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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 acloud-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 terapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intiutive 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. They system is easy to use, you can create customized forms, manage study participants, securly 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 frienidly, and site stasff 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

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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Increase Diversity in Clinical Trials

Discussions around improving diversity in clinical trials have been ongoing for quite some time, with relatively gradual change to actual practice.

Finally Fountayn

In early 2022, we made the concrete decision to transition away from the Datatrak name and brand and rebrand to a fresh and modern look.

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Ensuring Data Quality with Fountayn

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Passing the Stress Test: Clinical Trials Day 2023

In honor of Clinical Trials, day we’d like to take a moment to reflect on not only one of the most outstanding moments in the history of clinical trials, but in the broader field of science.

Today's Clinical Trials Need More Than Just an EDC

As the Clinical Trial process has continued to improve over the last several years, the benefits of using an EDC system has become widely known throughout the industry.

Technology for Decentralized Trials: Agility Allows You to Pivot

This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization.

Technology for Decentralized Trials: Providing Control and the Freedom to Innovate

This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization.

Study Design in Fountayn: Build your Own Adventure

The Fountayn Solution Services department within Fountayn was established in 2010 and has operated on the key premise of offering customizable solutions that best fit the needs of each of our clients.

Future Forward with Scalable Software

Scalability in a software offering is a system’s ability to adjust its capacity and functionalities based on its users’ demand.

Fountayn CTMS expanded with Business Intelligence

Clinical trials contain hundreds of millions of data points that can be used to help identify trial issues or trends.

Five Best Practices for Building a Robust EDC System

Electronic data capture (EDC) systems are essential and ubiquitous tools used in the Life Sciences industry by academic, medical device, biotech and pharmaceutical companies.

EDC Design With the End User in Mind

User experience is important within any software as it focuses on ensuring the product is doing its job correctly and in the most helpful way.

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When evaluating a vendor, especially a technology vendor, certain items are expected like security and compliance. One of the ways to ensure a vendor is secure and compliant is being SOC 2® Type II certified.

Customer Experience Questions to Ask Your eClinical Vendor

When choosing an eClinical vendor, it is important to understand the customer service/experience they will provide.

Clinical Trial Site Communications – A Must Have

In today’s world, this mantra means a lot more than it used to. Keeping lines of communication open is the path to staying afloat in difficult times. Clinical trial sites are no exception. The question is how do all of your research sites stay connected, especially these days.

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The Importance of Mid-Study Changes

What are mid-study changes and why are they so important to the lifecycle of a clinical trial?

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eClinical technologies have become pervasive across clinical trials, whether the study is more traditional or implements decentralized elements.

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Fountayn strives to be a valuable partner to our customers by providing the highest level of service as well as the most innovative technology. Our client’s satisfaction and success will always be our main priority.

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Adoption of risk-based monitoring practices has grown in the industry of clinical trials at a slow but steady pace over the last decade. For many looking to make this transition, however, the question of where to begin poses a challenging question.

Regulatory Support for eSource

eSource, broadly, is the idea that data entered into an electronic platform, like an EDC or an EHR, can be considered the source data for the purposes of reconstructing and evaluating the safety and efficacy of a clinical trial.

Why eSource: The Advantages of Abandoning Paper Records

The justification for designing eSource trials is in the advantages they provide in reliability across most human tasks that interface with a clinical trial database. In short, eSource as a strategy eliminates a broad spectrum of potential transcription errors in addition to fully leveraging the supporting eClinical technology to provide reliable consistent exchange of information.

The Challenges with eSource

Our previous post illustrated some of the most significant benefits to operational effectiveness and efficiency in clinical trials by implementing eSource practices. These advantages speak for themselves.

Industry Trend: Patient-Centered Medicine

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All About the Acronyms

The clinical trials industry is known for it’s extensive use of acronyms, which can often be confusing for those not familiar with the field. With numerous regulatory bodies, organizations, and medical terms, it’s no wonder that the industry has a vast array of acronyms. These are used to describe everything from medical conditions to regulatory documents to save time and simplify communication.

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Patient wearing EEG cap during clinical study