A Unified Digital Operations Platform for Cell and Gene Therapy

Insight68 connects clinical planning, production scheduling, manufacturing execution, laboratories, quality, inventory, Chain of Identity, Chain of Custody, and time-critical logistics in one configurable cloud platform.

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A Unified, Cloud-Native Ecosystem
Unified Vein-to-Vein Platform

CGT cleanroom manufacturing with production scheduling interface

Mastering Made-to-Order Complexity

Effortlessly manage the unique requirements of personalized medicine at scale.

Proactive Resource Planning

Stop reacting to shortages. Align your clinical forecasts with real-world manufacturing limits and material availability to stay ahead of demand.

End-to-End Operational Synergy

Bridge the gap between the clinic and the factory floor. Leverage deep-dive analytics to eliminate waste, lower operating costs, and streamline drug delivery.

Achieve Lean, Resilient Operations

Eliminate the risk of material shortages and costly waste. Insight68 provides total visibility across the supply chain, ensuring site consignments are perfectly balanced against real-time demand.

Precision Kitting & Flow

Streamline your floor efficiency with optimized kitting processes that ensure manufacturing never pauses. By aligning material readiness with production schedules, we remove the disruptions that stall progress.

Dynamic Patient Orchestration

Simplify the complexity of real-time scheduling for bespoke therapies. Our platform aligns patient-specific orders with live manufacturing capacity to ensure no slot goes to waste.

Synchronized Production & Care

Seamlessly match manufacturing cadences with clinical study plans. We ensure the frequency and timing of every dose are perfectly calibrated to the patient�s treatment window.

Intelligent Logistics Command

Total oversight of the specialized supply chain. From ultra-cold chain transport to final delivery, we manage the logistics that keep life-saving therapies viable.

Securing the Chain of Identity (COI)

Protect patient safety with robust, AI-driven risk mitigation. We ensure total privacy and compliance across the supply chain while maintaining an unbreakable link between the patient and their therapy.

Guaranteed Delivery Precision

Turn logistics into a competitive advantage. Our intelligent workflows ensure that time-critical drug therapies arrive on schedule, meeting the exact clinical requirements of the treatment plan.

Hardwire GxP standards into every workflow

Our Quality Intelligence platform automates compliance, resource training, and issue tracking to eliminate manual bottlenecks.

Turn quality into a scalable AI advantage, ensuring "Right First Time" integrity and global regulatory success for your entire institution.

Review by Exception

Accelerate batch releases with "Review by Exception" and permanent audit readiness. Turn quality into a scalable AI advantage, ensuring "Right First Time" integrity and global regulatory success for your entire institution.

Unified clinical data with manufacturing and logistics

Ensures "vein-to-vein" traceability and reduced data reconciliation efforts

Accelerate study timelines with real-time logic checks and structure your data for high-impact success.

Compliance and Audit Readiness

Permanent audit readiness that minimizes regulatory risk during FDA or EMA inspections.

Unified research and laboratory workflows

Accelerates discoveries through real-time collaboration and workflows into a single ecosystem. Turn experimental data and sample tracking into a scalable AI advantage, providing a "Right First Time" foundation and a faster, compliant path from lab to market.

Unify all data with a reasoning-based AI engine

By anchoring Generative AI and LLMs to a Neo4j Knowledge Graph, we eliminate hallucinations and provide Explainable AI that mirrors your operations.

This architecture transforms real-time telemetry into prescriptive, actionable outcomes, providing the transparent ground truth needed to optimize decision-making and drive operational excellence across the entire ecosystem.

Significantly Reduce Operation Costs

Reduced waste and material shortages
Eliminate inefficient equipment utilization
Predict stock levels

Cloud Services

Configurable user workflows
Easily deploy solutions in a few weeks

On Schedule

Intelligent management of supply chain and transportation
Real-time scheduling

Simplify Operations

Automated made-to-order scheduling of personal therapies
Seamless integrated with clinical trials

Reduce Risk

Patient safety and privacy
Verify and ensure on-time delivery of treatments

Scale Confidently with Business Analytics

Actionable insights to optimize operations
Accurate prediction of production,inventory,and resource requirements
Store and analyze large volumes of data

Manufacturing Challenges: Solved.

The Unified Solution: Eliminate the friction of fragmented systems. Insight68 provides a single, AI-driven ecosystem tailored to the high-stakes requirements of Cell & Gene manufacturing.

1. Clinical & Site Orchestration

Total Enrollment Visibility: Seamlessly manage patient enrollment and clinical trial data in one place.

Decentralized Network Management: Synchronize consignment levels and inventory across clinics, hospitals, and their satellite locations.

Chain of Identity (COI): End-to-end verification for cell collection, patient samples, and incoming materials.

2. Precision Production Scheduling

Real-Time Order Integration: Schedule patient orders directly with production the moment they are placed.

Throughput Optimization: Maximize facility utilization by aligning manufacturing slots with real-time resource availability.

Predictive Resource Planning: Use AI to forecast production needs, preventing material dependencies from slowing down your timelines.

3. Smart Inventory & Lab Operations

Intelligent Kit Assembly: Automate and optimize the kitting process to ensure manufacturing-ready materials.

Unified Quality Control: Integrated management of manufacturing processes, quality checks, and clinical lab results.

Time-Critical Monitoring: Active tracking for expiry management and temperature-sensitive assets to ensure zero-waste.

