ClinRT

iClinRT

Configuration That Matters

Your Trial's Operational Control Center.

What is iClinRT

Configuration That Matters

Your Trial's Operational Control Center.

iClinRT is ClinRT's dynamic, fully configurable Interactive Response Technology platform designed to streamline and safeguard clinical trial execution across the globe. It serves as the central coordination engine that connects subject workflows, treatment allocation logic, supply movement, site actions, and real-time insights ensuring your trial runs exactly as designed.

It understands your protocol, adapts to study complexity, and ensures each operational step is executed with precision, visibility, and compliance.

See it in action - request a demo

Protocol Logic

Treatment Flow

Supply Engine

Live Insights

Services iClinRT Delivers

Operational depth for every subject and kit movement

Service 01iClinRT

Subject Management

Supports screening, enrollment, and subject status updates in real time.
Guides sites through protocol-aligned visit workflows (scheduled or unscheduled).
Applies guardrails to reduce deviations and data entry errors.
Provides clear subject timelines (visit due, completed, missed, rescheduled).
Maintains an audit trail for all subject actions.

Service 02iClinRT

Subject Randomization and Treatment Assignment

Executes unbiased, protocol-aligned allocation across arms, cohorts, and strata.
Preserves blinding integrity and supports emergency unblinding with full logs.
Handles complex designs (block, stratified, cohort expansion) without delays.
Links treatment assignment to visit dosing for operational consistency.
Captures allocation decisions with time and user stamps for inspection readiness.

Service 03iClinRT

Kit Management and Assignment

Tracks kit creation, status, and location (depot to site to subject).
Matches the right kit to the right subject and visit per protocol.
Uses barcode verification to prevent dispensing errors.
Supports returns, quarantines, replacements, and status changes.
Maintains full traceability for accountability and audits.

Service 04iClinRT

Triggers and Auto Shipments

Predicts site-level demand using enrollment, dosing cadence, and historical use.
Auto-generates resupply shipments based on predefined buffer rules and thresholds.
Minimizes stock-outs and urgent shipments through proactive planning.
Adjusts to changes in recruitment or dosing with dynamic trigger logic.
Provides shipment visibility (created, dispatched, received, reconciled).

Service 05iClinRT

Kit Expiry Date Management

Monitors expiry per kit or lot and flags early warning windows.
Supports safe dispense rules (do not assign within X days of expiry).
Guides redistribution and replacement to reduce wastage.
Captures expiry-related actions (quarantine, destroy) with documentation.
Surfaces site-level views of usable vs near-expiry inventory.

Service 06iClinRT

Drug and Supply Management

Provides end-to-end IMP oversight from packaging to final disposition.
Maintains chain-of-custody across depots, couriers, sites, and subjects.
Supports temperature mapping for cold-chain products and records excursion reviews.
Manages retention samples with custody and location tracking.
Offers planning and reconciliation views for supply teams (by region, site, lot).

Service 07iClinRT

Site-Level Inventory Management

Shows real-time on-hand inventory by kit, lot, and status at each site.
Highlights reserved, quarantined, and near-expiry stock for quick action.
Enables site-to-site transfers with traceable approvals and receipts.
Reduces manual logs with automatic updates from dispensing and returns.
Aligns inventory readiness with upcoming visit schedules.

Global Compliance

Built to meet global regulatory and data-integrity requirements

ICHICH GCP

FDAFDA 21 CFR Part 11

GAMPGAMP 5

GXPGXP

HIPAAHIPAA

GDPRGDPR

CDSCOCDSCO

MEDMedRA

CDISCCDISC

EUEU Annex 11

ICHICH GCP

FDAFDA 21 CFR Part 11

GAMPGAMP 5

GXPGXP

HIPAAHIPAA

GDPRGDPR

CDSCOCDSCO

MEDMedRA

CDISCCDISC

EUEU Annex 11

iClinRT's Potential

Features that unlock clarity, control, and speed

Potential 01iClinRT

Management of every Subject

Supports screening, enrollment, and visit flow.
Ensures sites follow protocol-aligned steps.
Keeps subject status clear and organized.

Potential 02iClinRT

Fair Treatment Assignments

Assigns subjects to arms without bias.
Handles cohorts, stratification, and multi-arm setups.
Protects allocation integrity.

