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 eClinical Suite for clinical trials, which allows you to configure your patient randomization process and set up your enrollments/eligibility form(s).

EASY SETUP

Working with our user-friendly Graphical User Interface (GUI) you can easily configure your randomization process and setup your enrollment/eligibility form(s) without the need for any programming expertise. Easily design your enrollment form, create validation checks and eligibility rules, configure your patient ID format and more by simply activating the properties you need. You can either setup a single enrollment form or, if your study requires steps or stages for patient enrollment, you can configure a 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.

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 determine 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 randomization after completion of an enrollment/inclusion form/question(s)
Multi-stage enrollment: randomization after the last enrollment form/step across multiple forms 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)

PATIENT RANDOMIZATION / IWRS SOFTWARE

EASY SETUP

EASY TO USE

FEATURES

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