TrakCel System Implementation (SI) & Digital Transformation Services
Strategic Expertise for Advanced Therapy Operations
Therapy developers face increasing complexity as programs scale from clinical to commercial. TrakCel’s SI & Digital Transformation Services were built to support therapy manufacturers at every stage- whether they are implementing OCELLOS, extending their digital ecosystem or requiring guidance beyond our product offering.
Our digital transformation team combines deep industry experience with proven frameworks, accelerators, and data‑driven insight from multiple global implementations. No matter where you are in your operational journey, we help you design, build and optimize processes and technology that support safe, timely and scalable therapy delivery.
Three Engagement Pathways
TrakCel’s SI & Digital Transformation Services support organizations with varying needs and levels of operational maturity. Engagement typically aligns with one of three scenarios:
1.OCELLOS
We provide full system implementation (SI), configuration and onboarding services- ensuring OCELLOS aligns with the therapy’s protocol, workflow and operational model.
OCELLOS can be offered with different levels of configuration:
2. OCELLOS with SAP CGTO
OCELLOS has integrated with SAP’s Cell and Gene Therapy Orchestration (CGTO) module to combine best practices and create a seamless solution for the industry. The integrated platform provides best-in-class and most widely used HCP portal with SAP as the backbone for all your CGT needs.
Value:
- Consistent experience for sites whilst managing complex business rules behind the scenes
- Order intake, management and invoicing made simpler
- Real-time updates across the entire ecosystem with exception handling
- Improved data governance and master data management
- Out of the box compliance and audit readiness
The above outlines the existing architecture that has been established with SAP CGTO. This allows the manufacturers to further build new services and orchestrate supply chains across multiple products & territories.
3. Wider Transformation Services
TrakCel has extensive experience offering standalone digital transformation services to support operational readiness, technology strategy, process design, quality and compliance.
Where TrakCel’s Digital Transformation Services Fit In
Digital Transformation is even more valuable when organizations face challenges beyond the core OCELLOS platform.
This often includes:
- Preparing for commercial scale
- Designing future‑ready technology architecture
- Integrating systems across a broader ecosystem
- Building internal operational capability
- Optimizing cross‑stakeholder processes
- Strengthening quality management and compliance functions
These services are particularly targeted at advanced therapy manufacturers seeking structured expertise during pivotal growth phases.
TrakCel’s Four Service Areas
TrakCel’s digital transformation offering is built around four specialized domains that support both clinical‑stage and commercial organizations. Each area can be delivered independently or as part of a larger consultancy program.
1. Commercial Launch Support
Supporting the transition from clinical operations to commercial launch
As therapy programs mature from clinical to commercial, operational requirements change dramatically. We help organizations identify the structures, processes, teams and technologies needed to scale successfully.
How we support you:
- Site onboarding & planning – Site training, ad-boarding and SOP discussions
- CRM for commercial operations to track and manage site onboarding – ready template to speed-up launch timelines
- Commercial readiness planning
- Network of distributors, speciality pharmacy and sites
- Training management and LMS for external stakeholders
- Ready data templates for site onboarding
- IT risk and security assessments completed for more than 200 sites
- Training of key people and maintaining an LMS for all users
- Designed & established SSO connections with all leading sites of care with CGT Gateway for faster onboarding
2. Building a cohesive, future‑proof digital architecture
TrakCel helps you to evaluate your existing technology stack, identify gaps and define a roadmap that supports your clinical and commercial objectives, while optimizing the processes that underpin clinical and commercial success. Our team supports vendor selection, system integration, workflow redesign and the implementation of best-practice frameworks to reduce manual effort and improve cycle times.
How we support you:
Technology Architecture
- Assessment of existing systems and capabilities
- Identification of technology gaps
- Digital ecosystem design
- Vendor and system procurement support
- Design, implement and manage integrations
- Custom development, reporting and dashboards
- Tableau or Data-lake integration
- Consolidation into a single source of the truth
Process Optimization
- Workflow mapping and analysis
- Best practice benchmarking
- Scalable process redesign
- Failure Mode and Effects Analysis (FMEA)
- IT project and program management
- Optimization of multi-stakeholder touchpoints
Examples of technology roadmap engagements.
- Commercial autologous – Cell therapy company developing treatment for renal incontinence. We designed a complete architecture for the commercial launch and integrated with 3PL and courier providers
- Matched allogeneic program – Developed an HLA matching algorithm and order management to support the commercial launch. This included integrating with NMDP and MS Dynamics (ERP)
- Commercial CAR-T: Designed and delivered an order management solution consisting of Healthcloud, OCELLOS and SAP
3. Patient Services Technology Implementation
Accelerated deployment of patient and product management systems
Our team brings deep experience in designing and deploying patient care solutions including case management & Therapy Command Center solutions for advanced therapies. The Therapy Command Center consolidates data from OCELLOS or other systems to provide therapy operations teams with complete visibility across the patient and product lifecycle.
Using established frameworks and accelerators, we guide organizations through efficient and compliant system implementation.
How we support you:
- Requirements and workflow definition
- Solution configuration and validation
- Data migration and integration support
- User adoption and change management
- Dashboard requirements and design
- KPI and alert configuration
- Integration with upstream and downstream systems
- Operational playbook and best‑practice setup
For Commercial CGT Manufacturers, TrakCel can streamline site onboarding and expedite the time to activate a site by 30-40%. Proactive tracking and monitoring of patient journey can transform operations, ultimately getting sites active and placing orders faster!
TrakCel brings Manufacturers one central platform to manage all sites; track products and shipments and centralize all the communication through cases.
For Phase 2 or Pivotal stage companies, TrakCel can streamline clinical operations with effective communication across stakeholders; track and monitor shipments and set the stage for commercial sites.
4. Quality & Compliance
Providing expert quality leadership where teams need additional support
Not all organizations have dedicated in‑house quality and compliance resources. TrakCel’s specialists can help establish a robust quality framework aligned with regulatory expectations.
How we support you:
- Quality system setup and documentation
- SOP development and refinement
- Compliance gap assessment
- Audit readiness and inspection support
- Computer system validation
Why TrakCel?
Deep Industry Expertise
Our experts bring hands‑on experience across clinical and commercial advanced therapy programs. In collaboration with our clients’ commercial teams and partners, we have experience of delivering multiple commercial launches.
Proven Frameworks and Accelerators
Structured methodologies reduce implementation time and risk.
End‑to‑End Operational Insight
We understand both the technology and the real‑world workflows that advanced therapies rely on.
Flexible Engagement Models
Support tailored to your needs, whether for a single workstream or a full strategic partnership.