Oracle^® Life Sciences (OLS) Application Services

Oracle Clinical
Oracle Clinical / Oracle AERS Hosting
Oracle TMS
Piloting Oracle RDC

Download our Oracle AERS Overview

Oracle^® Clinical Services

CSS Informatics is a leading supplier of consulting and development services for Oracle Clinical, a key component of the Oracle Life Sciences suite.  Over the past twelve years we have provided training, validation, re-engineering, implementation, and development services for Oracle Clinical environments at major companies in over 100 locations worldwide.

The CSS Informatics difference is clear: we employ top-notch technical and regulatory experts. Our team approach consistently provides our clients with a quality, comprehensive solution that allows them safely deploy each application.

Our Oracle Clinical consulting services include:

Training
Validation
Implementation and Support
Technical Operations

Oracle Clinical Services Data Sheet

Oracle^® Clinical / Oracle^® AERS Application Service Provider (ASP) Services

We were Oracle’s first authorized Application Service Provider (ASP) for pharmaceutical applications and continue to be Oracle's Preferred Provider for hosted OLS solutions.  As the largest, independent application service provider for Oracle Clinical and Oracle AERS, CSS Informatics offers a full range of hosting services for Oracle Clinical and Oracle AERS users.

Depending on your needs, we can provide:

Hosting service via our secured network access at one of our global data centers

Full technical support and operation of the infrastructure under regulatory compliant SOPs, including:
  - network management
  - systems administration
  - database administration (DBA)

A dedicated program manager to ensure needs are met and services are coordinated from initial launch of services and study startup

   through database lock and archival

End-user help desk services providing standard business hours or 24/7 phone support

Applications support targeted to help your staff use the system efficiently

On-site training and training materials

Validation packages and services

A full range of data management and programming support to supplement your resources

CSS Informatics is ready to partner with you to ensure that your data management and clinical staff have the technology and technical support needed to meet your clinical development goals.

Hosting for Oracle Clinical, Oracle AERS, Oracle TMS & Oracle RDC [pdf: 164k]

Oracle^® RDC

We offer a wide range of services to help you get started with Oracle RDC.  Our technical expertise with the Oracle RDC module and our clinical trial experience enable us to offer broad support for Oracle RDC technology.  As our parent company, PPD has implemented Oracle RDC with great success and combined it with PPD^® Patient Profiles to reduce review time before database lock.

We can provide:

Fully validated, hosted technical infrastructure to run RDC production or pilot studies
  - hardware
  - software
  - secure network environment
Full production or pilot study services on our hosted environment or your own installation
  - study setup
  - ongoing data management support
  - site setup services such as site surveys, qualifications, documentation, and installations

  - site support services

  - application support
  - 24/7 helpdesk
Program management from first pilot to full-scale implementation
Technical support for all aspects of the pilot
  - installation
  - configuration
  - validation
  - study setup
  - study conduct
  - closure and archive
A-la-carte implementation services
  - piloting
  - implementation planning
  - launch
Software development resources
  - add communication capabilities
  - add metrics reporting
Onsite and investigator site training and training materials

Customized training for investigator sites
Validation packages and services

We work closely with clients throughout the RDC process, while tailoring services to meet the needs of an organization.

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Oracle^® Thesaurus Management System (TMS)

We have extensive experience with commercially developed and custom coding technologies and have been development partners with Oracle, which allowed us to actively participate in the development of Oracle TMS.

Our Oracle TMS implementation and integration services include:

Installing and Implementing Oracle TMS

Designing and developing Oracle TMS search objects

Validating Oracle TMS

Standard and customized Oracle TMS 4.0.x and 4.5.x User and Administration training

MedDRA and WHODRUG dictionary loading

Creating virtual dictionaries

Load script development and mentoring

Creating gap analyses

Integrating Oracle TMS with Oracle Clinical and Oracle Adverse Event Reporting System (AERS)

Integrating Oracle TMS with external systems such as Empirica Trace™, Clintrial™, or SAS^®

Consulting experience with Oracle on the development of the TMS software