iClinica Solutions

iClinica system has been strategically designed to support the following functions.

Screening
The system allows the investigator to screen subjects for participation in the study. During the process of screening the system ensures that the site caps and the study caps for screening are adhered to.

Enrollment
The systems allows for the enrolment of a successfully screened subject into the study. During the process of enrolling the subject, the system ensures that the enrolment caps, if any, at the site or study level, are adhered to. Moreover, the system verifies that the subject can be randomized and if there are issues flag it during enrolment itself so that the investigator can take an appropriate decision.

Run-in
The system enables the user to perform run-in visits for trials. The user can easily configure the schedule of the run-in while also configuring if the run-in drug needs to be dispensed. The system has the ability to dispense a run-in drug to the subject if required.

Randomization
Randomization is a clinical trial design strategy used to assign participants to an arm of a study as defined in the protocol. The system supports multiple forms of randomization studies such as parallel, cohorts, cross-over, open-label, single-blinded, double-blinded and triple-blinded. The system allows checking of randomization caps at the site and study level during this process. The system also provides for dispensing of the study drug during randomization.

Drug Assignment
The system is equipped with the ability to define the drugs to be assigned to subjects on randomization and ensures that the correct drug is dispensed based on the randomization scheme.

Washouts
The system supports washout visits and ensures that appropriate drugs are dispensed during visits. The system enables the end user to define a washout prior to randomization at the end of the trial and also configure a wash out visit at the time of cross-over.

Visit Management
The system allows you to define all the visits, their order and duration in a study. This enables you to create a visit template for the study which can be used to track the orderly visits for each subject. The system also offers the provision to map the various visits and the study day on which they occur.

Inventory Management
The system is designed to configure the supply chain for the study and to set up the rules for inventory management. The supplies manager can register the threshold quantities, shipment time and minimum order for the sites and the data can be used to efficiently manage the inventory. iClinica ensures that only valid kits are dispensed at the site and the stakeholders are immediately intimated after the completion of dispensing.
The supply chain can be customized for each study differently based on the needs of the study. The user can have a combination of packaging centres, distribution centres, warehouses, depots, sub-depots and sites participating in the trial. The supplies manager at each of the centres can manage the inventory based on a set of rules. The system also allows supplies manager to intervene in special cases.
The supply managers can define for automatic ordering and supply of kits and can use various criteria based on the study requirement to ensure that the trial goals are met.

Material List/Kit List Management
The system allows you to create and maintain the kit list depending on the study configuration. The system interfaces with industry standard statistical tools for the generation of the same. The user can then review the generated list and load them into the system. The user can choose to load an externally generated list into the system.

Unplanned Visits
The system supports unplanned visits like discontinue, break-blind, remove-hold, on-hold for subject and kit re-dispensing.

Reporting
The system supports multiple reports which are comprehensive and easily interpretable in nature. These reports allow the stakeholders to make quick decisions to impact the efficiency of operations.

Biostats Interface
The system allows the bio-statisticians to create, review, approve and monitor the lists for the study. The system further allows for the trial biostatician to get the patient data to verify randomization and drug assignment.

 

 

Ask for a demo

For a demo on how iClinica can help you write to enquiries@iclinica.in
+1 (919) 238-3381