“Zero Bias- All Random, No Bias” is a web based randomization application developed by Kreara for simple and effective randomization of Clinical Trials. Its flexible design comes with a preloaded list of Stratification variables. During system setup, we can select the required variables from the list. Then the randomization window will be automatically designed with these selected fields. There are three basic users of the system, namely- Administrator (Admin), Data Manager (DM) and Investigator. User access to the system is restricted with Username and Password. Admin will be responsible for User creation, section of stratification variables, Report generation etc. Using this application we can optimize the study drug stocking without ‘Stock Out’ problems.
The system works on the basis of a randomization list. Administrator of the system will upload the randomization list which is approved by Senior Statistician at Kreara. The randomization is done by the investigator; he/she will login to the system with user credentials and input the basic demographic data, Stratification Factors etc. Then the system will automatically generate the Randomization Kit Number. Protocol based built in edit checks will make sure that every data entered is clean and correct and the randomization is done properly. Data Managers can see the randomization status- Site wise or complete, by logging in to the system. After the successful completion of the randomization, the system will provide the Randomization Report (as PDF or MS Excel) to the Administrator and this export will be shared with the Client.