We have collaborated with the Sheffield Clinical Trials Research Unit to support them with the management of data for clinical studies. Together we have developed SCRAM as a secure online platform to allow site and clinical staff to randomise participants on clinical studies, and for study teams to report on those allocations throughout the study.

SCRAM supports simple list-based randomisation, as well as minimisation to support studies with smaller user counts. Where needed, studies can be configured to use stratification, unequal intervention allocations, and multiple phases. We support open and double-blind studies, as well as emergency unblinding functionality. SCRAM can also be configured to notify relevant staff when a randomisation or an emergency unblinding occurs, and features comprehensive activity logging and audit trails.

SCRAM is fully web-based and centrally hosted, meaning that there is no need for installation of software at participating study sites; all that is needed is access to the internet through a modern web browser.

 

 

Supported Setup

  • Supported design: Working alongside the Sheffield Clinical Trials Research Unit we have years of experience supporting participant randomisation within studies.
  • Training instance: We provide a dedicated training instance for each study, allowing site staff to familiarise themselves with the workflow in a safe, risk-free environment.
  • Hosted for you: We host and maintain the system for you, with all data stored and processed within the UK - no technical knowledge is required.

Flexibility

  • Blinding and safety: Supports open trials and full double-blinding, and offers eligibility criteria checks and comprehensive audit logging.
  • Emergency unblinding: Provides a fully tracked and audited emergency unblinding process, with automatic email notifications to relevant staff.
  • Advanced methodology: Supports list-based/block randomisation, and minimisation, along with stratification and unequal allocation ratios (e.g. 2:1).
  • MAMS (Multi-Arm Multi-Stage) support: A phase-based approach allows researchers to add or drop treatment arms mid-trial with minimal disruption to existing allocations.

Access and Security

  • Access control: Access to the system is restricted by username and password, with each study team member and member of site staff having their own account.
  • Role-based permissions: Roles are study-specific and ensure that each member of staff can safely access the system without risk of unauthorised unblinding.

If you would like to ask a question about our Randomisation and Minimisation System (SCRAM) or request a demo, please contact us and a member of our team will be happy to help.