Trial Online
EDC

All Trial Online EDC activities are managed on the Internet and offers a modern and easily accessible platform for all parties involved in a study.

Web based
No special hardware or software is required to run Trial Online EDC, which utilizes standard internet browsers. Since the start-up time and creation of electronic Case Report Forms is very short, Trial Online EDC can be used for all trials, regardless of size.
Construction of eCRFs and edit checks
The eCRFs are created in a construction module that is a stand-alone software. This module offers a fast and easy way to build eCRFs and edit checks, with flexibility in design and format. The module includes a library function where you can store and reuse standard forms. The eCRFs are easy uploaded in the Trial Online interface. Changes in the eCRFs during an ongoing trial is also possible and easy to handle.

Functions in Trial Online

Trial Online ensures the validation of data entry through edit checks that can be set to trigger directly when an “incorrect” entry has been entered, or in batches at regular intervals. Edit checks are easily specified in the Construction Module. Trial Online offers a paperless query tool to generate, resolve and track queries online. CRAs, Data Managers and Medical Coders can create queries and forward them to the investigator/coordinator who will be alerted within the system or via a system-generated email. Laboratory files can be imported into Trial Online. Excel, SAS, ASCII and PDF are standard export formats in Trial Online. It is possible to upload images, videos and other binary files in Trial Online. Files may be assessed by an independent investigator in the system

User Roles

All roles have access to Trial Online with defined permissions and passwords. When logged on, the system provides a clear project overview, specific To Do list and email alerts.

Following roles are available in Trial Online EDC:

  • Investigator
  • CRA/Monitor
  • Sponsor
  • Trial/System Administrator
  • Assessor
  • Coordinator
  • Data Manager
  • Medical Coder (MedDRA and WHO-DDE coding)

Reports

Trial Online includes several types of reports to simplify the overview, monitoring and security of the trial. In Trial Online the user can also create and customize additional reports. The Status Report Summary gives the user insight to work flow navigation and a visual overview of patient status.

Data is saved automatically

Store each value automatically once it is entered.
No risk of losing data due to inactivity.
Edit checks triggered directly for cleaner data.
More effective monitoring and cleaning process.

Audit trail

A complete audit trail is maintained from data entry through all changes in the system. The Trial Online system includes many types of reports that simplify the overview, monitoring and security of the trial and additional, customized reports are readily available.

Security / Regulatory

Trial Online is compliant with FDA 21 CFR part 11. Trial-on-Line also corresponds to GCP and FDA’s Guidance of Computerized Systems Used in Clinical Trials. To ensure data security over the internet, Trial Online features 256-bit https data encryption. The user is automatically logged out if no activity has been noticed during a predefined time.

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