ESolutions



Clinicopia Suite

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

Catalent’s Informatics team develops, markets, and supports best-of-class, mission-critical information systems that enable customers to manage their clinical supply chain.  Our Clinicopia Suite and Clinicopia Enterprise Reporting products provide users with complete end-to-end control and visibility of their investigational product supply information.

Clinicopia Suite

Effective clinical supply management requires a tool that has the power of an enterprise resource planning system  that takes into account the regulatory and operational complexities the clinical supply manager faces on a daily basis.  The Clinicopia Suite was built specifically for this purpose by professionals with expertise in the clinical supply process.  The suite consists of these modules:

  • Clinicopia Forecasting – a comprehensive clinical demand management system
  • Clinicopia Supply Management – end-to-end inventory tool that covers supply planning, manufacturing, randomization, packaging, release and distribution
  • Clinicopia Labeling – clinical label translation, design, approval and printing
  • Clinicopia Process Execution – manufacturing and packaging instructions, resource planning and electronic batch records
Forecasting

Clinicopia Forecasting is a comprehensive planning tool for the clinical supply chain.  The users simply enter in study designs and dosing and the tool calculates the amount of kits, the dosage form, and all required active ingredients.  The clinical supply planner can analyze different study scenarios with different dosing and/or enrollment patterns to see the impacts on the study supply.   Clinicopia Forecasting also can aggregate demand across different protocols as well as products to provide overall drug requirements at the enterprise level. Designed specifically with clinical forecasters in mind, our system:   

  • Replaces numerous planning spreadsheets having complex calculations
  • Provides scenario analysis
  • Takes into account expiry dating in demand calculations
  • Aggregates demand across the enterprise
  • Integrates into the Supply Management system avoiding double-data entry
Supply Management

The Clinicopia Supply Management system is a tool with enterprise-level functionality that addresses the very unique requirements of clinical supply management. The scope of the system encompasses everything from receiving components for dosage form manufacturing through the shipment and returns of the packaged patient kits.  Users ranging from clinical supply managers to warehouse operators to CRAs to quality and regulatory staff utilize Clinicopia Supply Management to view, track and control all of the activities related to the investigational product supply.  The software is ready ‘out-of-the-box’ to manage the complex supply chain with little or no customization.  System functionality includes:

  • Inventory receipt, control and genealogy tracking
  • Manufacturing bills of material and processing
  • Patient kit design, approval and packaging
  • Randomization creation and/or import
  • Quality status and expiry/retest date management
  • Regulatory approvals for sites, lots and countries
  • Ability to receive packaged kit & genealogy data from CROs
  • Shipment order entry, processing and returns
Labeling

The clinical labeling process for the investigational product supply can be complicated, time-consuming and often a rate-limiting step in the clinical trial timeline.  The Clinicopia Labeling system incorporates label translations, label design, label approval and label printing into a single tool, enabling clinical supply planners to turn around labels more rapidly than was previously possible.  It also avoids the need to re-enter the label data into the label generation system which typically occurs with most other systems.  Integration with the Clinicopia Supply Management system allows users to track each individual packaged material through the entire inventory system and verify assembly of each patient kit to ensure accuracy.  Key features of Clinicopia Labeling include:

  • A phrase library that can be used for rapid label design utilizing foreign languages
  • Electronic routing of labels for rapid approvals
  • Integration with Clinicopia randomization capabilities
  • Integration with Clinicopia packaging runs
  • A feature-rich graphics editor to create WYSIWYG label designs
  • Full traceability of all printed labels by barcode scanning
  • Support for 2D & QR barcodes as well as right to left languages like Hebrew
  • Option to implement as a stand-alone system
Process Execution

Unlike the repetitive nature of commercial pharmaceutical manufacturing and packaging, the clinical supply management process often involves utilizing a unique process for each batch produced.  Automating the batch instructions and electronically capturing the execution activities in this environment requires a very flexible electronic batch record system.  Clinicopia Process Execution was built specifically to accommodate these special requirements.  System features include:

  • Recipe management for manufacturing and packaging
  • Batch instructions
  • Process-based execution of instructions
  • Electronic documentation of operations
  • Resource scheduling and planning
  • Automated weigh and dispense capabilities