Potential 03iClinRT

Supply That Thinks Ahead

Tracks inventory at depots and sites.
Predicts supply needs and auto-triggers shipments.
Helps prevent shortages and reduce wastage.

Potential 04iClinRT

Smart Kit Assignment

Ensures the correct physical kit is given to the right participant.
Checks kit status (available, reserved, expired, returned).
Uses barcode scanning for quick, error-free verification.
Matches kits to visit schedules in real time.
Minimizes dispensing mistakes at sites.

Potential 05iClinRT

Safety First - Expiry Under Control

Monitors expiry dates continuously.
Alerts teams before a kit expires.
Ensures expired kits are never used.

Potential 06iClinRT

Kit Lifecycle Tracking

Tracks each kit from creation to destruction.
Logs dispensing, returns, and reconciliation.
Maintains inspection-ready records.

Potential 07iClinRT

Barcode-Enabled Tracking

Supports barcode scanning at sites and depots.
Reduces manual errors in kit selection and handling.
Speeds up dispensing, returns, and accountability workflows.

Potential 08iClinRT

Controlled Unblinding - For True Emergencies Only

Secure unblinding for medical emergencies.
Logs every action for audit trails.
Protects trial integrity.

Potential 09iClinRT

Reports and Dashboards for Complete Visibility

Real-time view of enrollment, supply, and visits.
Role-based filters for sponsors, CROs, sites, and depots.
Supports faster, more confident decisions.

Potential 10iClinRT

Stay Ahead with Notifications and Alerts

Alerts for supply risk, expiries, shipments, or key events.
Helps teams act early and avoid delays.
Keeps stakeholders aligned.

Potential 11iClinRT

24x7 Expert Assisted Support

Dedicated helpdesk for sites and study teams.
Technical and workflow assistance.
Ensures smooth daily operations.

Potential 12iClinRT

Quick Site-to-Site Transfers

Enables safe, traceable transfers of study drug kits between sites.
Helps manage fast enrollment or local shortages.
Maintains complete visibility during movement.

Potential 13iClinRT

Cold-Chain and Excursion Handling

Tracks temperature-sensitive kits.
Flags excursions for review.
Supports usability decisions and compliance.

Potential 14iClinRT

Retention Sample Management

Manages long-term storage samples.
Tracks movement and location.
Supports regulatory and scientific needs.

Potential 15iClinRT

Study Startup and Go-Live Setup

Configuration, testing, validation, and training.
Ensures readiness before first-patient-in.
Smooth transition into conduct.

View factsheets

How It Works

A four-layer engine driving trial efficiency

A visual workflow of protocol intelligence, orchestration, supply control, and compliant insight.

Layer 1Engine

Protocol Intelligence

Encode study logic, eligibility, and treatment rules into a single source of truth.

Layer 2Engine

Workflow Orchestration

Coordinate subject visits, randomization, and site actions with protocol-aligned guardrails.

Layer 3Engine

Supply and Inventory Engine

Automate kit movement, expiry management, and resupply triggers across depots and sites.

Layer 4Engine

Insights and Compliance

Deliver real-time dashboards, audit trails, and inspection-ready documentation.

Protocol Sync

Live Oversight

Study Types We Support

Built for complex programs across phases and regions

OncologyRare DiseasesBiologicsVaccine TrialsMedical Device TrialsEarly to Late Phase StudiesMany More Complex Trials

iClinRT supports early to late phase studies, adaptive designs, and global programs that require precision supply, protocol control, and inspection-ready documentation.

iClinRT's USPs

Purpose-built for complexity. Designed for speed. Trusted for reliability.

USP 01iClinRT

Fast 4-Week Setup

Rapid configuration and validation to support First Patient In timelines.
Handles multi-arm, cohort-based, and stratified designs without delay.
Streamlined user acceptance testing and protocol-aligned setup.

USP 02iClinRT

Deep Industry Expertise

Led by teams experienced in IRT and clinical trial supply management.
Strong understanding of real clinical workflows across phases and therapeutic areas.
Practical guidance that supports sites, CROs, and Sponsors.

