ESolutions



Clinicopia Enterprise Reporting

providing users with complete end-to-end control and visibility of their investigational product supply information

Clinicopia Enterprise Reporting extends Clinicopia capabilities by sharing information with Enterprise Content Management (ECM) and Business Intelligence tools.  It allows End Users to create their own ad-hoc management reports.  Clinical Supply chain managers can respond to ever changing information demands efficiently and quickly without any involvement of Catalent or local IT resources.

Catalent Informatics’ systems professionals provide a wide array of services to help our customers maximize the return on investment on their clinical supply chain systems.  We combine our domain expertise with our certified processes to provide deliverables that fully meet both functional and quality requirements.  We leverage the current technologies as well as our vast implementation and validation experience to facilitate efficient and compliant rollout of the most complex systems.  One client has stated on average their end users design reports within 20 minutes.  Our services include:

  • Implementation
  • Integration
  • Validation
Implementation Services

Implementing a new clinical supply chain system has profound impacts on the entire business, from senior management to operators on the line.  Catalent Informatics has an enviable track record in deploying applications at global sites.  Our implementation team has the experience and the proven methodology to enable an on-time and within-budget implementation.  Catalent Informatics’ project managers, business analysts and technical experts employ best practices to ensure our projects remain on schedule and produce the expected return on investment.  Our development center also has a proven record of delivering quality reports, interfaces and other custom software critical to many of our implementations.  Our services include:

  • System training
  • Business process consulting
  • Custom interface and report development
  • Installation and data migration support
  • Validation services
  • Post-production system support
Integration Services

The extended clinical supply chain spans across many locations and players and involves many systems.  Catalent Informatics’ data professionals have developed the Clinicopia Data Exchange tool which enables Clinicopia to easily share a wide variety of data with other mission-critical supply chain systems.  The tool consists of a comprehensive set of data messages which can be specifically configured by our systems experts for a particular interface as needed by a customer.  The flexible platform allows Catalent Informatics’ analysts to map data fields and set message triggers without affecting the functionality and validation state of the underlying applications.  Specific requirements and testing strategies are also developed as part of the process.  Systems our interface team has experience with include:

  • Clinical Trial Management Systems
  • IVRS/IWRS
  • Automated Warehouse Management Systems
  • Distribution Systems
  • LIMS
  • Randomization Systems
Validation Services

While Clinicopia is considered a ‘PQ/UAT Ready’ system out of the box, any GXP clinical supply chain system must undergo some level of testing and validation at the customer site prior to deployment.  GAMP V recommends leveraging the software suppliers’ validation wherever possible.  Catalent Informatics’ validation professionals provide a wide range of validation support activities, some of which rely heavily upon our comprehensive Validation Package.  This package contains the entire battery of tests as well as the trace matrices used by Catalent during our development and release of Clinicopia.   Our validation services include:

  • Validation Approach and Methodology Development
  • Mapping the User Requirements Specification to Clinicopia
  • Consultation on Best Use of the Validation Package
  • Custom Test Script Development
  • On-site Assistance in Test Script Execution