Trials Are Complex, Your Supply Chain Shouldn’t Be
Intelligent Clinical Supply Management (ICSM) is SAP’s next-generation solution designed to transform how life sciences companies manage clinical trial supplies.
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Streamlined Clinical Trial Management and Supply Planning
Simplify Complex Study Management
Easily maintain clinically relevant parameters, support diverse study types, and seamlessly integrate with any IRT system. Streamline digital approval workflows before and throughout clinical trials.
Real-Time Planning and Forecasting
Perform precise demand calculations and simulate multiple scenarios based on projected or actual subject enrollment and visit data. Continuously compare plans against actual enrollment to optimize supply predictions, minimizing shortages and waste.
Streamline Partner Coordination
Facilitate seamless exchange and execution of subcontracting purchase orders for external clinical finished goods (CFG) production, improving collaboration with research and manufacturing partners.
Ensure Quality and Compliance
in Manufacturing
Manage medication lists for both open and blind serialized trials, including batch allocation and expiry date tracking. Support internal packaging, external labeling, and efficient shelf-life management aligned with GxP standards.
Enhance Stock Visibility and
Distribution Efficiency
Achieve detailed visibility down to site and kit ID levels. Support picking, packing, repackaging, and integrating third-party logistics through GS1-compliant interfaces.
Solution Benefits
Respond swiftly to evolving trial designs and trends with a scalable system that supports multiple clinical supply models.








Autologous CAR-T Cell Therapy for Hematologic Malignancies
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Autologous CAR-T Cell Therapy for Hematologic Malignancies
Accelerating Clinical Trials with Intelligent Supply Management
Chimeric Antigen Receptor T-cell (CAR-T) therapy involves ex vivo engineering of a patient’s T-cells to express CD19-specific receptors, enabling targeted cytotoxicity against B-cell malignancies such as
relapsed/refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma
Impact: ·
Demonstrated complete remission rates up to 80% in pediatric ALL post-single infusion; rapidly evolving into earlier treatment settings and other B-cell–driven diseases.
AAV-Mediated Gene Replacement Therapy for Spinal Muscular Atrophy (SMA)
Zolgensma® utilizes an adeno-associated virus serotype 9 (AAV9) vector to deliver a functional copy of the SMN1 gene via intravenous infusion, correcting the underlying genetic defect responsible for SMA Type 1 at the molecular level.
Impact:
Enables durable SMN protein expression with a single dose, significantly improving survival, motor development, and reducing lifelong therapeutic burden.
Enhancing Serialization Compliance with Agentic AI
Case Scenario: In life sciences, serialization requires seamless EPCIS message flow across systems like SAP ATTP, WMS, and pharmaceutical track and trace software. Any delays or system failures can halt shipments, triggering serious compliance risks. Manual exception handling adds time, increases operational strain, and delays the resolution of issues, leading to costly impacts on business operations.
Novatio’s Compliance Monitor and EPCIS AI Agent, powered by Agentic AI, offer an automated approach to managing serialization compliance. The AI continuously monitors EPCIS message flows, detects anomalies, and ensures GS1 standards are met. When issues arise, the AI auto-resolves exceptions and recommends next steps.
Impact: ·
- 50% Faster Issue Resolution: Agentic AI reduces the time to resolve serialization issues by up to 50%.
- 40% Reduction in Manual Effort: Automated exception handling and partner communication streamline workflows and reduce manual labor.
- 30% Fewer Shipment Delays: Real-time orchestration improves traceability, ensuring stronger compliance readiness and fewer disruptions in the supply chain.
Accelerating Denial Recovery with Appeals AI
Case Scenario: Healthcare providers face mounting pressure from increasing claim denials, administrative overhead, and prolonged reimbursement timelines. Manually reviewing payer denial reasons, interpreting complex guidelines, and compiling appeals from extensive medical records leads to delayed or missed appeals—directly impacting revenue cycle efficiency and cash flow.
The Appeals AI Agent addresses this critical bottleneck by automating the appeal generation process. It intelligently identifies denial reasons and the associated clinical or policy guidelines, extracts relevant segments from lengthy medical records, and generates context-aware, payer-compliant appeal letters. This ensures faster, more accurate submissions with minimal human effort—allowing staff to focus on high-value tasks while improving denial overturn rates.
Impact: ·
- Up to 60% Reduction in Appeal Preparation Time: Appeals are generated in minutes instead of hours or days, enabling faster resubmissions.
- Increase in Timely Filed Appeals: Automated processing ensures deadlines are met, reducing missed appeal opportunities.
- 2X Improvement in Denial Overturn Rates: Appeals are strengthened with guideline-aligned reasoning and medically relevant summaries.
- Accelerated Cash Recovery: Faster and more successful appeals lead to improved revenue cycle velocity and working capital health.
Agentic AI in Healthcare: Automating Denied Claims Management End-to-End
Challenge: Healthcare providers are under immense pressure from labor shortages, complex payer requirements, and limited windows to respond to claim denials. A lack of real-time eligibility checks and inefficient follow-up processes often results in unnecessary denials and delayed reimbursements. Manual efforts to resolve these denials — including long wait times with insurers and fragmented documentation workflows — lead to significant financial write-offs and staff burnout.
Solution: End-to-End Denial Resolution Powered by Agentic AI: We deployed a fully autonomous Agentic AI solution that acts as a digital agent, managing the denied claims lifecycle from start to finish with minimal human intervention.
Before care is delivered, the agent performs real-time eligibility checks and reaches out to insurance payers to obtain pre-approvals, minimizing preventable denials. This proactive step alone helped reduce initial claim rejections by over 45%.
If a denial occurs, the agent takes full ownership by reaching out to patients, providers, and insurance payers via voice or chatbot to collect all necessary information. It retrieves and updates records directly in Epic EHR, equipping hospital staff with actionable information upfront — eliminating long wait times and reducing manual effort.
Impact: ·
- 70% reduction in manual follow-up time, freeing up staff for higher-value tasks.
- 50% increase in denial overturn rates, improving claim success significantly.
- >80% accuracy in eligibility checks, documentation, and payer interactions.
- Action-ready insights for hospital staff, eliminating time spent on hold or searching systems.
- $1.2M+ annual revenue recovered through timely and complete denial resubmissions.