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SmartSupplies PMD

This easy to use, fully web enabled solution empowers Biotechnology and Pharmaceutical organizations of all sizes to effectively Plan, Monitor and Control the clinical supplies process.

Bracket’s SmartSupplies PMD solution provides a protocol driven framework coupled with bidirectional integration to manufacturing systems (ERP), IVR services and B2B partners. With SmartSupplies PMD, Clinical protocol requirements are translated into accurately packaged and distributed investigational drug products. SmartSupplies PMD is designed to dramatically increase the efficiency, accuracy and compliance of the clinical supply process with immediate benefits including:

Planning

  • Clinical Protocol Driven Framework
  • Easily design and capture complex protocol stratifications
  • Supports all study types and randomization methods
  • Model subject kits and ancillary supplies

Manufacturing

  • Design multi-level subject kits and Bill of Materials
  • Supports blinded materials
  • Create and track Manufacturing Requests
  • Allocate lots to one or more Manufacturing Requests
  • Pool materials across multiple studies

Packaging and Distribution

  • Management of internal and external packaging efforts
  • Submit, approve and track shipment requests
  • Execute manual and IVR initiated shipment requests
  • Prevents distribution to unauthorized sites or countries
  • Prevents distribution of non-released materials
  • Monitor shipping status online

Management & Control

  • Subject Kit Level granularity
  • cGMP and 21 CFR Part 11 compliant
  • Regulatory Control to prevent distribution to unauthorized sites or countries
  • Effective management of clinical programs, studies, investigational sites and investigators

Integration & Communication

  • Integrates with CTMS systems, ERP Systems, IVR Services and B2B Partners
  • Provides Unified, Single Reference between departments, investigational sites and B2B partners

 


 

SmartSupplies RAR

This easy to use, fully web enabled solution empowers Biotechnology and Pharmaceutical organizations of all sizes to effectively perform Reconciliation, Accountability and Returns.

Bracket’s SmartSupplies RAR solution was designed by clinical teams. SmartSupplies RAR identifies the materials that need to be reconciled and provides both Online and Remote data entry modes. Reconciliations performed using the remote mode, can easily be imported back into the SmartSupplies RAR application to synchronize the data.

Features

  • Combines shipment, return, and reconciliation histories to provide Rapid Stock Recovery requirements
  • Identifies the materials that need to be reconciled at each investigational site
  • Perform rapid reconciliations in either online or remote data entry modes
  • Upload site reconciliation forms/worksheets for easy tracking of information
  • Combine site shipment history, return history, and reconciliation history to establish current reconciliation needs

 

  • Provide explanations for any deviations or problems encountered
  • Maintain the blinding of materials during reconciliation process
  • Allows for multiple reconciliations until all materials have been fully reconciled
  • Generate Online returns for partially used or unused inventory
  • Attach return drug management forms/worksheets and shipping invoices to return requests
  • Track and update the status of returns with ease

 


 

SmartSupplies Forecasting

This easy to use, fully web enabled solution empowers Biotechnology and Pharmaceutical organizations of all sizes to effectively forecast clinical supplies requirements for a clinical study or an entire clinical program.

Based on the principles of a Clinical Trial, SmartSupplies Forecasting enables forecasters to model study protocols, enrollment and material requirements to produce time-phased demand schedules that are easily modified and shared between departments. Forecasting the demand is only half the equation. SmartSupplies Forecasting is also designed to enable the Clinical Manufacturing team to develop manufacturing scenarios for meeting the forecasted demand. These lot-based scenarios factor in yields, lot expiry dates, reserves and more.

Bracket’s SmartSupplies Forecasting solution provides a protocol driven framework coupled with optional integration to ERP/MRP systems, IVRS systems and CTMS systems. With SmartSupplies Forecasting, Clinical Forecasters and the Clinical Manufacturing team share mutual benefits that include:

Clinical Forecaster

  • Clinical Protocol Driven Framework
  • Quickly forecast supplies requirements for a particular study or an entire program
  • Model complex stratifications, enrollment patterns, drop out rates and site initiation strategies to create multiple materials forecast scenarios
  • Model patient kits and ancillary supplies
  • Supports forecasting for titration and adaptive trials
  • Develop country specific forecasts
  • Update forecasts based on actual enrollment data
  • Effectively communicate the demand plan to clinical teams, management and manufacturing

Clinical Manufacturing Team

  • Review and define material overage requirements and predict material costs for a study or entire clinical program
  • Specify and communicate the supply plan to clinical teams
  • Pool materials across multiple studies
  • Predict demand requirements for Drug Substance, Drug Products and Patient Kits months in advance

Integration & Communication

  • Integrates with Clinical Trial Management Systems (optional)
  • Provides unified, single reference for clinical materials forecasting
  • Plan forecasted demand and manufacturing scenarios across departments

 


 

SmartSupplies LRA

SmartSupplies LRA provides a phrase and translation library to accurately record the phrases that are approved for use on clinical trial labels.

Import and approve translations and attach translation certificates directly within the phrase and translation library. Each phrase can then be approved for a particular country or countries, ensuring regulatory compliance throughout your labeling process.

The SmartSupplies LRA solution increases staff efficiency by allowing you to build re-usable templates – automatically associating the country-specific phrases with each new template, and allowing the user to customize the phrases to be included or excluded from a particular type of label.

Phrases

  • Record and approve official phrase text
  • Record and approve translations for multiple languages
  • Attach translation certification documents
  • Associate phrases with countries for automatic inclusion in label templates

Label Templates

  • