Overview

TrialOne® the leading proactive eSource and Early Phase site automation solution

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 import, export and data reporting.

TrialOne capabilities include the following:

  • Comprehensive integration with a wide range of bedside patient monitoring, telemetry and clinical devices with enhanced ability to send electrocardiography (ECG) orders to devices such as Mortara Surveyor Central System
  • Ability to read ECG tracings in real-time, 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
  • Enhancements in handling treatment blinding and allocation allows researchers to effectively track drugs per research participant for adherence to clinical plan and dosages, ensuring protocol compliance. Supports open-label (no blinding), single-blinding (participant blinded), double-blinding (floor staff blinded), and triple-blinding (data extract blinded)

“TrialOne will greatly improve our research environment. Not only will it automate many study activities, but it will also upgrade our clinical trials system by enabling more streamlined work flows. This will lead to a drastic increase in the quality of clinical trials and their related services to our valued clients.” Prof. Yung-Jue Bang, M.D., Ph.D., President Biomedical Research Institute SNUH and Director SNUH Clinical Trials Center

Subject Recruitment

A very time-consuming aspect of conducting a clinical trial is subject recruitment. Ensuring the right subjects are being put on the right studies is critical to timelines, resources and overall costs. TrialOne helps reduce the time it takes to get a more suitable subject population by letting you collect the data you need about each subject. The subject database is highly configurable and allows each site to customize their subject database. There are no limitations as to what information can be collected. TrialOne’s Criteria tool enables sites to quickly and easily search the database for those subjects who most closely match any study’s criteria or sponsor’s feasibility requirements.

TrialOne allows the clinic team to keep track of study advertising campaigns and a subject's interest in particular studies. Volunteers can be given appointments after successfully passing general or study-specific inclusion/exclusion criteria, allowing customizable study entry controls to be maintained when necessary. Automatic appointment reminder notifications and communications in the form of letters, emails, or text messages can be sent to subjects to remind them of upcoming visits. The staff can also track each subject’s visit, enrollment, dosing and other history over time.

Data Collection

Study data can be collected in TrialOne from offices, hospitals and universities throughout the world by physicians, nurses, and clinic staff using TrialOne's proactive real-time browser-based Electronic Data Capture system. The clear and intuitive data collection screens provide a responsive and user-friendly method of collecting the information that is most important for your clinical trial and business.

Electronically confirm volunteers into visits by scanning their subject barcodes and start collecting data immediately. Connect directly to medical devices for immediate and accurate results without the need for double data entry. Scan barcodes to verify the correct specimen container is being used or the correct dose is being given. Record the collection time with a hands-free USB attached footswitch.

Sample Tracking

Samples of all types collected at any time during the study can be tracked from draw through shipment or destruction. Lab staff can operate the extremely user-friendly interface through wall-mounted touch screen monitors to record the processing steps. Simple or complex pathways can be accommodated allowing for divergent pathways and multiple transfers.   Processing task timings can also be managed ensuring each step is performed per protocol or sample instructions. The staff can batch and un-batch samples at any time for bulk processing, storage and/or shipment.

Pre-printed sample labels are often required to be prepared for volunteers, samples, doses and other events in the study protocol. Quickly and easily design labels using NiceLabel Pro software which works seamlessly with TrialOne to create any variety of custom or standard labels and then print all labels directly from within TrialOne. As well as system generated barcodes, TrialOne supports external barcode labels, such as sampling kits, allowing the site to cater for all sponsor needs.