ShareCRF helps you managing your Trials with Randomization requirements with our modules: Randomization and Trial Supply Management. These modules are fully integrated into ShareCRF platform, and they are entirely independent of external providers which will allow you to randomize patients following the needs of your trial thanks to the following features:
- Interactive Randomization from the ShareCRF eCRF.
- Different types of randomization available: Simple, by blocks, randomly permuted blocks.
- Stratification by age, gender or any variable from the eCRF.
- Unlimited number of randomization arms.
- Automatic and dynamic generation of the randomization sequence.
- Capable of managing blind studies.
- Automated, configurable and auditable system to reveal the blind.
- Treatment kits Trial Supply Management.
- Adaptative studies support.
With ShareCRF, you can automate and simplify the process of randomizing patients. This patient randomization takes place within the eCRF, making substantially easier and simpler to deal with studies that require randomization. Reduce costs and improve the security (potential bias and assignation problems reduced to the maximum) of studies with randomization are the main qualities of our integrated randomization system.
Configure the randomization module complying with the requirements of your study. ShareCRF supports several kinds of randomization: simple, by blocks and randomly permuted blocks. The configuration process is straightforward and can be done from our user-friendly ShareCRF visual editor. Once finished the randomization configuration, you will be able to validate its behaviour through our ShareCRF test environment.
The Randomization module will allow you to define either the stratification groups or cohorts that are required in your randomization study and the system will manage the process of randomization automatically, generating the blocks for each stratum and performing the randomization assignments according to the selected configuration.
Automatic and dynamic generation of the randomization sequence
The system generates the randomization sequence dynamically and automatically when a new patient is randomized, achieving greater security of the risks related to the disclosure of the sequence of randomization since the same is not generated in advance but is generated in real-time when required.
The randomization of the studies can be configured to achieve open-label randomization studies, as well as blinded randomization studies. ShareCRF allows you to set in detail as many user profiles as you require that will have access to the different patient’s randomization identification information, allowing you to make several configurations to define which profiles will have access to the information and which will not have access to it.
There is the possibility to configure the study to break the blind automatically from the profiles that will have this option enabled. This way, the blind revelation in critical situations can be done without human dependences, reducing the revealing time. Every single blind revelation will be audited and registered in our system, allowing us to see who has made them and when.
Trial supply management
The trial Supply management module will allow you to manage the supply amount of the treatment kits (control and treatment) for each of the sites participating in the study. The system will operate in the randomization process this information being capable of stopping the randomization process when there are not more treatment kits supplies available in the site.
ShareCRF allows adapting the parameters of the randomization study during the entire life of the study. Add or remove randomization arms in the study or even changing the properties of the randomization type, being a perfect eCRD solution for adaptive studies.