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.
- 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
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.
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