Datatrak Interna Stock Price, News & Analysis

Datatrak International, Inc. (OTC:DTRK) is a software-as-a-service (SaaS) provider of enterprise cloud-based technologies for the life sciences industry. The company focuses on unified eClinical solutions and related services that are designed to improve cost and time efficiencies in the clinical trials industry. Datatrak’s technology supports clinical research from preclinical stages through Phase I to Phase IV drug and device studies in multiple languages throughout the world.

Datatrak operates in the Professional, Scientific, and Technical Services sector, within the industry category of Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology). Its stock trades on the OTC Markets under the symbol DTRK. According to company information, Datatrak is based in Austin, Texas, and is also located in Cleveland, Ohio, and College Station, Texas, with team members and data hosting infrastructure in key service regions that include the United States, Europe, and Japan.

Core platform and eClinical solutions

Datatrak built its multi-component eClinical solution on a single, unified platform known as the Datatrak Enterprise Cloud. This platform supports deployment through an ASP or Enterprise Transfer offering and is used to accelerate the reporting of clinical research data from sites to sponsors and ultimately to regulatory authorities. The unified design is intended to provide a complete portfolio of software products that work together more efficiently than loosely integrated technologies.

The company describes its offerings as a complete eClinical platform that can be full service for clients in the life sciences industry. Over time, Datatrak has expanded its technology concept to include services delivery via its Clinical and Consulting Services group, which supports customers with implementation and use of the platform.

Datatrak Enterprise Cloud and functional modules

Datatrak’s platform is centered around what it describes as the industry’s first electronic data capture (EDC) system, which has expanded into an all-in-one eClinical solution. According to company materials, the platform integrates a wide range of clinical trial data management functions, including:

• EDC (electronic data capture)
• RTSM (randomization and trial supply management)
• RBM (risk-based monitoring)
• eTMF (electronic trial master file)
• CTMS (clinical trial management system)
• ePRO (electronic patient-reported outcomes)
• eCOA (electronic clinical outcome assessments)
• eConsent
• Endpoint adjudication
• Imaging data
• Safety
• Inventory management
• Enterprise and global oversight functions such as automated alerts, workflows, documents, and timelines

Datatrak describes this configuration as a true eSource solution that seamlessly integrates all aspects of clinical trial data management. The platform is accessed through a central dashboard with a single login, enabling users to manage multiple functions and processes within the same environment.

Datatrak Direct and decentralized trials

The company has introduced Datatrak Direct, described as a mobile app for smartphones and tablets available in iOS and Android stores. Datatrak Direct is presented as an all-in-one app for ePRO, eCOA, and eConsent, supporting data collection from patients or sites at any time and from any location. Data entered through the app is stored in the Datatrak Enterprise Cloud, which the company states helps clients gain enhanced insight into data across sites for faster and more informed decisions.

Datatrak positions Datatrak Direct as a decentralized clinical trial product that supports decentralized and hybrid clinical trials, sometimes referred to as virtual trials. The company notes that this product is relevant to remote patient engagement and the shift in clinical trial administration toward models that collect clinical data from patients in a wider range of settings.

Fountayn-powered platform and services

Datatrak states that its platform is powered by Fountayn and its full complement of data management services from study start-up to study closeout. Fountayn provides a full-service team of clinical operations and data management professionals who can assist with trial design, project management, data management, custom coding, study plan documentation, validation and quality assurance, study support services, and help desk solutions. These services are described as being available throughout the study lifecycle, with personnel based in the United States, the European Union, and Japan.

Regulatory and quality framework

According to company disclosures, Datatrak’s cloud-based platform is used in clinical trials across multiple regions and complies with several regulatory and quality standards. The company states that its technology and processes are compliant with 21 CFR Part 11, GDPR, GCP, HIPAA, and CDISC requirements, and that its systems are fully validated by an experienced team of software quality engineers. Datatrak emphasizes that its platform has been trusted for over thirty years by clinical trial professionals and has been used in thousands of clinical trials in numerous countries and on multiple continents.

