Randomization and Trial Supply Management

By combining IDDI’s randomization and trial supply management (RTSM) know-how and statistical expertise, with MENTOR industry-leading RTSM solution, IDDI manages your randomization and supply management, ensuring your study is reliably and efficiently configured, securing result integrity, and maximizing your chances of approval.

End-to-End Clinical Trial Randomization and Supply Services

Our RTSM statisticians are involved in your study from start to finish, providing the most appropriate randomization methods, clinical trial supply management, and 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 revalidation 
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

Mentor: Randomization and Trial Supply Management Software

Seamlessly integrated with ID-base and RAVE EDC, Mentor RTSM platform not only ensures the scientific integrity and operational efficiency, but also supports adaptive designs, reinforces regulatory compliance, improves participant experience, and promotes cost-effectiveness.

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Why You Need a Biostatistics-Driven RTSM System

Our biostatisticians work as a unified team with our RTSM specialists to provide a configurable and customizable end-to-end randomization and trial supply management system that:

Minimized bias: Statistically driven algorithms ensure unbiased allocation of participants to treatment arms, crucial for the validity of the trial 
Stratified randomization and covariate balancing: Advanced statistical methods can handle stratification and balance covariates across treatment groups, addressing potential confounding factors and reducing variability in outcome measures 
Dynamic allocation: Adaptive randomization techniques, such as minimization, can be employed to dynamically balance groups based on key characteristics, improving study power and efficiency

Automated processes: Automation reduces the risk of human error in randomization and trial supply management, leading to higher data quality 
Real-time data access: Statistically driven RTSM systems provide real-time access to data, enabling timely decision-making and ensuring data integrity through continuous monitoring

Flexibility for mid-trial adjustments: Adaptive trials, which may involve changes in design or procedures based on interim data, are supported by RTSM systems with statistical algorithms that can accommodate these adjustments without compromising the study’s integrity

Predictive resupply: Algorithms can forecast the demand for trial supplies at each site, reducing waste and ensuring that critical medications or devices are always available
Temperature-controlled: Track your drug temperature continuously throughout the clinical chain — from the shipment until depot and site fridges — and controlled against your drug stability data

Participant retention: By efficiently managing trial supplies and ensuring equitable treatment allocation, statistically driven RTSM systems can contribute to participant satisfaction and retention 
Personalized medicine support: These systems can manage complex randomization schemes in trials targeting specific genetic or molecular profiles, facilitating research in personalized medicine

Drug accountability: Drug Accountability Records, required by the U.S. Food and Drug Administration (FDA), help make sure that a clinical trial is done safely and correctly
Transparent reporting: The statistical backbone of the RTSM system enables transparent and reproducible reporting of randomization procedures and trial supply management, critical for regulatory submissions and scientific publications 
Audit trails: Comprehensive audit trails generated by the RTSM system help ensure compliance with regulatory requirements, facilitating audits and inspections

Resource optimization: By reducing waste of trial supplies and improving the efficiency of trial operations, statistically driven RTSM systems can significantly lower the overall cost of clinical trials 
Data-driven decisions: The ability to make informed decisions based on real-time data and statistical forecasts can prevent costly delays and modifications 
Interim analysis facilitation: The system can support interim analyses by providing accurate and up-to-date data, essential for decision-making regarding the continuation, modification, or termination of the trial

Improving Speed & Quality With the ONLY Biostatistics-Driven Randomization and Trial Supply Management Solution

End-to-End Clinical Trial Randomization and Supply Services

Mentor: Randomization and Trial Supply Management Software

Why You Need a Biostatistics-Driven RTSM System