EDC Systems

TFS has data management teams based in the US and Europe offering customers cost effective and flexible EDC technology, including OmniComm TrialMaster™ and Trial-on-Line.

OmniComm TrialMaster

OmniComm Systems, a leader in eClinical solutions, and TFS have a long-standing strategic partnership. This partnership provides our clients with exceptional services, with superior functionality. Through the use of innovative and progressive technologies, OmniComm and TFS provide eClinical solutions that address your unique clinical trial needs. These capabilities are only a few that make this partnership important to you.

  • Better query management allows assignments by role or user with workflow
  • Works with multiple browsers – IE, Safari, Firefox, Chrome
  • Dynamic Monitoring to help support Risk Based Monitoring
  • Standard reports that allow sorting, filtering and exporting to Excel and Word
  • Powerful Ad-hoc reporting tool for custom reports that include graphical visualization with scheduling, e-mail capability and personalized dashboards
  • Better integration with e-mail alerts
  • Easier to import multiple external data formats
  • Powerful export tool allows custom exports in different formats – ASCII delimited, true SAS Transport, CDISC SDTM
  • AJAX technology to provide guided data entry
  • Autoencoder and SAE Interface
  • IRT Interface
  • Embedded eLearning module makes training convenient for all end users

Security / Regulatory / Hosting

  • The data security is controlled with enforcement of FDA 21 CFR part 11
  • User access and read/write capability can be controlled in the system down to the question level
  • Data is transmitted via secured HTTPS
  • The system is fully HIPPA compliant with no identifying demographic for patients stored in the system
  • OmniComm internal SOPs support secure access to data and confidential information
  • The data is stored at a secure server hosting center
  • Data is backed-up to a data center
  • Nightly Tape Backup

Trial-on-Line

With the growing need for easy to use, cost effective and trustworthy Electronic Data Capture (EDC) systems, TFS offer Trial-on-Line, an EDC system that meets all criteria.

Appreciated for its ease of use and cost effectiveness, Trial-on-Line is fully compliant with industry and regulatory standards and provides features to ensure data security and accuracy. Trial-on-Line is used globally in all types of clinical trials (I-IV) and indications. Trial-on-Line is also suitable for Non-Interventional Studies as well as for investigator initiated studies.

Security / Regulatory / Hosting

Trial-on-Line is compliant with FDA 21 CFR part 11 and corresponds to GCP and FDA’s Guidance of Computerized Systems Used in Clinical Trials. To ensure data security over the internet, Trial-on-Line features 128-bit SSL (Secure Socket Layer) data encryption.

The Trial-on-Line service includes GxP qualified IT operations with redundant server, storage, communications, firewalls and backup service that is facilitated in a data center with very tough physical protection, redundant power supply, UPS, diesel generators and environmental systems.

Validation

A complete validation package is offered including training and access control. TFS also assists with the implementation and validation of the Trial-on-Line process and system in the customer’s environment.