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Clinical Trial Management System (CTMS)

Natively integrated with Datatrak EDC, RTSM, and eTMF.

Datatrak's CTMS software optimizes your workflow with real-time insight-driven data and analytics, empowering users to accelerate the progress of clinical trials. View and control all clinical operation information and workflows for your study in one seamless and configurable platform.

Acting as a repository for clinical operations, our CTMS includes functions for site feasibility and the tracking of action items and milestones. Throughout our platform, we deliver your clinical trial data across our products proactively in real-time, ensuring your team has the most up-to-date information to accelerate progress.

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Simplify Regulatory Submissions

Track and store relevant documents in a controlled environment and easily create checklists to manage your regulatory submission requirements.

Increase Monitor Productivity

Streamline the creation of monitoring reports by configuring a collection of templates that are easily duplicated and tailored by you.

Optimize Workflow

With intuitive dashboards and robust reporting capabilities, you can verify data across all studies in a single location.

Natively Integrated

Natively Integrated with EDC, RTSM, and eTMF

Acting as a repository for clinical operations, our clinical trial management system includes functions for site feasibility and the tracking of action items and milestones. Throughout our platform, we deliver your clinical trial data across our products proactively in real-time, ensuring your team has the most up-to-date information to accelerate progress.

See How It Works

Key Capabilities

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    Site feasibility and milestone tracking

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    Real-time data delivered proactively across products

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    Intuitive dashboards to verify data across all studies

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    Interface-driven configuration — no technical skills required

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.

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.

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.

eConsent

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

Post Market Surveillance

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

EMR/EHR

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

Trial Design

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

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 a CTMS in clinical trials?

A clinical trial management system, or CTMS, is the central hub for managing the operational side of a study, including site feasibility, monitoring visits, milestones, action items, and regulatory submissions. Datatrak’s CTMS gives study teams real-time insight-driven data and analytics in one seamless and configurable platform, so you can view and control all clinical operation information and workflows for your study in a single place.

What is the difference between a CTMS and an eTMF?

A CTMS manages the operational workflows of a trial, including site feasibility, milestones, monitoring reports, and regulatory submission tracking, while an eTMF is a compliant document repository for the trial master file itself. Datatrak offers both products natively integrated alongside our EDC and RTSM, so operational data and supporting documents stay connected throughout the study without duplicate data entry.

How does Datatrak’s CTMS software increase monitor productivity?

Monitors spend a significant portion of their time building and updating reports. Our CTMS streamlines the creation of monitoring reports by configuring a collection of templates that are easily duplicated and tailored by you. Paired with intuitive dashboards and robust reporting, you can verify data across all studies in a single location and keep teams focused on insight instead of administration.

News & Insights

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