Regulatory

Our systems engineering experience provides the perfect foundation on which to build dependable, consistent, secure, accurate and attributable Internet-based applications conforming to all GCP requirements for Data Integrity, System Reliability, Management Control and Auditable Quality. TrialMaster is deployed in an Applications Service Provider (ASP) environment to afford maximum bandwidth and scalability. ASPs allow for increased data security and integrity across a medical-grade network while significantly reducing the total cost of ownership.

Compliance

All OmniComm applications are designed to be in full compliance with:

• International Conference on Harmonization and Good Clinical Practices (ICH-GCP)

• 21 CFR Part 11 Electronic Record and Electronic Signatures

• FDA's "Guidance: Computerized Systems Used in Clinical Trial"

Security/Privacy

For optimum security, OmniComm operates a multi-layer security method that places all study data two layers behind a hardware firewall, capable of providing 120 Mbps data throughput and up to 125,000 simultaneous sessions. In addition, all data is transferred using Secure Socket Layer (SSL) 128-bit encryption protocol and optional Virtual Private Networks.

Roles and Responsibilities

OmniComm's applications allow access to clinical trial information based on individuals' roles and responsibilities. The applications provide hierarchical user permission data entry, viewing and reporting options.