USP 03iClinRT

Smarter Supply Management

Predicts supply requirements based on enrollment trends and dosing schedules.
Ensures stable IMP inventory across depots and sites.
Supports site-to-site kit transfers, retention sample management, and cold-chain needs.

USP 04iClinRT

Compliance Built-In

Aligned with ICH-GCP, 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA.
Features complete audit trails, electronic signatures, and validated workflows.
Ensures records meet ALCOA+ principles for data integrity.

USP 05iClinRT

Seamless System Integrations

Connects with CTMS and EDC platforms.
Reduces manual reconciliation and improves data consistency.
Supports unified oversight similar to leading integrated platforms.

USP 06iClinRT

Designed for Users

Clear, real-time dashboards for enrollment, visits, supply, and site performance.
Simple, protocol-aligned workflows minimize site burden.
Supported by a responsive helpdesk for operational and technical queries.

USP 07iClinRT

Flexible, Scalable, User-Friendly

Adapts to early-phase, late-phase, and global multi-region studies.
Easily accommodates mid-study protocol amendments.
Remains intuitive and reliable as study scope grows.

Problem to Solution

Solve operational bottlenecks with iClinRT

Each real-world problem is matched to a concrete operational solution, rolling continuously for quick scanning.

Talk to the ClinRT team Ask for a workflow review

Problem

Imbalanced treatment arms in complex designs

Protocol-aligned randomization across arms, cohorts, and strata.

Problem

Site stock-outs or over-stock

Predictive resupply and automated depot-to-site shipments.

Problem

Dispensing errors at the site

Barcode-verified kit assignment at the right visit.

Problem

Poor visibility of kit status and movement

End-to-end kit traceability from creation to dispense, return, reconcile, and destroy.

Problem

Cold-chain uncertainty during storage or transport

Temperature mapping to record, review, and document integrity.

Problem

Kits nearing expiry and late action

Expiry tracking with early alerts and replacement guidance.

Problem

Retention samples missed or mishandled

Retention sample tracking with clear custody and status.

Problem

Inconsistent visit execution across sites

Protocol-driven subject and visit workflows.

Problem

Limited real-time oversight for sponsors and CROs

Live dashboards, configurable reports, and event-based alerts.

Problem

Operational disruption after protocol amendments

Amendment-friendly configuration that updates logic without derailing sites.

Problem

Audit and inspection readiness concerns

Audit trails, role-based access, e-signatures, and ALCOA+ records.

Problem

Multi-country coordination challenges

Unified oversight across regions, depots, and sites in one system.

Problem

Slow issue resolution at sites

Responsive helpdesk and study support for operational queries.

Problem

Data duplication across systems

Seamless integrations with CTMS, EDC, and other eClinical platforms.

Problem

Imbalanced treatment arms in complex designs

Protocol-aligned randomization across arms, cohorts, and strata.

Problem

Site stock-outs or over-stock

Predictive resupply and automated depot-to-site shipments.

Problem

Dispensing errors at the site

Barcode-verified kit assignment at the right visit.

Problem

Poor visibility of kit status and movement

End-to-end kit traceability from creation to dispense, return, reconcile, and destroy.

Problem

Cold-chain uncertainty during storage or transport

Temperature mapping to record, review, and document integrity.

Problem

Kits nearing expiry and late action

Expiry tracking with early alerts and replacement guidance.

Problem

Retention samples missed or mishandled

Retention sample tracking with clear custody and status.

Problem

Inconsistent visit execution across sites

Protocol-driven subject and visit workflows.

Problem

Limited real-time oversight for sponsors and CROs

Live dashboards, configurable reports, and event-based alerts.

Problem

Operational disruption after protocol amendments

Amendment-friendly configuration that updates logic without derailing sites.

Problem

Audit and inspection readiness concerns

Audit trails, role-based access, e-signatures, and ALCOA+ records.

Problem

Multi-country coordination challenges

Unified oversight across regions, depots, and sites in one system.

Problem

Slow issue resolution at sites

Responsive helpdesk and study support for operational queries.

Problem

Data duplication across systems

Seamless integrations with CTMS, EDC, and other eClinical platforms.

Ready to See iClinRT

Bring operational clarity to every trial milestone

Connect your teams, sites, and supply workflows with a platform designed for protocol fidelity, compliance, and real-time insight.

