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Evidex Data & Analytics Introduction

Data cleansing & optimization, aggregating disparate safety data sources, custom analytical tools, and comparison reports.

Andrea Demakas avatar
Written by Andrea Demakas
Updated over 4 years ago

Introduction

Welcome to Evidex, Advera Health’s cloud-based, software-as-a-service platform built on next-generation technology and best-in-class user-interface for signal detection & signal management.

Evidex contains a market-leading off-the-shelf signal detection platform that aggregates data from multiple disparate sources to enable surveillance across all safety data that a life science company needs access to. Start with what you need access to on Day 1, and add on data sources as your company grows and needs evolve.

Evidex enables your team to identify safety signals from traditional sources like ICSR databases (Argus, ArisG, Veeva, AB Cube, etc.), FDA Adverse Event Reporting System (FAERS), VigiBase, EVDAS, VAERS, and Clinical Trial data. Expand to include new data sources such as Claims, EHR, MAUDE, EDC, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions.

Evidex also provides integrated or standalone Signal Management to help audit-proof your process by tracking safety issues from clinical trials through post-approval. This enables automated surveillance of any data source, fully integrated with a GVP-IX compliant signal management platform. Evidex enables you to identify and resolve safety signals from any data source with audit-ready and intuitive tools. Fully validated off-the-shelf based on GVP Module IX signal management guidelines, Evidex is flexible enough to meet any organization’s unique needs.

Click here to read more about our Signal Management module.

Signal Detection

For basic signal detection, out of the box data access includes cleansed, optimized, de-duplicated and mapped FAERS data as well as Advera’s proprietary Clinical Evidence database across more than 17k trials and counting, curated from clinicaltrials.gov. and updated by Advera's analyst team on a monthly basis. Advera prides itself on the quickest turnaround time for clean and optimized FAERS data in the industry – on average 5-7 days after the quarterly data are released by FDA.

This enables our clients to have access to the most up-to-date data available.

Evidex can connect to your company’s ICSR database such as ArisG, Argus, Veeva, etc. to enable automated surveillance of your internal database. Further, Evidex also connects to your Vigibase license, EVDAS data, EDC, Claims, or any other data source you may need access to.

On top of each data source, we have also built trending dashboards, Comparison Reports, and powerful custom analytical tools to enable our clients to get the most out of their data.

And last but not least, we take great pride in providing best-in-class customer support for both our paying clients, and prospects who may be on trial to evaluate Evidex.

Our in-house product specialist team is always available to train users, conduct refresher sessions, or answer questions on-demand.

Phone, email, and in-app chat support is provided for all Evidex users along with an interactive, online user guide and video tutorial library.

We look forward to providing you with the support you need to obtain the most value out of your data as possible. See our full video tutorial library from our Help Center to view videos on each tool.

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