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RTSM/IWRS: Randomization and Trial Supply Management

Robust, reliable, and highly customizable to fit any study protocol. Natively integrated into EDC to operate all-in-one seamlessly. Fountayn can simplify all of the aspects of the randomization and trial supply management process online, allowing for a safer, faster, and more improved workflow for your study. Datatrak’s Randomization system is renowned for its reliability and stability in handling the most complex studies.

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Flexibility that Fits Your Needs to Control Compliance

With our configurable solution, Fountayn can address the most complicated trial randomization or adaptive trial design.

Instant Trial Supply Insights

Search, filter, and export supply figures or upcoming expiring supplies at sites in one central location.

Inventory Management

Automate and track shipping online to help optimize the trial’s timeline and stay on top of resupply.

Natively Integrated with EDC

A Robust Enterprise Platform for Drug and Treatment Supply

Datatrak’s Trial Supply Management system is a robust enterprise resource management platform for dispensing, controlling, and automating drug and treatment supply fulfillment. Our RTSM can be customized to all types of protocol randomizations to ensure balance, eliminate selection bias, and limit predictability — including double blinded, double masked, multi-phase randomizations, different cohorts, and more.

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Key Capabilities

Natively integrated with EDC — operates all-in-one seamlessly
Supports double blinded, double masked, and multi-phase randomizations
Eliminates selection bias and limits predictability
Dispense, control, and automate drug and treatment supply fulfillment
Search, filter, and export real-time supply figures from one location

Integrated Solutions

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Electronic Data Capture (EDC)

A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.

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Clinical Trial Management (CTMS)

Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.

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Electronic Trial Master File (eTMF)

Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.

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eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

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Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with a cloud-based pharmacovigilance software platform built for compliance.

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EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

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Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

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Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

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"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user friendly, and site staff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

Frequently Asked Questions

What is RTSM in clinical trials?

RTSM stands for Randomization and Trial Supply Management. It is the technology that assigns participants to study arms and manages the dispensing, tracking, and resupply of the drugs or treatments used in a trial. Datatrak’s RTSM is natively integrated into EDC to operate all-in-one seamlessly, and is renowned for its reliability and stability in handling the most complex studies.

What is the difference between RTSM and IWRS?

RTSM (Randomization and Trial Supply Management) and IWRS (Interactive Web Response System) describe essentially the same capability. IWRS is the older term for the web-based interface used to randomize participants and request supply, while RTSM is the broader industry term that covers both randomization and the full supply management workflow. Datatrak’s platform delivers both, configurable to any study protocol.

What types of randomizations does Datatrak’s RTSM software support?

Our configurable solution can address the most complicated trial randomization or adaptive trial design, including double blinded, double masked, multi-phase randomizations, different cohorts, and more. Datatrak’s RTSM is built to ensure balance, eliminate selection bias, and limit predictability, while giving you a central place to search, filter, and export real-time supply figures at sites.