connecting patients, collection teams, logistics partners and manufacturers. Yet many sites face rising operational pressures: FACT (Foundation for the Accreditation of Cellular Therapy) accreditation requirements, funding constraints, increasing therapy volume and the growing burden of managing multiple digital systems.
TrakCel’s OCELLOS provides a unified, site‑friendly platform designed to simplify operations, ensure compliance, reduce risk and streamline workflows across all autologous and allogeneic therapy programs. Whether supporting commercial therapies or advancing site‑led research programs, OCELLOS, with its unified access experience- Gateway- helps clinical sites reduce operational burden while confidently and efficiently managing growing therapy volumes.
Why Sites Need Support Today
FACT Accreditation Requirements
FACT accreditation for CAR‑T therapies requires sites to demonstrate end‑to‑end traceability, custody controls and documented handovers. OCELLOS enables sites to meet these expectations reliably, with automated interactions:
- Timestamped custody handoffs
- Multi-factor authentication for enhanced security
- Documentation trails ready for audit
- Consistent, validated processes across teams
Compliance becomes a natural by-product of using the platform.
Increasing Operational Complexity
Sites manage internal workflows related to COI/ COC recording that often span multiple departments:
- Apheresis/ collection
- Cell therapy labs
- Infectious Disease Control (IDC)
- Cryogenic storage units
- Reinfusion and treatment teams
OCELLOS supports this entire internal journey, mirroring the clinical reality of how cells move through the hospital- reducing risk and synchronizing teams.
Budget Sensitivity
With federal funding pressures increasing, sites need solutions that help them scale without adding administrative burden or additional headcount. OCELLOS delivers efficiency through:
Automated workflows
Reduced manual data entry
Clear, guided steps for every user
These efficiencies translate to tangible cost savings and faster therapy turnaround times.
How OCELLOS Supports Site Workflows
OCELLOS is designed to meet sites where they are- clinically, operationally and digitally. At the foundation of this support is Gateway, the unified access layer that gives sites one entry point, one interface and one streamlined experience across all therapy programs. By combining end-to-end workflow management with this simplified access experience, OCELLOS removes friction, reduces training burden and helps teams scale safely across growing therapy programs.
1. End‑to‑End Traceability & Custody Control
OCELLOS provides real‑time traceability from the moment a sample is collected, through courier handoff, manufacturing, return shipment and reinfusion. This includes:
- COC/ COI verification
- Timestamped custody handovers
- Integrated courier labeling and documentation
- Detailed audit log of all activities and users
Together with Gateway’s consistent login and navigation experience, staff access traceability tools quickly and reliably, with fewer clicks, fewer portals and reduced risk of error, and can demonstrate FACT compliance with confidence.
2. Internal Site Workflow Support
OCELLOS maps directly onto existing hospital processes, supporting COI/ COC activities across:
- Material collection: Apheresis, Biopsy, Bone Marrow etc.
- Transfer to on‑site labs
- Outbound courier coordination: automated courier booking and tracking
- Return‑to‑site tracking for infusion
- Patient scheduling and care coordination
This makes the system highly transferable and intuitive for site teams. Gateway strengthens this further by providing one familiar access point to these workflows across all therapy programs and third-party portals. Staff no longer need to remember multiple URLs, passwords or layouts, reducing operational drag and improving consistency across teams.
3. Reduced Operational Risk
By combining controlled workflows with a unified access experience, OCELLOS reduces the risk of:
- Documentation or transcription errors
- Mislabeled or mishandled materials
- Missed or delayed handoffs
- Lost communication between teams
- Inconsistent site processes
Reliable digital coordination helps protect both patients and staff. Gateway contributes to risk reduction by decreasing portal fatigue and helping teams navigate processes in a predictable, repeatable way.
4. Support for More Therapy Programs – Without Extra Burden
As therapy volumes increase, OCELLOS enables sites to scale capacity without expanding administrative headcount.
OCELLOS enables sites to manage more programs through:
- Automation of key operational tasks
- Standardized workflows across therapies
- Fewer manual systems and spreadsheets
- Centralized reporting across all therapies for improved management
- Gateway: one landing page and one interface for all programs
Together, these capabilities allow sites to add new therapies efficiently while maintaining quality and compliance.
5. Enabling Research Programs & Future Commercialization
Many oncology centers of excellence run research programs that evolve into commercial therapies. OCELLOS supports this journey by providing:
- A scalable digital backbone for research operations
- Workflow and data structures aligned to regulatory expectations
- Support for IND and early‑commercial readiness
- Infrastructure that grows as programs become marketable
Sites gain a partner that grows with their ambitions. Gateway ensures researchers and clinical teams can access all relevant systems through a single, intuitive entry point, reducing onboarding and accelerating program growth.
Why Sites Choose OCELLOS
And at many leading oncology centers, TrakCel is already known and trusted, making adoption smoother and reducing change‑management friction.
Designed for Sites. Built for Patient Safety. Ready for the Future of CGT.
OCELLOS enables clinical sites to operate more safely, efficiently and confidently across all therapy programs- while preparing them for future growth and commercialization opportunities.
Ready to Transform Your Site Operations?
Take the next step towards efficiency and compliance.
Request a Demo today to learn how TrakCel can empower your site.