Request iClinRT Demo Ask a workflow expert

Live Q&A

Question

How fast can we go live with iClinRT?

Answer

Most programs are configured and validated in about four weeks.

iClinRT

Configuration That Matters

Your Trial's Operational Control Center.

See it in action - request a demo

What is iClinRT

Configuration That Matters

Your Trial's Operational Control Center.

It understands your protocol, adapts to study complexity, and ensures each operational step is executed with precision, visibility, and compliance.

See it in action - request a demo

Protocol Logic

Treatment Flow

Supply Engine

Live Insights

Services iClinRT Delivers

Operational depth for every subject and kit movement

Service 01iClinRT

Subject Management

Supports screening, enrollment, and subject status updates in real time.
Guides sites through protocol-aligned visit workflows (scheduled or unscheduled).
Applies guardrails to reduce deviations and data entry errors.
Provides clear subject timelines (visit due, completed, missed, rescheduled).
Maintains an audit trail for all subject actions.

Service 02iClinRT

Subject Randomization and Treatment Assignment

Executes unbiased, protocol-aligned allocation across arms, cohorts, and strata.
Preserves blinding integrity and supports emergency unblinding with full logs.
Handles complex designs (block, stratified, cohort expansion) without delays.
Links treatment assignment to visit dosing for operational consistency.
Captures allocation decisions with time and user stamps for inspection readiness.

Service 03iClinRT

Kit Management and Assignment

Tracks kit creation, status, and location (depot to site to subject).
Matches the right kit to the right subject and visit per protocol.
Uses barcode verification to prevent dispensing errors.
Supports returns, quarantines, replacements, and status changes.
Maintains full traceability for accountability and audits.

Service 04iClinRT

Triggers and Auto Shipments

Predicts site-level demand using enrollment, dosing cadence, and historical use.
Auto-generates resupply shipments based on predefined buffer rules and thresholds.
Minimizes stock-outs and urgent shipments through proactive planning.
Adjusts to changes in recruitment or dosing with dynamic trigger logic.
Provides shipment visibility (created, dispatched, received, reconciled).

Service 05iClinRT

Kit Expiry Date Management

Monitors expiry per kit or lot and flags early warning windows.
Supports safe dispense rules (do not assign within X days of expiry).
Guides redistribution and replacement to reduce wastage.
Captures expiry-related actions (quarantine, destroy) with documentation.
Surfaces site-level views of usable vs near-expiry inventory.

Service 06iClinRT

Drug and Supply Management

Provides end-to-end IMP oversight from packaging to final disposition.
Maintains chain-of-custody across depots, couriers, sites, and subjects.
Supports temperature mapping for cold-chain products and records excursion reviews.
Manages retention samples with custody and location tracking.
Offers planning and reconciliation views for supply teams (by region, site, lot).

Service 07iClinRT

Site-Level Inventory Management

Shows real-time on-hand inventory by kit, lot, and status at each site.
Highlights reserved, quarantined, and near-expiry stock for quick action.
Enables site-to-site transfers with traceable approvals and receipts.
Reduces manual logs with automatic updates from dispensing and returns.
Aligns inventory readiness with upcoming visit schedules.

Global Compliance

Built to meet global regulatory and data-integrity requirements

ICHICH GCP

FDAFDA 21 CFR Part 11

GAMPGAMP 5

GXPGXP

HIPAAHIPAA

GDPRGDPR

CDSCOCDSCO

MEDMedRA

CDISCCDISC

EUEU Annex 11

ICHICH GCP

FDAFDA 21 CFR Part 11

GAMPGAMP 5

GXPGXP

HIPAAHIPAA

GDPRGDPR

CDSCOCDSCO

MEDMedRA

CDISCCDISC

EUEU Annex 11

iClinRT's Potential

Features that unlock clarity, control, and speed

Potential 01iClinRT

Management of every Subject

Supports screening, enrollment, and visit flow.
Ensures sites follow protocol-aligned steps.
Keeps subject status clear and organized.

Potential 02iClinRT

Fair Treatment Assignments

Assigns subjects to arms without bias.
Handles cohorts, stratification, and multi-arm setups.
Protects allocation integrity.

