Adverse Event Intake System

UltraCLOUD

UltraCLOUD is a proprietary Ultragenic PV platform hosted on AWS and enabled with automation tools to offer a seamless integration of technology, infrastructure, and services, which frees up client’s time to spend on business-critical functions.

UltraCLOUD

The Challenge

Acquiring and implementing a drug safety system can often be a complex and time-consuming process. Organizations struggle with sourcing and coordinating technology demands, infrastructure needs, and implementation services from multiple solution providers. Moreover, the manual and repetitive tasks involved in setting up the environment can lead to errors, delays, and compromised quality.

How it works

UltraCLOUD is a Ultragenic PV platform with Oracle Argus Safety System at its core.UltraCloud leverages the power of AWS and automation to expedite the environment build process. Our platform seamlessly integrates technology, infrastructure, and services to deliver a comprehensive solution for our customers. Our standard onboarding framework involves the following :

Implementation methodology: We follow a proven implementation methodology that ensures a smooth transition and efficient onboarding of the client onto the UltraCloud platform.
Pre-defined configuration templates: Our extensive library of pre-defined configuration templates accelerates the setup process, reducing time and effort while maintaining consistency and best practices.
Standard validation kit: UltraCloud comes equipped with a comprehensive validation kit that ensures regulatory compliance, data integrity, and system accuracy.
Change management: We prioritize change management to seamlessly adapt to evolving business needs, ensuring the platform remains flexible and scalable as your organization grows.

We provide end-to-end hosting and implementation services to ensure that the client’s time is better spent on critical business outcomes.

UltraCLOUD Features

Infra Automation

Automations	Description	Benefits
Automated Infrastructure Build	UltraCloud offers advanced infrastructure automation capabilities. Traditional GxP infrastructure provisioning can be time-consuming, but with UltraCloud, we have created stacks on AWS CloudFormation to automate the infrastructure build process	A Faster infrastructure build time, reducing delays and accelerating project timelines Consistent implementation of security layers, ensuring regulatory compliance and data integrity
Argus Safety Installation	We have developed scripts to automate the installation of Argus Safety, including components such as Web, Database, Transaction, Interchange, and OBIEE/BIP	Validated Argus environment available within a day, significantly reducing implementation time Decreased effort required for Argus installation, enabling you to focus on core business activities
Axway Configuration	UltraCloud automates the configuration of Axway, specifically for Partner and Community setups, by utilizing Axway's published API.	Configuration of 200+ Partners and Communities can be completed in just a few minutes Streamlined Axway configuration, minimizing manual errors and ensuring accuracy

Limited validation during Implementation (Client Specific Configuration is only validated) due to Pre-validated Argus
Use Pre-build configuration templates to collect client specific configuration such as Product/Study/License/Users/Query Letters
Pre validated Argus Automations (Incl. Regulatory Related, Efficient Case Processing, Process Automations, Workflow Automations)

UltraCLOUD Key Benefits

On Infrastructure side
- Scalable and Available Infra – Hosted on Amazon Web Services (AWS) cloud enabling on-demand scalability
  - High Availability 99.99% guaranteed
  - Expedited procurement cycle for additional Resources.
  - Disaster Recovery (DR) setup with Cloud Endure offering Continuous Block level replication.
  - Minimal and configurable RPO/RTO
- Secure – A secure GxP environment
  - Separate Virtual Private Cloud (VPC) for client environments
  - Internet exposed gateway Servers in a Demilitarized Zone (DMZ) behind a Firewall
  - All other Servers are in a private secure subnet
  - Secure VPN access only
  - Anti-Virus on Servers
  - Encryption enabled for “Data at Rest” and “Data In Transit”
  - Monitoring Solution with Cloud watch
  - Automated Patching tool
- Flexible access option – Provides the flexibility to access via company network or AWS VPN
  - Integrates with Client AD, SSO, VPN
  - Integrates with external systems via secure site to site VPN
  - Allows easy loading and extracting Data via secure FTP by AWS
  - Database level access for read only users accessing via secure VPN
- Compliance – Continuous Total Compliance
  - Choice of hosting regions for primary and DR database meeting Data Privacy regulations e.g., GDPR
  - Compliant to all regulatory standards, e.g., PCI DSS, HIPAA, HDS
On Implementation side
- Faster implementation
- Standard Configuration
On Case Processing side
- Cost saving due to automation and standardization in Safety System
- Significant improvement in quality due to standardization
- Faster case processing due to automation driving error elimination and overall increased efficiency
- Easier hand-offs between workflow steps
- Scalable, Upgradable and Flexible to updates

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