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Fully Integrated Platform

Fully Integrated and Easy to Use. Right Out of the Box.

Evidex is a cloud-based, software-as-a-service platform built on next-generation technology and a best-in-class user interface.  Your IT and  QA groups will appreciate the minimal resources needed for implementation and your business users will gain access to the critical tools that they need and want to use. 

What's Included

Unlike other providers, with Evidex everything you need is in one spot, modular, fully integrated, and ready to use off-the-shelf. Signal detection, management, analytics, and more.

All of the main PV functions are available in Evidex "off-the-shelf".  We also work regularly to configure Evidex instances for clients to incorporate new functionality and data integrations.  The Evidex platform is built as a series of integrated modules that can be configured to meet any combination of client needs. This modular architecture enables our developers to quickly prototype new functionality and data integrations, which in turn enables rapid testing, feedback and iteration between the development team, partner integration and implementation team, and the project stakeholders.

All software engineering and data analytics are built, maintained, and serviced by Advera’s in-house team. Advera’s software development lifecycle (SDLC) is Agile development within the constraints of the GAMP-V model.  Validation documentation is authored by Advera during configuration and development and we work closely with our clients to determine the division of testing/qualification parameters.

Evidex is built on a 3-tier architecture pattern, with continuous integration and delivery (CI/CD) practices, which enables agile deployments. Each tier is configurable and scalable, allowing for regular data updates and product enhancements in a manner that ensures a seamless user experience.  We target 4-6 major product releases per calendar year and provide ample notice and documentation for all major releases to allow for QA testing and version controls.

Application & Data

- Hosting & infrastructure: Amazon Web Services (AWS EC2, AWS RDS; etc.)

- Data Persistence: MySQL & PostgreSQL on Amazon RDS & AWS EC2,

- Data Caching: AWS CloudFront; Redis;

- Backend languages and frameworks: Python

- Frontend languages and frameworks: JavaScript ES5 + AngularJS

 

Data Analysis Stack

- Data warehousing: PostgreSQL; AWS RedShift;

- Data analysis: R; Python;

- Machine learning/NLP: Python scikit-learn; Apache cTAKES;

- Data Integration / task automation: Python; Pentaho Data Integration;

- Human data analysis: MS Excel, R

 

Development Operations ("DevOps")

- Task & Issue management: Atlassian JIRA

- Version Control System: Git (GitHub)

- Automated Testing (CI): Atlassian Bamboo;

- Automated Deployment of new applications (CD): Atlassian Bamboo

Evidex is a fully validated, commercial-off-the-shelf software platform.  We work with your IT and QA teams to ensure seamless validation.  We can provide URS, FRS, SOP, IQ and OQ documentation and can provide the framework for user acceptance testing for the PQ.  We have a library of related validation documents available for your use and for your teams to leverage.

What makes our data, analytics, and software better?

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Built on Web 2.0 technology

Evidex is cloud-native, software-as-a-service built on next generation technology with a best-in-class user interface minimizing resources needed for implementation and providing tools safety reviewers want to use.

 

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Best-in-class customer support

Your Evidex Product Specialist is always available to train new users, conduct refresher sessions, or answer questions on-demand. In-app chat support is available in Evidex as is an interactive, online user guide. 

 

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Off-the-shelf, validated data integrations

Signal detection and advanced analytics on FDA Adverse Event Reporting System (FAERS), WHO's VigiBase, and our proprietary clinical safety database are included from Day 1.  

 

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Ready to take the next step? 

Integrated Signal Management

Audit-proof your process by tracking safety issues from clinical trials as post-approval.

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Advanced Data Analytics

Uncover hidden patterns, unknown correlations, and trends to become a value-added partner to your organization

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