Potential 03iClinRT

Supply That Thinks Ahead

Tracks inventory at depots and sites.
Predicts supply needs and auto-triggers shipments.
Helps prevent shortages and reduce wastage.

Potential 04iClinRT

Smart Kit Assignment

Ensures the correct physical kit is given to the right participant.
Checks kit status (available, reserved, expired, returned).
Uses barcode scanning for quick, error-free verification.
Matches kits to visit schedules in real time.
Minimizes dispensing mistakes at sites.

Potential 05iClinRT

Safety First - Expiry Under Control

Monitors expiry dates continuously.
Alerts teams before a kit expires.
Ensures expired kits are never used.

Potential 06iClinRT

Kit Lifecycle Tracking

Tracks each kit from creation to destruction.
Logs dispensing, returns, and reconciliation.
Maintains inspection-ready records.

Potential 07iClinRT

Barcode-Enabled Tracking

Supports barcode scanning at sites and depots.
Reduces manual errors in kit selection and handling.
Speeds up dispensing, returns, and accountability workflows.

Potential 08iClinRT

Controlled Unblinding - For True Emergencies Only

Secure unblinding for medical emergencies.
Logs every action for audit trails.
Protects trial integrity.

Potential 09iClinRT

Reports and Dashboards for Complete Visibility

Real-time view of enrollment, supply, and visits.
Role-based filters for sponsors, CROs, sites, and depots.
Supports faster, more confident decisions.

Potential 10iClinRT

Stay Ahead with Notifications and Alerts

Alerts for supply risk, expiries, shipments, or key events.
Helps teams act early and avoid delays.
Keeps stakeholders aligned.

Potential 11iClinRT

24x7 Expert Assisted Support

Dedicated helpdesk for sites and study teams.
Technical and workflow assistance.
Ensures smooth daily operations.

Potential 12iClinRT

Quick Site-to-Site Transfers

Enables safe, traceable transfers of study drug kits between sites.
Helps manage fast enrollment or local shortages.
Maintains complete visibility during movement.

Potential 13iClinRT

Cold-Chain and Excursion Handling

Tracks temperature-sensitive kits.
Flags excursions for review.
Supports usability decisions and compliance.

Potential 14iClinRT

Retention Sample Management

Manages long-term storage samples.
Tracks movement and location.
Supports regulatory and scientific needs.

Potential 15iClinRT

Study Startup and Go-Live Setup

Configuration, testing, validation, and training.
Ensures readiness before first-patient-in.
Smooth transition into conduct.

View factsheets

How It Works

A four-layer engine driving trial efficiency

A visual workflow of protocol intelligence, orchestration, supply control, and compliant insight.

Layer 1Engine

Protocol Intelligence

Encode study logic, eligibility, and treatment rules into a single source of truth.

Layer 2Engine

Workflow Orchestration

Coordinate subject visits, randomization, and site actions with protocol-aligned guardrails.

Layer 3Engine

Supply and Inventory Engine

Automate kit movement, expiry management, and resupply triggers across depots and sites.

Layer 4Engine

Insights and Compliance

Deliver real-time dashboards, audit trails, and inspection-ready documentation.

Protocol Sync

Live Oversight

Study Types We Support

Built for complex programs across phases and regions

OncologyRare DiseasesBiologicsVaccine TrialsMedical Device TrialsEarly to Late Phase StudiesMany More Complex Trials

iClinRT supports early to late phase studies, adaptive designs, and global programs that require precision supply, protocol control, and inspection-ready documentation.

iClinRT's USPs

Purpose-built for complexity. Designed for speed. Trusted for reliability.

USP 01iClinRT

Fast 4-Week Setup

Rapid configuration and validation to support First Patient In timelines.
Handles multi-arm, cohort-based, and stratified designs without delay.
Streamlined user acceptance testing and protocol-aligned setup.

USP 02iClinRT

Deep Industry Expertise

Led by teams experienced in IRT and clinical trial supply management.
Strong understanding of real clinical workflows across phases and therapeutic areas.
Practical guidance that supports sites, CROs, and Sponsors.

USP 03iClinRT

Smarter Supply Management

Predicts supply requirements based on enrollment trends and dosing schedules.
Ensures stable IMP inventory across depots and sites.
Supports site-to-site kit transfers, retention sample management, and cold-chain needs.

