Eliminating Change Orders: The Power of 100% Configurability in Clinical Trials
The Hidden Cost of Change Orders
Change orders have long been a necessary but frustrating reality in clinical trials. Every adjustment—whether a protocol amendment, a scheduling tweak, or an inventory update—typically requires vendor intervention, incurring delays and additional costs. In an industry where time is critical, waiting weeks for system updates can disrupt patient treatment schedules, delay regulatory approvals, and inflate budgets.But what if clinical trial teams could make these changes instantly, without needing external approval? ISS Nexus introduces a paradigm shift with its 100% configurability, enabling sponsors and CROs to manage modifications in real time, reducing dependencies and enhancing efficiency.
The Problem: Why Traditional Change Orders Create Bottlenecks
Change orders are often required for even minor system modifications, leading to several operational challenges:
- Delays: Vendor processing times can range from days to weeks, slowing down essential trial operations.
- High Costs: Vendors frequently charge fees for system updates, leading to unexpected budget increases.
- Inefficiency: Multiple layers of approval and documentation make even simple adjustments cumbersome.
- Lack of Flexibility: Trial teams must anticipate all potential changes upfront, which is unrealistic in dynamic clinical environments.
The Solution: 100% Configurability with ISS Nexus
ISS Nexus eliminates these bottlenecks by providing a fully configurable system, empowering trial teams to make critical updates without vendor intervention. Here’s how:
1. Intuitive User Interface for Instant Adjustments
- A no-code, user-friendly dashboard allows authorized users to modify workflows, update site settings, and adjust visit schedules in minutes.
- Instead of submitting requests to a vendor, trial teams can implement protocol amendments or logistical changes in real time.
2. Protocol Amendment Management Without Delays
- ISS Nexus simplifies protocol modifications by integrating automated tracking and version control, ensuring all updates are implemented instantly.
- Site- and country-specific variations can be adjusted seamlessly, reducing compliance risks and regulatory delays.
3. Dynamic Supply Chain and Forecasting Adjustments
- The platform automatically recalibrates supply forecasts based on real-time enrollment data, preventing stockouts and overages.
- Adjustments to resupply triggers and shipment schedules can be made without the need for costly change orders.
4. Role-Based Access for Controlled, Secure Modifications
- Configurable permissions ensure only authorized users make changes while maintaining a complete audit trail.
- Teams can define workflows that allow site managers, clinical teams, and supply chain personnel to update only their relevant sections without affecting other modules.
Case Study: Rapid Adaptation in a Phase 3 Oncology Trial
A global Phase 3 oncology trial encountered an unexpected recruitment surge at several sites. Traditionally, this would have required multiple change orders to adjust site supply plans, leading to delays and the risk of treatment shortages.
With ISS Nexus:
- The study manager updated visit schedules and adjusted recruitment limits in real time.
- Supply chain forecasts automatically recalculated based on the new enrollment data.
- Additional shipments were triggered instantly, preventing site stock-outs without vendor intervention.
The result? No trial delays, uninterrupted patient care, and substantial cost savings.
The Benefits: Why 100% Configurability Matters
1. Speed & Agility: Implement changes in real time without waiting for vendor approvals.
2. Cost Savings: Avoid unnecessary fees associated with traditional change orders.
3. Operational Efficiency: Reduce administrative bottlenecks and increase productivity.
4. Regulatory Compliance: Built-in audit trails ensure every modification is documented and trackable.
5. Trial Oversight & Control: Maintain complete visibility and control over trial operations, eliminating vendor dependencies.
A New Era of Trial Flexibility
ISS Nexus is redefining clinical trial management by eliminating the costly and time-consuming burden of change orders. With its 100% configurability, sponsors and CROs gain the power to adapt to trial complexities without delays, improving efficiency and ensuring that trials stay on track.
Are you ready to revolutionize how your clinical trials operate? Learn how ISS Nexus can help you eliminate change orders and streamline trial execution. Request a Demo Today.