Oracle^® AERS Consulting, Hosting, Data Migration and Validation Services

Experience with Oracle AERS

CSS Informatics is the most established drug safety software consulting practice in the industry with more than eighteen years of continuous innovation and support.  Our team of well-educated, industry-proven experts has an average of ten years of pharmaceutical technology experience and we understand how adverse drug reaction reporting software like Oracle AERS can improve your compliance and efficiency. 

We are privileged to call many top fifty pharmaceutical companies our clients and we have served small and mid-sized companies equally as well.  In fact, more than 150 pharmaceutical and biotech companies on five continents have found successful solutions through our consulting services since we began in 1990.  And, as a division of the billion-dollar CRO PPD (Nasdaq: PPDI), we have stability and staying power.

We began consulting with Oracle AERS shortly after Oracle acquired EventNet in 2002.  Soon thereafter, CSS Informatics participated with Oracle Corporation in a joint development relationship around Oracle's Thesaurus Management System (TMS).  Since then, CSS Informatics has provided Oracle AERS implementation, training, data migration, validation, and hosting services to dozens of clients in the U.S. and Europe.  Today, while others promote their past role in developing this software, CSS Informatics is proud that we're making it better!

Our Oracle AERS experience is wide-ranging and has included projects such as: 

Installation, configuration, and customization

Product Complaint Tracking

Supplemental staffing and business hours support

E2b electronic reporting
MedDRA implementation and upgrades
Data migrations from systems like Empirica Trace, Argus Safety and ARISg into Oracle AERS
Oracle AERS and Oracle database version upgrades
System validation services

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Oracle AERS Services

We believe we offer the most comprehensive set of Oracle AERS services available from one company.  Every service listed below represents actual expertise that we've gained from real client projects.

Oracle AERS Installation and Configuration

CSS Informatics has successfully completed numerous Oracle AERS installations.  These range in nature from production client systems, to hosted environments, to our own internal infrastructure.  We are confident when we say that the breadth and the scale of our experience in this area is comparable to few others.

Oracle AERS Training

We were a leader in pharmaceutical software training long before Oracle AERS was on the scene.  Even today, we provide regular AERS training at client facilities around North America and Europe.  In fact, we have trained more than 4,000 users on Oracle's Life Sciences applications alone.  Rest assured that our Oracle AERS material is current, comprehensive, and client tested.

Oracle AERS Data Migration

Since 1995, CSS Informatics has migrated 150 clinical and safety data environments.  Our proven, proprietary tool, TableTrans®, helps accelerate the mapping and source code generation process.  And, yes, we've done data migrations with Oracle AERS.  We can help.

Oracle AERS Validation

It's not enough to install Oracle AERS and know how to use it.  Regulations require this application to be validated and CSS Informatics has been validating drug safety systems longer than our competitors have been in business.  Plus, we have existing, project-ready validation packages for Oracle AERS that have been proven and refined by numerous projects.

By tapping into PPD's multi-million dollar, global IT infrastructure and data centers, CSS Informatics has built the largest, independent Oracle Life Sciences (OLS) hosting service in the world.  We are Oracle's Preferred Provider for OLS hosting and we've consistently proven our value and reliability.  Even if your company doesn't need hosting services, you can rest confident that the experience we've gained through our hosting business will bring additional value to your Oracle AERS project.

Oracle AERS Staff Augmentation

As experienced resources become harder to find or internal budgets restrict new headcount, CSS Informatics has been pleased to provide full- and part-time staffing solutions.  Our professionals are the same skilled consultants that we would provide for project resourcing and we guarantee that our people are proven, W2 employees of CSS Informatics.  We have active staffing engagements on both the east and west coast of the U.S. and references are always available upon request.

Oracle TMS Expertise

Oracle AERS Enhancements

Even Oracle AERS doesn't do everything.  There are no shrink-wrapped, push-button data migration scripts.  For that we provide TableTrans®. 

And, while Oracle AERS generates an E2B file nicely, it doesn't provide gateway or web-browser software to transmit ICSRs and monitor their status.  For that we offer our E2B ICSR Browser.

Finally, there are reports, triggers, and data checks that take time and experience to work through properly.  And for that we offer our people – the most valuable resource we have.

Contact us for more information about our Oracle AERS services