DiagnoSearch’s Interactive Web-based Response System (IWRS) streamlines and efficiently manages subject randomization including complex stratification and drug supply for clinical trials. Our IWRS Development Team, supported by Medical and Statistical expertise, can cater to simple as well as complex study designs and Drug Supply Management (DSM) requirements.
With a standard web browser, robust and customizable functionalities and a user-friendly interface, IWRS is a better choice for trial subject randomization and DSM. The system has been successfully utilized for trials conducted across geographies, phases and therapeutic areas and has accurately dispensed thousands of doses till date. Our IWRS solution is cost-effective, flexible and allows project specific customization.
System Flexibility
Open System Architecture to allow Interface / Integration
Project Customization (Stratification criteria for Randomization, Inclusion / Exclusion algorithms, visits, kit allocation, project specific adaptation of Inclusion / Exclusion criteria, in-built checks to comply with protocol design)
User access rights based on study specific role
Adjustable Inventory Algorithms
Programmable triggers for re-supply
Access activation/deactivation with the click of a button
Multiple user access functionality
Real-time customized email alerts at each critical step for each subject
Data Change Forms for clean and correct data capture and reconciliation with eCRF
Transparency and maintenance of complete audit trail
Key Functions:
Screening and Randomization:
Subject Registration
Eligibility Verification
Randomization based on protocol design and stratification criteria
Visit window enforcement check
Drug Supply and Inventory Management:
First Expiry First Out
Subject Visit and Dosing Requirements
Kit allocation based on dose calculation
Optimal inventory to minimize wastage
Drug Supply forecasting
Inventory management at each level i.e. depots and sites
Low inventory alerts
Provision to segregate kits as quarantined or damaged
Pre-defined triggers for re-supply
Investigational Product Reconciliation (received, dispensed, unused, returned)
Tracking of shipment turnaround time (from depots to sites)
Emergency Code Break:
Subject emergency unblinding (by authorized personnel)
Review & Reporting:
Customizable dashboard for real time summaries and reports
Ad hoc repots as per client requirements
Training and Support Services:
Project Specific IWRS User Manual
Face-to-face / web-based training
Helpdesk support via email & telephone