Randomization and Trial Supply Management System

Our RTSM combines ITRS (via text message), IWRS (via web) and IMRS (via mobile). It is a comprehensive system for managing the subject registration, screening, enrollment, randomization, and study supply distribution. The system supports different randomization schemes, tracks, and reports on enrollment progress.

  • Flexible Patient Screening and Enrollment Process – The system can be easily configured to fit a variety of enrollment procedures according to sponsor’s specifications. For example, screening–>sponsor approving–> randomizing–>notifying pharmacy for drug dispense.
  • Multiple randomization schemes – In addition to the standard static block randomization, the RTMS features advanced and innovative randomization schemes, including:
    • Dynamic randomization – Minimizes imbalance between treatment arms cross all strata.
    • Adaptive randomization – This method can accommodate study design changes during the study. For example, treatment arms with unfavorable results are dropped.
    • Competing randomization – An innovative randomization algorithm which enable trial to achieve randomization goal and minimize study drug inventory. Therefore, the cost for study drug can be significantly reduced.
  • Multiple protection of blinding – In addition to the standard double-blind method, the system adds an additional layer of partial blinding between drug supply and pharmacy. This allows more effective prevention of accidental unblinding.
  • Live Data Simulation – The system allows user to simulate live patient enrollment and randomization procedure according to study specs. This unique feature allows user to validate the enrollment and randomization process before system launch.