Solutions
Powerful optimization of clinical trials and supplies
Solutions
ISS Nexus
Powerful optimization of clinical trials and supplies
The ISS Nexus platform serves as a pivotal solution for pharmaceutical companies to efficiently execute and refine clinical supply processes. Its versatile architecture allows for robust connections between production, demand projections, and supply strategies. This feature enables comprehensive simulations across various levels, from individual sites to entire programs, facilitating the assessment of feasability and the enhancement of outcomes. Supply plans, once finalized, can be effortlessly integrated into trial execution through the platform's IRT module, or by incorporating data from a range of IRT systems or other data sources.
In both forecast simulation and active trial phases, ISS Nexus delivers dynamic reports and alerts. This functionality equips sponsors with real-time insights into inventory and future trends, spanning from single patients and trial sites to broader program and portfolio contexts.
Features
The Nexus Advantage
Reduce Costs
​
ISS Nexus reduces costs by optimizing inventory management and preventing stockouts or overproduction through precise forecasting. By leveraging real-time visibility across the supply chain, users can make data-driven decisions, reducing waste and unnecessary expenditures while ensuring timely delivery of clinical supplies.
Increase Efficiency
​
The platform increases efficiency by automating labor-intensive processes such as IRT builds, patient randomization, and protocol amendments. With intuitive dashboards, real-time insights, and role-based access, it streamlines trial and supply chain workflows, enabling faster decision-making and reducing manual tasks that can slow operations.
Ensure Compliance
​
ISS Nexus ensures compliance by integrating regulatory approval workflows and maintaining detailed tracking of lot genealogy and audit trails. Its built-in quality control features help organizations meet global standards such as 21 CFR Part 11 and GDPR, safeguarding data integrity and ensuring inspection readiness at all times.
Features
Forecasting
Forecasting is at the core of the ISS Nexus platform and helps users create detailed, highly-predictive models of how a clinical trial will proceed – essentially running the trial before it happens.
Unlike Excel models which can take weeks to build and then rebuilt again as assumptions change, ISS Nexus forecasts are modified on-the-fly, providing real-time analysis of the effects of proposed changes to a given trial.
Users also have the option of integrating data from 3rd party systems, enriching the capabilities and decision-making power of the ISS Nexus system.
Features
Interactive Response Technology (IRT)
Create lightning fast 1-day builds with ease, saving hours of time and optimizing trial execution.
With the ISS Nexus SaaS IRT module users benefit from features like flexible visit scheduling, inventory tracking and alerts, and advanced logic supply.
With robust features like multiple role types, protocol management, and intelligent automated shipping, users can avoid costly change orders midway through a trial.
Features
Inventory Management
We took the best features of an ERP and an MRP then rolled them into one comprehensive system for managing your clinical trial supplies.
Users can easily maintain visibility on depot & site inventory levels, monitor product temperature, and manage processes like manual shipping throughout all trial phases.
The Inventory Management system also provides users with robust handling of commercial lots, QA , and regulatory controls.
Features
Empower Your Data
Your data on demand. It's your data and at ISS we believe you should always have access to it.
​
ISS Nexus gives you..
​
• Robust, flexible, 3rd party data integration
• Works with your data to provide a comprehensive overview
and consistent reporting regardless of the data source
• Empowers users to be proactive instead of reactive with data driven reports and analytics
Features
100% Configurable
At ISS we recognize each customer has unique needs which is why we built our platform from the ground up to be highly configurable.
​
• Pick and choose functionality (Use what you need )
• Multiple workflow options (supports your personal workflow)
• Choose the right combination of services that meet your business needs
• One size doesn't fit all, Nexus aligns with customer workflows
• A platform thats as flexible as your changing needs
Features
Functionality
The ISS Nexus platform seamlessly combines powerful Inventory tracking, Trial and Supply Chain oversight, advanced Forecasting, IRT, and Portfolio Planning into one comprehensive solution, empowering clinical operations with real-time insights and streamlined workflows
Inventory
​
Depot & Site Inventory Management
Tracks inventory at depot and site levels, ensuring accurate stock levels and minimizing stock-outs.
