IWRS

Patient Randomization/IWRS Software

Dacima’s Randomization module provides a powerful and flexible state-of-the-art web patient randomization software application (IWRS) implemented and fully integrated into our Clinical Suite for clinical trials which allows you to configure your patient randomization process and set up your enrollments/eligibility form(s). Our software allows you to define the features needed for your clinical trial patient enrollment and randomization process.

Features

  • Stratification options.
  • Blinded or unblinded options.
  • Choice of randomization methods (including simple randomization, block randomization and permuted block randomization).
  • Minimization functionality.
  • Setup of enrollment/eligibility form(s) for screening and determination the subject eligibility with validation checks.
  • Configuration of inclusion and exclusion criteria.
  • Automatic email notifications when the patient is randomized.
  • Randomization status tracking and patient enrollment status tracking.
  • FDA 21 CFR Part 11 compliant with complete audit trail.
  • Single stage enrollment allows randomization after completion of an enrollment/inclusion form.
  • Multi-stage enrollment allows multiple enrollment/inclusion forms to be used (e.g., screening form followed by an eligibility form).
    Randomization proceeds after the last enrollment form/step is completed.
  • The software allows you to run simulations during development.
  • Patient management and status tracking features
  • Built-in reports and data querying capabilities
  • Data export features.
  • Drug/device allocation and management (Supply Management module)

Easy to setup

Using a user-friendly graphical user interface (GUI) you can easily configure you randomization process and setup you enrollment/eligibility form(s) without the need for any programming expertise. Easily design your enrollment form, create validation checks and eligibility rules, and configure your patient ID format and more by simply activating the properties you need. Setup a single enrollment form or if your study requires steps or stages for patient enrollment you can configure multiple enrollment form.

Easy to Use

Easily randomize patients with only a few clicks by simply completing web enrollment/eligibility form(s). The software checks the patient’s eligibility criteria and notifies of the treatment allocation.

Role-based user access allows you to manage different levels of access for trial coordinators, investigators, nurses, monitors and biostatisticians. Coordinating centre can manage patient randomization or for multi-centre trials, patient randomization can be delegated to participating centres. Automatic email notifications and a powerful subject management screen allows you to track the randomization process and manage your patients.