CLININFO IWRS
Randomization

Comprehensive, configurable, and validated across multiple study designs.

Advanced Designs

Support for sophisticated algorithms, multiple randomizations and minimization.

Seamless Integration

Randomize directly where data is entered - no extra steps, no extra systems.

IMP Management

System-driven control of IMP supply, expiration, quarantine, and patient allocation.

Our aim

Deliver a robust, study-proven randomization engine that is easy to configure, simple to operate, and trusted across a wide range of clinical studies.

Our offer

Flexible Randomization Lists

Generate or import randomization lists with full flexibility to match any study setup.

Advanced Stratification Options

Stratify or not, using any CRF variable, with full control over stratification rules.

Open-Labelled / Blinded

Support blinded and open-label designs, with strict access control.

Multi-Arm Study Support

Easily manage two or more arms with fully configurable allocation ratios.

Simple Change Management

Processes for safe and traceable cancellations or stratum changes.

Controlled Unblinding

Built-in unblinding module enabling immediate and controlled access.

Our aim

Support advanced study designs by enabling complex randomization logic, including tailored minimization algorithms and multi-layered randomization schemes.

Our offer

Flexible Study Designs

Support study structures with tailored eligibility rules, cohorts, and triggers.

Multiple Randomizations

Adaptive or multi-phase designs with multiple randomisations.

Minimization Algorithms

Built-in Pocock & Simon or custom minimization algorithms.

Blinding Options

Maintain full control over open, blinded, or mixed designs.

Validated Processes

Proven testing procedures to ensure each randomization behaves exactly as intended.

Audit Readiness

Each randomisation step is traced and documented for compliance and review.

Our aim

Integrate randomization directly into eCRF and study processes, preventing duplication, automating eligibility checks, reduce errors, and deliver clean, analysis-ready data.

Our offer

Single Access Point

Randomization triggered directly in the eCRF, with no extra system or workflow.

Eligibility-Based Trigger

Randomization only occurs when all study-specific eligibility criteria are met.

Single Randomization Rule

Built-in safeguards ensure each patient can be randomized only once.

Controlled Arm Visibility

Treatment arms shown strictly according to blinding rules and user roles.

Flexible Exports

Randomization lists exportable blinded or unblinded, based on profile permissions.

Dataset Consistency

Stratification factors and treatment arms automatically included in eCRF datasets.

Our aim

Provide a full-featured IMP management system to control stock, shipments, and expiration, minimizing waste and ensuring treatment availability.

Our offer

Patient Allocation

Flexible patient allocation and replacement, linked to randomization arm.

Multi-Level Stock Management

Real-time stock tracking across sites, pharmacies, and central suppliers.

Shipment Orders

Generate, confirm, and track orders from dispatch to receipt.

Quarantine Control

Isolate products pending verification or quality checks.

Expiration-Aware Supply

Automatic expiration management to anticipate risks and prevent waste.

Custom Supply Algorithms

Configurable options and fully custom workflows for complex supply strategies.

Trusted and Operational IWRS

Robust IWRS designed to handle complexity, urgency, and day-to-day study constraints.

Always-On IWRS Support

24/7 availability, proactive monitoring, and controlled interventions when it matters most.

Our aim
Ensure uninterrupted randomization and treatment availability with round-the-clock support, proactive issue detection, and fully traceable IWRS interventions.
Key Capabilities
  • 24/7 on-call IWRS support with dedicated procedures for urgent situations.
  • Proactive alerts anticipating randomization, allocation, or stock shortage risks.
  • Controlled and fully traceable IWRS interventions performed by authorized experts.
  • Rapid issue resolution minimizing operational downtime and site burden.

Fast & Proven Setup

Pre-built options designed for rapid deployment without compromising control.

Our aim
Enable ultra-fast IWRS deployment using pre-configured, field-tested randomization and IMP workflows that can be quickly adapted to study-specific needs.
Key Capabilities
  • Rapid randomization setup using pre-validated configurations and proven patterns.
  • Ready-to-use IMP management workflows adaptable to complex supply strategies.
  • Minimal custom development, reducing timelines and implementation risks.
  • Smooth study startup even under tight timelines or late protocol changes.

Trusted & Field-Tested Platform

A robust IWRS engine used across studies, backed by expert guidance.

Our aim
Provide a reliable and proven IWRS solution built on a shared, validated engine and supported by expert teams to ensure confidence from study start to close-out.
Key Capabilities
  • Shared, extensively used randomization engine with a strong operational track record.
  • Expert guidance on optimal IMP management strategies before and during the study.
  • Comprehensive validation documentation, both system-level and study-specific.
  • Risk-based validation approach ensuring robustness without unnecessary overhead.

Advanced IWRS Tools

A full set of built-in tools to manage treatments, devices, shipments, and complex workflows.

Investigator-Driven Treatment Declaration

Allow investigators to declare administered treatments directly, when system-driven allocation is not feasible.

Advanced Shipment PDF Generation

Automatically generate compliant, study-specific shipping documents to simplify logistics and reduce manual errors.

Complex Kit Management

Manage multi-component kits, substitutions, and dependencies seamlessly to support sophisticated treatment configurations.

Direct-To-Patient Shipments

Enable secure, controlled shipments directly to patients, improving continuity of care and reducing site burden.

Implant & Explant Device Lifecycle

Track implantable devices from allocation to explantation, ensuring full traceability throughout the device lifecycle.

Country-Specific Supply Rules

Adapt supply workflows to country-specific regulations and constraints, including local suppliers and central pharmacies.

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Complete Clinical Software Ecosystem

A wide range of seamlessly connected solutions to cover every aspect of your clinical study.

eCRF

Rapidly deploy and customize your study data capture.

ePRO

Capture patient-reported outcomes efficiently and remotely.

IWRS

Simplify randomization and study drug management.

CDMS

Centralize and clean study data in real time.

eTMF

Manage essential documents securely and compliantly.

CTMS

Track study progress and monitoring easily.

Regulatory Compliance

Our solution ensures full regulatory compliance, with secure, auditable, and reliable clinical data management.

FDA GCP GDPR HIPAA
ISO HDS SOC

See Your Study Come to Life

Discuss with our experts about your study, test a custom sandbox, and see how our solution can be tailored to your needs.

Request a Demo