Accurate randomization forms the backbone of any clinical trial. Manual processes used to create randomizations are labor-intensive and prone to human error. Flexrandomizer provides a robust platform to create randomizations securely and efficiently, even for the most complex trial designs. The software can be deployed by sponsors as a standalone tool, or as part of an Independent Randomization Center service.
FlexRandomizer transforms the traditional randomization specification form into an intuitive, ‘point and click’ interface that is accessible from any web browser. The user-friendly tool facilitates fast adoption by statisticians, simplifying the development of randomizations for even the most complex trials.
Secure randomization is critical to ensure the validity of your clinical trial. FlexRandomizer provides role-based access, cast-iron firewalls, and controlled log-ins to guarantee the compliance of blinded functions.
The software maintains a full audit trail of user actions, system actions, and configuration changes to ensure the process is fully transparent. The workflow is designed to dramatically reduce the potential for manual error with dummy lists for QC and final approval generated and saved directly within the system.
FlexRandomizer incorporates a broad spectrum of randomization elements (including cohorts, treatments, mask ID, stratification) to encompass the range of specifications required in clinical development today, and accommodating both subject and package kit randomization lists.
The modern clinical trial involves multiple third party vendors with different requirements for blinding. FlexRandomizer provides the functionality to extract multiple variations of the randomization list to meet this range of role-based requirements. i.e. the main list for an IVRS vendor, and masked list for a lab vendor.
FlexRandomizer saves time for statisticians and programmers writing SAS programs for randomization, freeing them for more strategic activities and reducing the potential for human error.
The system accommodates the easy addition of meta information, saving the end user time in producing manual descriptions.
Sponsors have the option to adopt FlexRandomizer as a centralized solution and make time savings involved in a standard process.
The validity of a randomized clinical trial ( RCT) relies on reliable, error-free randomization. FlexRandomizer provides a robust platform to create randomizations accurately and simply even for complex trial designs. With role based requirements, cast-iron firewalls, breadth of functionality and an intuitive interface, FlexRandomizer ensures the security, efficiency, and accuracy of the randomization process.
Blog: The Role of the Independent Randomization Center.
