Randomization & Trial Supply Management

Configurable Randomization and Trial Supply Management System (RTSM)

The ONLY BIOSTATISTICS-DRIVEN RTSM

IDDI uses Mentor RTSM system (powered by Sitero) because the solution allows faster deployment of your studies. It also manages mid-study changes more efficiently and with less effort.

By combining Mentor RTSM know-how with IDDI’s statistical expertise, we ensure that your studies are configured in the most reliable and efficient way, securing your trial integrity.

AGILE – CONFIGURABLE & CUSTOMIZABLE END-TO-END RTSM SYSTEM ACCELERATING THE DEPLOYMENT OF YOUR STUDIES


Seamlessly integrated with ID-base and RAVE EDC system, Mentor Randomization and Trial Supply Management System (RTSM) platform is highly configurable and customizable allowing a fast set-up of critical features such as randomization, treatment allocation and trial supply inventory.

Our biostatisticians work hand-in hand with our RTSM team to provide the most appropriate randomization methodology and follow-up.

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THE ONLY BIOSTATISTICS-DRIVEN RTSM

Our statisticians are involved from start to end to provide the most appropriate randomization methodology and follow up.

STUDY DESIGNSTUDY-SET-UPSTUDY FOLLOW UP
The biostatistician:
• Defines the randomization method in the protocol
• Defines the stratification factors in the study protocol, with a medical expert
• Runs random simulations to see the distribution of the subjects per stratification factor		• Randomization algorithm re-validation
Ensures correct implementation of the randomization based on the protocol
• Drug kit allocation validation
Ensures correct allocation of drug/dose based on the assigned treatment group & the defined schedule in the protocol		• Randomization
balance check

• Drug kit allocation accuracy check

KEY BENEFITS OF MENTOR – RANDOMIZATION & TRIAL SUPPLY MANAGEMENT (RTSM)

Randomization and Trial Supply Management
Fast Delivery

FAST DELIVERY

  • Timelines ranging from 4 to 7 weeks
Randomization and Trial Supply Management

CONFIGURABLE & CUSTOMIZABLE

  • Fast implementation of protocol amendments.
  • Easily support all your protocol designs
  • Adjustable throughout the study with no downtime
  • Advanced features to support the most complex protocols
  • Single sign-on to access multiple studies, different profiles per user and per study
  • Provides real-time information to Sponsors, Monitors, Investigators and all trial participants
Biostatistics Driven RTSM

BIOSTATISTICS DRIVEN RTSM

  • In-house biostatisticians & Randomization Teams working together to provide the most appropriate randomization methodology & follow-up ensuring that studies are configured in the most reliable and efficient way.
Reporting

REPORTING

  • IRT reporting capability and ability for site users to access data within UI
  • Flexible reporting options
Supports All Types of Randomization Scenarios

SUPPORTS ALL TYPES OF RANDOMIZATION SCENARIOS

  • Randomization schedules (fixed or variable block sizes, static or stratified)
  • Covariate adaptive randomization or stratification
  • Permuted block randomization
    • Centrally read
    • Pre-stratified blocks
    • Dynamically stratified blocks
    • Responsive adaptive randomization or dynamic randomization(minimization)
  • Open enrollment (treatment group assignment without randomization)
  • Branching enrollment (randomization and open-enrollment combination)
  • Re-randomization (using permuted block randomization or dynamic randomization)
Integration with EDC

INTEGRATION WITH EDC

Complex Trial Supply Algorithms

COMPLEX TRIAL SUPPLY ALGORITHMS

  • Various trial supply strategies per site
  • Variable dosing schemes
  • Scheduling of patient visits
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131
Randomization systems implemented
2648
centers
35755
patients

Learn on our EDC Solution