Clinion IWRS/RTSM

Randomisation and trial supply management

Manage patient randomisation, drug allotment and inventory in your clinical trials

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

Solutions designed for your unique needs

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.

- 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

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