Features
- Enrol patients in the clinical trial
- Track the progress of trial enrolment in real time
- Manage the location of your stock
- Include your study's custom randomization algorithm
- Communication with external tools
- 21 CFR Part 11 Compliance
Our Interactive Response Technology (IRT), covers IWRS and IVRS (and the client gets to decide which modules to include when we configure their system).
It is a full fledged RTSM (Randomization and Trial Supply Management) solution that tracks your product throughout the entire clinical trial (including dispensing!).
The IWRS can be used in any type of clinical trial, including medical devices.
As a simple tool that serves the purpose of randomize patients, it is a cost-effective alternative that can be used independently of your EDC. The optional stock management module can be used to manage the location of the clinical trial medication or medical device.
- Centralizes patient enrolment
- Improves medication/medical device traceability
- Instant email notifications when a subject is enrolled
- Multiple Randomisation Algorithms: Central, site, stratified, Minimisation (Pocock-Simon)
With 24/7 availability of the service, randomization can occur any time, anywhere!
Highlights
IWRS - Interactive Web Response System
Enrol patients in the clinical trial
Real time trial and site enrolment progress
Export PDF/Spredsheet reports
Multi-language support
Email notifications on randomizations
Simple and intutive. The IWRS will allow subjects to be enrolled in your clinical trial 24/7 at an affordable price.
The IWRS can also communicate with other systems automatically (including our EDC System, allowing you to use ITClinical's IWRS tool independently while maintaining a communication with an external vendor's tool.
Stock management
Locate trial medication/devices
View their location history
The stock management is an optional module that allows you to register and track your trial stock by registering movements (shipments and returns) and see movement history in the locations involved in the clinical trial (global and regional depos and investigational sites).
Optional features within this module include the registration of orders to manufacturer, shipment/return PDF forms and location re-supply triggers.
Compliance
21 CFR Part 11 Compliant
Exportable Audit trail
Several user access levels
By complying with regulatory requirements for electronic systems, it replaces paper based records which greatly assists you to access product information and records a long time after the trial is closed while avoiding manual searches.
A flexible authentication and authorization system allows restricting access to the system and to the functionalities each user can perform.
Tailoring to your needs
We provide various deployment options, depending on your infrastructure:
Technology Transfer run system on your network
Hosted solution use system in the cloud
ITClinical can adapt its base product to meet specific requirements, tailoring the application to your needs.
Instead of offering a fully fledged solution, we try to understand what you need and provide you with a customized, cost-effective solution.
Running on Linux servers, this also means there will be no increased licensing costs.