TrialOne is the leading proactive eSource and early phase site automation solution for your early phase clinical sites.

Early phase trials are the foundation of the research and development industry, helping life science companies build laboratory ideas into life-enhancing medical treatments for patients. Bedside Data Collection (BDC) solutions are a vital part of that process and enable early phase researchers to make clinical assessments as quickly as possible.

BDC provides an automated solution to paper-based processes. With TrialOne, sites no longer have to enter data on paper forms and later transcribe that same information into an electronic system. Sites can avoid paper based, time-consuming processes and make time-sensitive decisions with greater efficiency.

Automation can improve productivity for several areas within an early phase clinic. Whether it is volunteer recruitment, real-time study data collection, sample tracking, data management or reporting, TrialOne will handle all your early phase study needs.

This browser-based, tablet-compatible system provides an advanced platform for automating your clinic operations, complies with FDA 21 CFR Part 11 and supports standards such as CDISC for easy export and data reporting.

TrialOne capabilities include the following:

  • Comprehensive integration with a wide range of bedside patient monitoring, telemetry and clinical devices for real-time direct data capture of vital signs, ECG, body measurements, as well as the ability to attach files such as ECG traces.
  • Searchable volunteer database for running recruitment campaigns with the ability to track interactions and maintain a status of current and past clinical trial participation.
  • Ability to track samples through the clinic plus order and import lab results, enabling clinic staff to quickly and effectively respond to safety issues.
  • Study team electronic notification alerts of research participant’s data or experiences, allowing them to take appropriate clinical action and medical intervention.
  • Treatment blinding and allocation allows researchers to effectively track drugs per research participant for adherence to clinical plan and dosages, ensuring protocol compliance.
  • Comprehensive array of data management capabilities, including time tolerances, soft and hard parameter ranges, calculations, traditional edit checks, query management, study locking and exporting data.

Your onsite clinical research team has one main job — caring for volunteers.

TrialOne is a comprehensive set of modules that drive efficiencies, reduce timelines and reduce costs through faster and more directed volunteer recruitment; easy-to-build, schedule-based workflows; real-time, bedside data collection; direct data capture from devices; sample-processing automation and modern data processing. The browser-based, tablet-compatible system provides an advanced platform for automating your clinical operations, complies with FDA 21 CFR Part 11 and supports CDASH data standards for faster and easier exporting and reporting of data. TrialOne is designed and developed by early phase experts to deliver early phase trials in a way that is adaptable to the way you work.

T1xpress: a Prefab eClinical Solution to Automate Phase I Research

Early stage researchers, including Phase I Clinics and Units, with limited resources now have access to T1xpress, a new eClinical research option designed to accelerate and enhance clinical operations.

With preset configurations, T1xpress enables researchers with limited resources to automate their facilities and quickly launch clinical studies.

Researchers gain easy and automated access to data capture, sample tracking, data exporting and Exago custom reporting hosted in the OmniCloud™. The package also includes standard process workflow diagrams, a validation starter kit and a “quick-start” implementation schedule.

T1xpress capabilities include the following:

This prepackaged and fully hosted turnkey solution will allow for a much shorter implementation schedule, affording smaller clinics all the benefits of a tier I solution at a much lower total cost of ownership.

  • Recruitment, Data Capture, Tracker, Data Exporting and Exago custom reporting hosted in the OmniCloud
  • Preconfigured library, barcoded label templates and system roles
  • Preconfigured recruitment screens
  • Simple and fast data migration option
  • Standard process workflow diagrams
  • Validation starter kit
  • Fast implementation schedule: approximately 6 months
  • Expert support from OmniComm’s Professional Services Team

Anju Software provides leading, strategic eClinical solutions for clinical trials around the globe.

Anju is dedicated to the process of enhancing a patient’s quality of life by reducing the time to market of essential life-saving treatments.

Pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers partner with Anju to maximize the value of their clinical research investments and to develop safe and effective healthcare treatments for patients.


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