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
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:
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.
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!