Integrated Clinical Enterprise

Integrated Clinical Enterprise

One of the biggest challenges that the Life Sciences industry has is to be able to integrate the information silos that exist from Discovery through Clinical Development and Commercialization. IT teams are now actively trying to overcome this challenge by bringing in tools and technologies that will either replace or enhance the IT systems and also integrate well either natively or through enterprise-wide integration frameworks.

Industry Challenges

  • Ability to collect right and clean data, preferably in electronic format
  • Improve capability to integrate internal, external and third-party data and perform meaningful analysis
  • Provide controlled data visibility and access to partners and other third parties
  • Leverage technological advances and decrease IT support costs
  • Simplify Clinical, Regulatory and Safety processes & systems
  • Improve “Time-to-market”

Why TAKE

Orpine Systems understands the clinical data lifecycle quite well due to their extensive experience in working with global life sciences organizations and helping them with clinical data integration and standardization. Leveraging this experience and Oracle’s Health Sciences Suite we have developed a ‘OneClinical’ service offering. OneClinical

  • Technology and functional services offered by TAKE, powered by Oracle’s Health Sciences Suite and its products and accelerators
  • Caters to Clinical, Regulatory and Safety services areas of Life Sciences Research & Development
  • Provides Data Warehousing and analytics services that enable business intelligence by leveraging integrated data
  • OneClinical Customer Experience Center is an integrated set of tools from Oracle’s Health Sciences Suite as well as TAKE’s PharmaReady™ application, installed and available for customers to experience an integrated clinical enterprise. We have developed several solutions to enable integration between these applications and accelerators that enable rapid implementations
  • PharmaReady, our flagship product for regulatory electronic document management (eDMS), electronic Trial Master File (eTMF) and electronic common technical document (eCTD) submissions provides the technology solution for regulatory space
  • Orpine Systems has SafetyReady™, an accelerated solution for implementation, upgrade and migration for Oracle’s Argus Safety Suite.
  • Orpine Systems also offers Argus in a hosted environment through its SafetyReady™ Cloud solution

Services

Functional

  • Clinical Data Integration
  • Data Standardisation
  • Data Management & Biostatistics
  • Pharmacovigilance
  • eSubmission

Technology

  • Consulting
  • Implementation
  • Support
  • Hosting
  • Validation