​
Full Lot Lineage & Genealogy
Provides complete visibility into the origin and history of each lot to enhance traceability.
​
Temperature Management
Monitors and maintains proper temperature conditions to ensure product integrity.
​
Manual Shipping for IIS Phase 1 Trials
Provides flexibility in managing manual shipments for early-phase clinical trials.
​
Finished and Non-Finished Goods Tracking
Detailed tracking of finished and non-finished goods at both depot and site levels.
​
Real-Time Inventory Tracking & Alerts
Provides real-time updates on inventory levels and sends alerts for potential stock issues.
​
Production Planning by Lot
Manages production schedules for different lots with tracking across phases.
​
Shipments Management
Tracks shipment orders, manages status, and provides full visibility of goods in transit.
IRT
​
1-Day IRT Build
Reduces IRT system build time from 8+ weeks to just one day.
​
Flexible Visit Scheduling
Allows flexible scheduling and rescheduling of site visits.
​
Advanced Logic Supply Management
Uses advanced algorithms to ensure timely delivery of supplies while minimizing waste.
​
Role-Based Access
Provides tailored access for various roles (blind/unblind, supply chain, clinical ops).
​
Protocol Amendment Management
Streamlines management of protocol amendments to ensure fast and accurate implementation.
​
Intelligent Automated Shipping
Automates shipping tasks, improving accuracy and reducing manual efforts.
​
No Change Orders Required
100% configurable system, eliminating the need for change orders during trials.
Management
​
QA and Regulatory Controls
Ensures compliance with quality standards via notifications and second-user approvals.
​
MRP-Like Item Masters
Facilitates inventory planning and replenishment with item master functionality.
​
Approval Management
Enables management of production requests with tracking, review, and approval workflows.
​
Vendor Data Transfers
Facilitates data transfers from vendors, ensuring all required files for clinical trials are processed and monitored.
​
Trial and Compound Management
Allows for adding, editing, and managing trials and compounds used, keeping records up to date.
​
Depot and Site Finished Goods Management
Monitors finished goods at depots and sites, including expiry dates, received quantities, and stock levels.
​
Temperature Control and Monitoring
Manages and records temperature data for sensitive products, ensuring compliance with stability requirements.
Portfolio Planning​
​
Portfolio Version Management
Tracks multiple trial portfolios, offering detailed status updates on each version.
​
Side-by-Side Plan Comparison
Compare entire trial portfolios for better planning and decision-making.
​
Portfolio Creation
Combine existing trial versions into a single portfolio plan for comprehensive oversight.
​
Task List Management
Manage detailed task lists associated with each portfolio to ensure proper execution of all activities.
Forecasting
​
Support for Complex Trial Designs & Pooling
Accommodates diverse trial designs for accurate forecasting.
​
Trial Simulations & IRT Builds
Simulates trials and integrates with IRT for accurate management of trial logistics.
​
Fast & Accurate Forecast Builds
Advanced algorithms generate rapid and precise forecasts.
​
Side-by-Side Plan Comparisons
Allows comparison of multiple trial forecasting plans to optimize resource allocation.
​
Unified Nexus Reports
Provides real-time reports on trial data, including inventory, sites, and subjects.
​
Event-Based Triggers for Forecasting
Automates forecast updates based on predefined events, such as patient progression or study triggers.
​
Automated Dose Changing
Simulates dose changes to adjust forecasts based on new trial conditions.
​
Accurate Stockout Predictions
Predicts stockout events based on real-time data and usage.
Other Key Features​
​
Subscription Models
Offers flexible subscription options (per trial, compound, or enterprise-wide) based on organizational needs.
​
Hosting Options
Supports both multi-tenant and single-tenant hosting environments.
​
Third-Party Data Integration
Seamlessly integrates with third-party data sources to enhance data capabilities.
​
24/7 Support
Provides continuous technical support to ensure smooth operations.
​
Dashboard Management
A central dashboard with comprehensive metrics on inventory, recruitment, trial sites, and approvals, enabling informed decision-making.