Simple and blocked randomization
Straightforward allocation for standard parallel-group designs.
Randomization
Randomization is how you assign trial participants to treatment groups while limiting bias and keeping your study statistically sound. Done well, it protects the integrity of your results from first participant in to database lock.
From simple randomization to complex, adaptive designs, across every therapeutic area and phase. For studies that do not randomize, the same IRT supports enrollment only.
3M+ participants randomized across 6,500+ trials delivered.
What Randomization Involves
The right method depends on your protocol, your endpoints, and the variables you need to control for.
Stratified randomization
Balancing treatment groups across key factors such as site, region, or disease severity.
Dynamic allocation and minimization
Assignment that adapts to keep covariates balanced as participants enroll.
Adaptive designs
Randomization that responds to pre-planned interim analyses, adjusting allocation, sample size, or arms as the study progresses.
Platform and master protocol designs
A master protocol that lets new sub-protocols start faster, whether that means a new population for the investigational drug or a new drug for the current population. These designs combine elements of basket and umbrella trials.
Blinding and emergency unblinding
Protecting allocation concealment while keeping a controlled, auditable path to unblind when patient safety requires it.
Where Randomization Gets Difficult
- Imbalanced groups when stratification factors aren’t planned well, weakening statistical power.
- Allocation errors or delays at the site that stall enrollment.
- Blinding breaks that compromise data integrity.
- Supply misalignment, when the randomization scheme outpaces what’s available at the depot or site.
- Mid-study amendments that force a change to the randomization design.
- Cohorts that cannot be opened when needed, or new ones that cannot be added when the protocol requires them.
How We Approach Randomization
We pair RTSM technology that supports any methodology with specialists who help you design the right scheme before you build it.
Any methodology, simple to novel
ClinPhone Pro supports designs from standard parallel-group through to complex schemes, so your randomization matches your protocol.
Stratification and dynamic allocation
Configurable to balance the factors that matter to your endpoints.
Randomization consultancy
Our clinical supply and randomization consultants help with strategy design, stratification planning, and list generation.
Controlled unblinding
Emergency unblinding workflows designed to protect the blind while keeping a safe, auditable path.
Change without a change request
With ClinPhone Pro, your team adjusts recruitment caps and controls across participant, site, country, cohort, and study levels directly, so many mid-study changes do not wait on a change request.
Which Solution Delivers It
Randomization, patient data, and supply strategy rarely sit in separate boxes during a live trial. Our three solution families work as one connected ecosystem, so a decision in one place doesn’t create a problem in another.
ClinPhone Pro
Configurable randomization for trials of any complexity.
Explore ClinPhone ProClinPhone Pro Core
Standardized randomization on proven configurations: direct enrollment, or blocked and stratified randomization with up to two treatment groups and two stratification factors.
ClinPhone Pro CoreRandomization Consultancy
Expert design, stratification planning, and IRT readiness review.
Explore Clinical Supply Management
Expert POV
Frequently Asked Questions
What's the difference between simple and dynamic randomization?
Simple randomization allocates participants independently; dynamic approaches adjust each allocation to keep the groups balanced across chosen factors as enrollment progresses.
When should I use stratified randomization?
When you need treatment groups balanced across factors that could affect your endpoints, such as site, region, or disease severity. We advise that any stratification factor used in the IRT randomization design is also defined in the protocol or adjusted for in the statistical analysis plan.
How does randomization connect to trial supply?
Your randomization scheme drives demand at each site and depot. Aligning the two helps you avoid stock-outs and keep participants on treatment.
Can I change the randomization design after go-live?
In many cases, yes. We build flexibility into the IRT setup up front, and ClinPhone Pro lets your team adjust recruitment controls and operational parameters directly, so anticipated changes do not need a change request. When an amendment introduces a design change nobody anticipated, our change request process takes over, with controls that protect the blind and the statistical plan.
Does every study need randomization?
No. Some studies enroll participants without randomizing them. The same IRT supports enrollment-only studies, with the same supply management and audit trail.
Resources
Latest on Randomization
Whitepaper
7 Warning Signs Your IRT/RTSM Provider Could Derail Your Clinical Trial Timelines
Read more 7 Warning Signs Your IRT/RTSM Provider Could Derail Your Clinical Trial Timelines
Case Study
Ensuring Trial Continuity Through Agile Supply Chain Management
Read more Ensuring Trial Continuity Through Agile Supply Chain ManagementRelated Capabilities
Talk Through Your Randomization Strategy
Tell us about your protocol, and our specialists will help you find the right approach.