Octalsoft’s IWRS software is yet another powerful and valuable asset in the eClinical toolkit that enables sponsors to not only configure subject enrolment and randomization process but also manage global IP supply chains, using an intuitive web-browser interface. Recently coined as “RTSM” (Randomization and Trial Supply Management), the system serves a dual purpose. First, it eliminates selection-bias and limits the predictability of treatment allocation and enables treatment group balance. Second, it optimizes clinical supplies management and inventory tracking ensuring that right investigational products are available and assigned to the right subject at the right time, always.

Highlights of Octalsoft IWRS

When it comes to choosing an IWRS vendor, there are so many industry standards available. With our deep understanding of software development and insights gained from customer inputs, we highlight the following points that will help you apprehend the salient features that this platform has to offer.

Performs the core function of patient registration, enrolment, and randomization.
Implement complex randomization methodologies using validated randomization sequences.
Define randomization blocks across various strata; adjust cohorts, and of course, maintain the study blind.
Algorithm-based subject medication dosing and dispensation.
Perform inventory management, drug accountability, and drug reconciliation under one roof.
Align supply strategy to eliminate over-stock and stock-outs. Define thresholds & reorder quantities.
Automated alerts for subject status tracking and replenishment requirements.
Live dashboards & status reports for increased visibility.
Quick deployment and Integration.

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Product Overview

Simple Browser-Based User Interface (UI)

Simple UI encourages quick adoption by site coordinators and minimizes errors in data entry and IP dispensing.

Balance IP supply against Enrolment

Calculate IP requirement projections based on actual versus estimated enrollment. Pool and share supply across multiple studies, at the lot level and site level.

Emergency Code Breaking

Octalsoft IWRS’s automated code break functionality provides greater security and a superior audit trail to seamlessly manage any emergency un-blinding.

Automated Messaging

Keep the right people informed of the right information with customized, automated notifications. Depot manager and other study team members receive automated messages notifying them of replenishment requirements. Status reports keep sponsors aware of all the supply chain activities.

Inventory Tracking

Utilizing predictive ordering algorithms, gain real-time insight into your IP supply management and inventory tracking. Consider variable parameters such as shipping size, site storage limitations, near expiry products, returns, and top-ups.

Predictive Forecasting

Simply following a pre-defined site level ceiling is sometimes not good enough to trigger a resupply request. Octalsoft IWRS comes with predictive capabilities that take into account parameters such as lead delivery time for a particular distributor; and thus, prevents stock-outs when the IP is needed faster than the supply chain can manage.

Product Benefits

Faster Enrolment

With 24/7 availability of web interface, register and enroll subjects quickly into your study.

Reduce Costs

Leveraging the web reduces the trial life cycle, which saves money and delivers therapies to market sooner.

Quicker Deployment

Achieve quicker deployment for protocols requiring complex randomization designs.

Leverage Integrated Solutions

Integrate Octalsoft IWRS with other third-party data systems such as EDC, ePRO, and CTMS.

Better Statistical Analysis

Randomization improves the blinding process and limits predictability by allocating patients to study groups in an unbiased manner and better aids in statistical analysis.