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IWRS



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

 

 

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