Randomization & Trial Supply Management

Configurable Randomization and Trial Supply Management System (RTSM)

The ONLY BIOSTATISTICS-DRIVEN RTSM

Almustat 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 DESIGN	STUDY-SET-UP	STUDY 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)

FAST DELIVERY

Timelines ranging from 4 to 7 weeks

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

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

IRT reporting capability and ability for site users to access data within UI
Flexible reporting options

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

Real-time integration with IDDI EDC system (ID-base) and Medidata Rave
Interoperable with any third-party system such as EDC and CTMS

COMPLEX TRIAL SUPPLY ALGORITHMS

Various trial supply strategies per site
Variable dosing schemes
Scheduling of patient visits