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Clinion - Randomisation (IWRS/RTSM) & Trial Supply Management System
Integrated solution to manage study randomisation and IP supply management
Integrated eClinical tools to manage randomisation & supply management
Clinion offers a full-featured Interactive Web Response System (IWRS) consisting of study randomisation, trail supply management, subject enrolment, subject unblinding and alerts and notifications.
The system is 21 CFR part 11 compliant and is available both as a stand alone system and integrated with Clinion EDC
Study Randomisation
- Open label, Single & Double Blind
- Central / Site Level
- Create study, site, investigator
- Upload MRL
- Enrol Subject
- Un-blind subject
- Alerts & Notifications
IP Supply Management
- Upload Kit Code List
- Depot & Sites Management
- Stock Issue, receipt, transfer, return
- Inventory threshold
- Kit allocation
- Re-assign Kit
- IP Retention, Quarantine
- Subject Visit Management
- Manage courier, temperature loggers
- Alerts & Notifications
Key features
Clinion IWRS has been designed to work as a stand alone system, used independently or as a system integrated into Clinion EDC or any third party EDC.
Clinion IWRS features are:
- Create study and set up sites and users - Role based access control
Upload MRL to set up randomization schedule
- Simple, block and stratified randomization - Open Label, Single and Double blind randomization - Site / Central randomization
Enroll subject, randomize and assign kits to subject
Depot & Site Inventory management - Issue, receive, transfer, indent, quarantine, IP retention and temperature excursion
Fully integrated with Clinion EDC: Link IWRS study to EDC Randomise and enrol subject from EDC Assign kit Re-assign kit
Alerts & notifications on Enrolment, kit assignment and all steps of the inventory management process
- Audit log and Activity log - Un-blind subject - receive alerts and save/print pdf
Comprehensive Reports covering subject enrolment, randomisation, inventory, stock issue, stock receipt, kit status etc
FDA 21 CFR Part 11 compliant with complete audit trail
EDC Integration
- Clinion IWRS can be integrated into 3rd party EDCs via APIs.
- Integration process:
- Create Study in IWRS
- Upload MRL
- Create Study in EDC
- Link IWRS study to EDC study
- Create sites/ users. Same is pushed to IWRS
- Set up screening forms in EDC
- Set up factors in EDC
- Create kit assignment forms in EDC
- Publish study
- Integrated product
- Subject enrolment and randomisation
- Randomisation no is fetched from IWRS MRL and displayed in EDC
- On kit assignment
- Kit ID is fetched from site inventory and displayed in EDC
- Kit can also be reassigned
- Subject enrolment and randomisation
Integration with Clinion EDC
Clinion IWRS can be used as a stand alone system or integrated with Clinion EDC.
The integrated system works seamlessly allowing users to enrol subjects in EDC and randomise them.
Stratification factors can be defined in the EDC.
Randomised users receive a randomisation no from the IWRS. If the study is an Open Label or Single blind study, the treatment arm is also fetched from the IWRS and displayed in the EDC
Randomised users can be assigned kits in the EDC. Kit assignment can be configured in the EDC along with the eCRF creation. The IWRS checks for inventory at the sites and sends kit no to the EDC for assignment to the subject at various intervals as defined in the EDC.
Sites and users created in the EDC are pushed to the IWRS for trial supply management.
Easy to Set up
Clinion IWRS and Supply Management solution is easy to set-up and use.
The intuitive interface allows users to set up randomisation and inventory management with just a few clicks.
The whole system can be set up and made operational is a few hours!
Try Clinion IWRS for yourself