1.
Schedule
Treatment2.
Collect &
Deliver3.
Activate
PBMC4.
Freeze
PBMC5.
Manufacture
Doses6.
Deliver to
Clinics7.
Administer
Doses

Logistics Complexities in
Supply Chain and Transport

Multiple form factors include mobile and tablets for ease of system access
System that integrates the supply chain and transport requirements
Integrates seamlessly with clinical trials, scheduling, and manufacturing
Complete COC, COI, and audit trails for patient safety and compliance
Workflows to ensure effective real-time logistics processes
Safe and on-time pickup and delivery of materials

Master Complex Clinical Workflows

Centralize the management of your studies and cohorts. From treatment plan configuration to site-specific oversight, Insight68 simplifies the most intricate clinical trials.

Precision Subject Management

Accelerate enrollment and simplify monitoring. Our platform provides the visibility needed to track subjects and sites with total accuracy and compliance.

Unified Site Management

Verified Patient Safety: Eliminate errors with automated patient and sample verification at the point of care.
Collection & Infusion Tracking: Digitally manage the end-to-end process of collecting starting materials and administering finished doses.
Automated Consignment: Real-time visibility into drug and kit stock levels across all clinical locations to prevent delays.

Advanced Laboratory Management

Automated Sample Processing: Standardize testing workflows to ensure consistent results and accelerated turnaround times.
Precision Inventory Control: Seamlessly track and manage lab-specific kitting and consumables to prevent disruptions in the testing pipeline.

Logistics Orchestration: Centralize courier management to ensure high-stakes therapies move seamlessly through the supply chain.
Courier Mobile Interface: Real-time mobile tools for digital signatures, geolocation tracking, and instant verification of time-critical shipments.

Integrated Manufacturing Orchestration

Strategic Resource Planning: Balance production capacity with clinical demand using AI-driven resource and material forecasting.
Unified Execution Suite: A single ecosystem for real-time scheduling, manufacturing workflows, and precision inventory control.
Vein-to-Vein Logistics: Intelligent management of the entire supply chain, from raw material transport to final drug delivery.
Actionable Analytics: Transform operational data into strategic insights to lower costs and maximize facility throughput.

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A Flexible Suite Tailored to Your Factory

Whether you need to manage your entire facility or just a specific functional area, Insight68 delivers. Our cloud-based platform is fully configurable, allowing you to deploy tools independently or in collaboration.

Total Orchestration: Manage every aspect of the vein-to-vein journey.
Modular Precision: Deploy only what you need, when you need it.
Seamless Integration: Built to work alongside your current software environment, not against it.

Clinical Trials Management (CTM)

Optimize clinical trials with real-time analytics. Our platform identifies bottlenecks early to accelerate market entry. With a patient-centric focus, we provide a secure framework for rigorous data management and safety monitoring.

Analytics Intelligence (AI)

Bridge the cleanroom and boardroom with real-time data streaming. Our AI identifies bottlenecks instantly, shifting you from reactive to predictive orchestration. Empower teams with KPI dashboards for faster strategic decisions.

IM: Smart Stock & Storage Orchestration

Insight68 turns inventory into a predictive asset. Our AI automates replenishment based on clinical forecasts, monitors environmental integrity (Cryo/Ambient), and tracks shelf-life (TOR) to eliminate waste. Optimize kitting and fulfillment.

CGT Production Scheduling Software

Insight68 resolves manufacturing complexity by balancing real-time constraints with clinical demand. Our engine automates capacity balancing, constraint-aware planning, and just-in-sequence execution to ensure peak throughput and zero idle time for high-value therapies.

Vein-to-Vein Logistics and COI/COC

Insight68 ensures an unbreakable Chain of Identity (COI) and Custody (COC) for personalized medicine. Our ecosystem automates safety protocols to track, verify, and protect life-saving therapies from collection to infusion.

Agile Manufacturing Execution

Manage the factory floor via one interface. Insight68 deploys configurable workflows and exception reporting, replacing paper with a digital thread from reception to release to eliminate friction and accelerate throughput.

Next-Gen LIMS: Streamlined Compliance

Eliminate lab bottlenecks with a flexible LIMS. Insight68 automates sample accessioning and kit management with custom workflows. Achieve end-to-end traceability and direct integration into your manufacturing and analytics ecosystem.

The No-Code Engine for Bio-Manufacturing

Bridge IT and Operations with Insight68’s no-code platform. Create custom forms and clinical apps via drag-and-drop. Built for life sciences, our interface ensures your digital infrastructure is as flexible as your science. Build, validate, and scale.

Next-Gen Equipment Logging

Eliminate paper-based risks with personalized UI and centralized logging. Insight68 tracks maintenance and events with automated deviation management thus creating a high-fidelity audit trail.

Scientific Intelligence (ELN)

Insight68 ELN unifies experiments and inventory into a compliant digital thread. Our configurable app features a text editor, spreadsheet, and whiteboard to capture structured data and manage samples, ensuring 21 CFR Part 11 readiness and AI-driven strategic insights.

Clinical Intelligence: The EDC Advantage

Insight68 EDC unifies clinical data with manufacturing and logistics. Our no-code engine builds validated eCRFs with real-time logic checks and 21 CFR Part 11 compliance. Native CGT integration ensures vein-to-vein traceability and structures data for AI-driven outcomes analysis.

Quality Intelligence: The QMS Advantage

Insight68 QMS provides a quality app for the entire business, hardwiring GxP standards into every workflow. It includes TMS, CAPA, and Supplier Management. With "Review by Exception" and native integration, we accelerate batch release and turn quality into an AI advantage.

Data Intelligence: Insight68 Sheets

Insight68 Sheets bridges spreadsheets and databases with concurrent real-time editing and 21 CFR Part 11 compliance. With database-backed integrity and cross-module syncing, it transforms raw data into a structured, AI-ready source of truth.