|
|
|
|
|
|
Electronic Data CaptureQuality, Security + ComplianceFor a clinical trial to reach a successful conclusion, every aspect of its execution must meet stringent quality standards. UBC has established policies and procedures to address the quality of our clinical trial management systems in a comprehensive manner, from security to regulatory compliance, system development, and ongoing project support. We continually review, refine, and update these policies and procedures to ensure the quality our clients demand. Quality of ServiceOur track record and longstanding client relationships are a testament to the individualized attention we give to each project throughout its duration. Our service commitment includes:
Project-Centered Quality ControlAt the project level, we ensure quality through an iterative design, development, and approval process in which our clients are integrally involved. The Software Development Life Cycle methodology includes:
SecurityUBC deploys industry standard security measures for our web systems including secured socket layer technology and 128-bit encryption. Our systems are designed using role-based architecture to ensure only authorized users are capable of viewing specific information. CompliancePrinciples set forth in regulatory standards such as Code of Federal Regulations (21 CFR Part 11), GxPs, Health Insurance Portability and Accountability Act of 1996 (HIPAA), and International Conference on Harmonization (ICH) guidelines are the foundation of our quality program. These standards are supported by:
Disaster RecoveryUBC employs a decentralized IT infrastructure consisting of multiple and geographically dispersed data centers. All UBC data centers are managed by UBC IT staff. Our disaster recovery and business continuity strategies leverage this architecture by designating certain data centers as backup and hot sites for other data centers. UBC data centers are located in:
|
United BioSource Corporation |
||||||||||||||||||||||||