USP 04iClinRT

Compliance Built-In

Aligned with ICH-GCP, 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA.
Features complete audit trails, electronic signatures, and validated workflows.
Ensures records meet ALCOA+ principles for data integrity.

USP 05iClinRT

Seamless System Integrations

Connects with CTMS and EDC platforms.
Reduces manual reconciliation and improves data consistency.
Supports unified oversight similar to leading integrated platforms.

USP 06iClinRT

Designed for Users

Clear, real-time dashboards for enrollment, visits, supply, and site performance.
Simple, protocol-aligned workflows minimize site burden.
Supported by a responsive helpdesk for operational and technical queries.

USP 07iClinRT

Flexible, Scalable, User-Friendly

Adapts to early-phase, late-phase, and global multi-region studies.
Easily accommodates mid-study protocol amendments.
Remains intuitive and reliable as study scope grows.

Problem to Solution

Solve operational bottlenecks with iClinRT

Each real-world problem is matched to a concrete operational solution, rolling continuously for quick scanning.

Talk to the ClinRT team Ask for a workflow review

Problem

Imbalanced treatment arms in complex designs

Protocol-aligned randomization across arms, cohorts, and strata.

Problem

Site stock-outs or over-stock

Predictive resupply and automated depot-to-site shipments.

Problem

Dispensing errors at the site

Barcode-verified kit assignment at the right visit.

Problem

Poor visibility of kit status and movement

End-to-end kit traceability from creation to dispense, return, reconcile, and destroy.

Problem

Cold-chain uncertainty during storage or transport

Temperature mapping to record, review, and document integrity.

Problem

Kits nearing expiry and late action

Expiry tracking with early alerts and replacement guidance.

Problem

Retention samples missed or mishandled

Retention sample tracking with clear custody and status.

Problem

Inconsistent visit execution across sites

Protocol-driven subject and visit workflows.

Problem

Limited real-time oversight for sponsors and CROs

Live dashboards, configurable reports, and event-based alerts.

Problem

Operational disruption after protocol amendments

Amendment-friendly configuration that updates logic without derailing sites.

Problem

Audit and inspection readiness concerns

Audit trails, role-based access, e-signatures, and ALCOA+ records.

Problem

Multi-country coordination challenges

Unified oversight across regions, depots, and sites in one system.

Problem

Slow issue resolution at sites

Responsive helpdesk and study support for operational queries.

Problem

Data duplication across systems

Seamless integrations with CTMS, EDC, and other eClinical platforms.

Problem

Imbalanced treatment arms in complex designs

Protocol-aligned randomization across arms, cohorts, and strata.

Problem

Site stock-outs or over-stock

Predictive resupply and automated depot-to-site shipments.

Problem

Dispensing errors at the site

Barcode-verified kit assignment at the right visit.

Problem

Poor visibility of kit status and movement

End-to-end kit traceability from creation to dispense, return, reconcile, and destroy.

Problem

Cold-chain uncertainty during storage or transport

Temperature mapping to record, review, and document integrity.

Problem

Kits nearing expiry and late action

Expiry tracking with early alerts and replacement guidance.

Problem

Retention samples missed or mishandled

Retention sample tracking with clear custody and status.

Problem

Inconsistent visit execution across sites

Protocol-driven subject and visit workflows.

Problem

Limited real-time oversight for sponsors and CROs

Live dashboards, configurable reports, and event-based alerts.

Problem

Operational disruption after protocol amendments

Amendment-friendly configuration that updates logic without derailing sites.

Problem

Audit and inspection readiness concerns

Audit trails, role-based access, e-signatures, and ALCOA+ records.

Problem

Multi-country coordination challenges

Unified oversight across regions, depots, and sites in one system.

Problem

Slow issue resolution at sites

Responsive helpdesk and study support for operational queries.

Problem

Data duplication across systems

Seamless integrations with CTMS, EDC, and other eClinical platforms.

Ready to See iClinRT

Bring operational clarity to every trial milestone

Connect your teams, sites, and supply workflows with a platform designed for protocol fidelity, compliance, and real-time insight.

Request iClinRT Demo Ask a workflow expert

Live Q&A

Question

How fast can we go live with iClinRT?

Answer

Most programs are configured and validated in about four weeks.