RTSM SOFTWARE: RANDOMIZATION & TRIAL SUPPLY MANAGEMENT
RTSM software for clinical trials
oomnia RTSM is a Randomization and Trial Supply Management system that automates treatment allocation and blinding in real-time within a unified clinical trial software.
Unified data capture
Intelligent RTSM for clinical trials that unifies randomization and supply oversight
oomnia RTSM is the allocation and investigational product management module within the oomnia clinical trial software.
Randomization, kit distribution, and controlled unblinding operate within one structured environment, eliminating reliance on standalone Interactive Response Technology (IRT) systems and reducing synchronization risk.
CLINICAL DATA
What is oomnia RTSM used for?
oomnia RTSM integrates allocation and supply workflows to reduce cross-system reconciliation and strengthen treatment allocation control.
oomnia RTSM supports:
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Centralized randomization with block and stratified schemes
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Automated patient stratification and adaptive schedule control
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Secure blinding with controlled emergency unblinding
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Real-time Investigational Medicinal Product (IMP) inventory oversight across sites and depots
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Subject-level IMP dispensation and return tracking
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Automated kit assignment and resupply management
This ensures allocation precision, continuous supply control, and reduced operational risk.
Key Capabilities
Key capabilities of oomnia RTSM software
| Aspect | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| Treatment allocation | External engine; limited visibility; fragmented logic | Controlled, configurable randomization within a unified environment |
| Patient stratification | Limited or manual stratification setup | Automated patient stratification based on predefined criteria (e.g., site, country, age, gender) |
| Adaptive randomization support | Protocol amendments required for randomization changes | Supports modification of randomization schemes after interim analysis and sample size reassessment |
| Blinding management | Manual oversight; emergency processes outside core system | Integrated blinding with controlled emergency unblinding and full traceability |
| IMP inventory oversight | Separate inventory tracking; delayed visibility | Centralized real-time tracking across sites and depots |
| Resupply coordination | Manual forecasting and site communication | Automated reorder triggers and controlled stock transfers |
| Expiration & temperature control | External logs and manual monitoring | Built-in expiration safeguards and temperature deviation workflows |
| Audit & compliance | Multiple audit layers across disconnected systems | Unified audit trail with role-based access control |
| Reporting & data export | Limited reporting across separate systems | Integrated reporting and export capabilities for allocation and supply data |
Regulatory Readiness
Compliance and regulatory readiness
The oomnia clinical trial software is built to support regulated clinical research environments, helping biopharma teams maintain compliance, streamline documentation, and stay inspection-ready through every phase of the trial:
Aligned with GxP principles
Supports GxP-aligned processes across all clinical research operations
Supports compliance with 21 CFR Part 11
Fully compatible with 21 CFR Part 11 electronic records and signature requirements
ICH-GCP-compliant workflows and oversight controls
Workflows structured in accordance with ICH-GCP standards and oversight principles
GDPR-aligned data handling and privacy safeguards
GDPR-compliant data handling and privacy protection across all study environments
Built-in audit trails and full data traceability
Automatic audit trails and complete data traceability across all study operations
Validation documentation and continuous system compliance support
Clear validation documentation and ongoing support to keep the system compliant
How It Works
How oomnia RTSM works inside a clinical trial platform
Unlike standalone IRT systems that require separate integrations, oomnia RTSM is part of a unified clinical trial platform. This means:
No separate IRT system required
Randomization directly within the eCRF
EDC and RTSM share the same database
Drug supply tracked in real time across all sites
No manual reconciliation between systems
One audit trail across all modules
Real-time operational oversight
Unified RTSM vs traditional RTSM architecture
A unified RTSM architecture embeds randomization and investigational product management directly within the clinical research environment preserving blinding integrity, reducing allocation discrepancies, and ensuring continuous supply control across sites.
| Aspect | Traditional IRT Architecture | Unified oomnia RTSM software |
|---|---|---|
| System structure | Standalone IRT connected to EDC and supply tools | RTSM operates within a unified clinical research architecture |
| Allocation control | External randomization engine; limited cross-system visibility | Allocation logic governed inside one controlled environment |
| Blinding management | Unblinding processes handled across separate systems | Integrated blinding controls with role-based access |
| IMP inventory tracking | Fragmented depot and site inventory monitoring | Centralized real-time visibility across sites and depots |
| Resupply coordination | Manual forecasting and site communication | Automated resupply triggers within one system |
| Data synchronization | Requires integration to align subject and kit data | No cross-system synchronization required |
| Audit traceability | Multiple audit layers across platforms | One unified audit history for allocation and supply events |
| Data reporting structure | Reporting generated across disconnected platforms | Centralized reporting across allocation, inventory, and supply workflows |
| Operational risk | Increased risk of allocation discrepancies | Reduced operational risk through structural integration |
Who This Is For
Who oomnia RTSM software is for
oomnia RTSM is designed for:
Sponsors managing complex allocation strategies across global trials
CROs coordinating investigational product logistics at scale
Clinical teams requiring controlled blinding and emergency unblinding workflows
Organizations seeking to reduce operational risk in treatment assignment and supply management
The Platform
All clinical trial tools unified in one clinical trial platform
EDC software
Unified Electronic Data Capture system for compliant, real-time clinical data collection
CTMSCTMS software
Automated trial management solution designed to streamline study oversight
ETMFeTMF software
Digital workspace for storing, managing, and accessing trial master file documents
ECONSENTeConsent software
Electronic informed consent solution designed for seamless participant consent capture
EPROePRO software
Real-time electronic patient-reported outcomes solution for patient data entry
ECOAeCOA software
Capture patient-reported outcomes, clinician assessments, and study data in real time without paper workflows
ESOURCEeSource clinical trials
Electronic source system that captures original site data in real time, fully validated and without manual transcription
Get Started
Ready to gain full control over randomization and trial supply management?
Protect allocation integrity, maintain blinding, and manage investigational product logistics within one unified clinical architecture.
Talk to our teamFrequently asked questions
What is RTSM software in clinical trials?
RTSM (Randomization and Trial Supply Management) software automates the allocation of treatments to trial participants and manages investigational product supply across clinical sites. Wemedoo's oomnia RTSM software handles randomization directly within the eCRF, tracks drug inventory in real time, and prevents supply shortages.
How does oomnia RTSM work without separate integration?
oomnia RTSM is built directly into the unified clinical trial system, so randomization happens within the same eCRF used for data capture. There is no need for a separate IRT system or complex integrations — treatment allocation, drug supply tracking, and site inventory management all operate within one solution.
What randomization algorithms does oomnia RTSM support?
oomnia RTSM supports all common randomization algorithms including simple randomization, block randomization, stratified randomization, minimization, and dynamic allocation. It handles both blinded and open-label designs for any trial scenario.
How does oomnia RTSM manage drug supply?
oomnia RTSM provides real-time tracking of investigational product inventory across all clinical trial sites, automated alerts for low supply thresholds, drug supply initialization for new sites, and shipment tracking to prevent supply disruptions and ensure trial continuity.
Can oomnia RTSM handle complex trial designs?
Yes, oomnia RTSM supports complex trial designs including adaptive trials, crossover studies, dose-escalation protocols, and multi-arm trials. The system dynamically adjusts randomization based on real-time enrollment data and protocol-defined criteria.