SafetyReady™ Cloud

Providing technology solutions and services to fulfill the ever changing and more stringent regulatory requirements of life sciences organizations is a challenge. This becomes even more challenging when it comes to patient safety. IT teams are challenged to effectively deploy and maintain critical applications with lower budgets and staff constraints.

Business Need

• Low total cost of ownership (TCO)
• Predictable IT spending on Safety & Pharmacovigilance system
• Accelerated deployment of Oracle’s Argus Safety Suite
• Efficient and compliant validation of Oracle Argus Safety Suite
• On-demand scalability
  

Service Highlights

TAKE’s SafetyReady™ Cloud provides the most cost-effective way for an organization to acquire SafetyReady™ capabilities. With this solution the organization will have an Oracle Argus Safety based integrated platform for end-to-end pharmacovigilance solutions, ensuring regulatory compliance and comprehensive product oversight, from clinical development to post-marketing surveillance.

TAKE's hosting services include:

• Secure Hosting – validated environment hosted at a state-of-the-art facility supported by a dedicated group of Oracle Argus specialists
• Administration and Configuration - options allowing the users to tailor the system to meet specific business needs
• Business Process Orchestration - system workflows and settings designed to industry best practices, while still being customizable to the users’ needs
• Dictionary Management – maintaining of the MedDRA and WHO drug dictionaries and performing dictionary upgrades as new versions become available
• Validation Readiness – readily available test scripts required for implementing the system and conforming to the validation requirements set by the 21 CFR Part 11
• Support – 24x7x365 support catering to the organization’s helpdesk services, application support and infrastructure support needs.