TrialStat® launches eClinical Suite™

TrialStat®, a division of Jubilant Clinsys Inc., announces the release of Trialstat eClinical Suite. TrialStat eClinical Suite is a cloud based system that uses the latest in today’s technology to revolutionize and redefine integrated clinical software. TrialStat enables you to use one system for all clinical phases including, from build your own EDC for Phase 1; to advanced EDC, CTMS, and Portal functionality for Phase 2 and 3; to flexible electronic patient access for Late Phase. Utilizing data entered in one system to trigger functionality in another we improve study compliance, simplify usability, and provide insight into your clinical research. TrialStat eClinical Suite is a fully scalable solution that deploys trials in 2 – 4 weeks, recognizes efficiencies, and provides one system that enables you to visualize and enhance your clinical development lifecycle.

Fast. Optimized. Innovative.

TrialStat eClinical Suiteis enabling organizations to accelerate their time-to-market and improve the overall quality of their clinical research through a modular suite of innovative and easy-to-use on demand features. From emerging bio-technology, mid-sized CROs to large pharmaceutical companies, ORBIT provides a robust, scalable and configurable browser interface for any phase or therapeutic area, domestic or international study. All that's needed is a browser interface.

TrialStat Orbit™
Features at a Glance

Enhance your collection, management, cleaning and auditability of clinical data with our fully validated 21 CFR Part 11 compliant in-house EDC solution.

  • Footprint-free platform
  • Internet accessible
  • Rapid setup – typically 2x industry norms
  • Image based data capture
  • Subject log-in module enables e-diary data
  • User-friendly web browser interface
  • Eliminates need for handheld devices
  • Deploys globally
  • Real-time and post-data validation
  • Multiple languages configurable by project


Case Studies

Read our Case Studies to learn more about how TrialStat Orbit has changed the way our clients conduct their trials.

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Quick Links

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TrialStat Orbit Advantages: Read what sets us apart from other EDC systems.

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CROFirst: Putting our Partners First Program
Read about how our program is designed specifically to enable CROs to quickly deploy our on-demand EDC platform Orbit™ enhancing our clients' marketing and sales activities.

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TrialStat® (a technology arm of Jubilant Clinsys) is a leading provider of on demand EDC solutions which empower clinical research professionals to collect and manage clinical data nearly twice as fast as the industry average using innovative, easy to use configurable and flexible features through a secure browser interface released TrialStat Orbit v 5 the latest offering from the TrialStat eClinical Suite of products. TrialStat® has been successfully deployed at global locations in over 300 studies in a variety of therapeutic areas.

The latest version of TrialStat-ORBIT offers two main new features:

  • An enhanced data validation tool that provides real-time and post data validation
  • Subject Login Portal enabling 100% data collection accuracy with subject reported data

The new enhanced data validation tool enables TrialStat®'s global development team to produce an array of validation scenarios not previously available. The new version reduces timelines by performing real-time data cleaning, automatic triggering of Data Clarification Forms (DCFs), and automated e-mail alerts to users notifying them of a DCF action required, without users having to login to the application.

The new Subject Login Portal ensures robust capture of information input directly by study subjects which helps enrollment, retention and improves the quality of reported data for Phase IV studies. The dynamic data cleaning functionality ensures cleaner subject reported information. Additionally, the Subject Portal offers multiple languages configurable by project, customized login portal link, an easy-to-use interface, custom windows for data collection accuracy, form logic capabilities, full reporting and exporting of data.

Suite Components

  • EDC Component of the eClinical Suite
    EDC Component of the TrialStat eClinical Suite TrialStat-ORBIT™ v 5, the EDC component of the TrialStat eClinical Suite has been released. (+)
  • Portal Component of the eClinical Suite
    Portal Component of the TrialStat eClinical SuiteTrialStat Portal; is the Portal module of the TrialStat eClinical Suite.  (+)
  • CTMS Component of the eClinical Suite
    CTMS Component of the TrialStat eClinical SuiteTrialStat CTMS; is the CTMS module of the TrialStat eClinical Suite. (+)

Testimonials

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Clinical Development

"We have contracted with TrialStat® to handle the Electronic Data Capture, and Jubilant Clinsys to handle the data management, for two large-scale clinical endpoint bioequivalence trials in patients, conducted in the US and globally. We have been extremely happy with their performance. In our last study, database lock occurred approximately 24 hours after the last patient completed the trial! This could only happen with a dedicated team willing to work 24/7 with the sites and monitors to get the data into the database, queries resolved, and database locked in record time. In the competitive Generics business, one day can make a significant difference in whether the Sponsor will be "first-to-file" with the FDA." — Director, Clinical Development, Major US Client in Northeast US

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Device Sponsor

"We appreciate the ability to view our current data with TrialStat®'s customizable reports. Along with the standard metrics reports for management oversight this feature allows us to view unlimited combinations of data in real-time. We rely on TrialStat's project management team which has been very responsive and adaptable to our changing study needs."— Manager, Clinical Operations, Device Sponsor, Mid West US Region