Business model and industry role

Datatrak describes itself as a SaaS provider of enterprise cloud-based technologies, indicating that its business model is based on providing access to software and related services through a subscription or service-based model rather than on-premise licensing. Its unified eClinical solutions and Clinical and Consulting Services group are aimed at helping sponsors, contract research organizations (CROs), and other life sciences stakeholders manage clinical trial data more efficiently.

The company reports that it has seen growth in the number of revenue-generating contracts and customers around its Enterprise Cloud eClinical Platform, and that it has reinvested earnings into expanding its product line, including Datatrak Direct and business intelligence capabilities. It also notes that it has entered into contracts with CRO partners, including a contract for Datatrak eSource that incorporates multiple platform modules such as EDC, RTSM, eTMF, CTMS, ePRO, eConsent, and enterprise management functions.

Geographic footprint

Datatrak states that its cloud-based platform is trusted in many countries and across multiple continents, with data hosting infrastructure and team members in key regions including the United States, Europe, and Japan. The company notes that its software supports studies in multiple languages and that it is involved in training customers and partners on the use of its Enterprise Cloud Platform for global clinical trials.

Risk and regulatory disclosures

In its public communications, Datatrak includes forward-looking statements that are subject to uncertainties and factors beyond the company’s control. It notes that operating performance, revenue, profits, and other outcomes can be affected by factors such as client spending, regulatory conditions, and broader economic and public health developments. The company highlights that backlog of contracted work may not be an accurate predictor of short-term revenue, as contracts can be delayed, canceled, or change in scope.

Frequently asked questions (FAQ)

The following FAQs summarize key aspects of Datatrak International, Inc. based on available information.

• What does Datatrak International, Inc. do?
  Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Its unified eClinical solutions and related services support clinical trials by helping accelerate the reporting of clinical research data from sites to sponsors and regulatory authorities.
• What is the Datatrak Enterprise Cloud?
  The Datatrak Enterprise Cloud is the company’s unified eClinical platform built on a single architecture. It supports preclinical and Phase I–IV drug and device studies in multiple languages and can be deployed through an ASP or Enterprise Transfer model. The platform integrates multiple clinical trial functions such as EDC, CTMS, eTMF, and other modules.
• What is Datatrak Direct?
  Datatrak Direct is a mobile app for iOS and Android that Datatrak describes as an all-in-one solution for ePRO, eCOA, and eConsent. It enables data collection from patients or sites at any time and from any location, with data stored in the Datatrak Enterprise Cloud to support decentralized and hybrid clinical trials.
• Which industry and sector does Datatrak operate in?
  Datatrak operates in the Professional, Scientific, and Technical Services sector. Its industry classification is Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology).
• Where is Datatrak based?
  Datatrak states that it is based in Austin, Texas, and that it is located in Cleveland, Ohio, and College Station, Texas. It also reports having team members and data hosting infrastructure in key service regions of the United States, Europe, and Japan.
• How does Datatrak support decentralized and hybrid clinical trials?
  Datatrak supports decentralized and hybrid clinical trials through its Enterprise Cloud platform and Datatrak Direct app. These tools enable virtual and remote data capture, including ePRO, eCOA, and eConsent, and integrate that data into a unified cloud environment for analysis and oversight.
• What regulatory and quality standards does Datatrak report compliance with?
  Datatrak reports that its platform and processes comply with 21 CFR Part 11, GDPR, GCP, HIPAA, and CDISC standards. The company states that its systems are fully validated by an experienced team of software quality engineers.
• Who uses Datatrak’s eClinical solutions?
  Company materials indicate that Datatrak’s solutions are used by clinical trial professionals, including sponsors and CROs, in the life sciences industry. The technology is deployed worldwide for drug and device studies across multiple phases.
• How long has Datatrak been involved in healthcare and life sciences technology?
  Datatrak states that clinical trial professionals have trusted its technology solutions for over thirty years and that it has been innovating in healthcare and life sciences for that period.
• What stock symbol does Datatrak trade under?
  Datatrak International, Inc. trades on the OTC Markets under the ticker symbol DTRK.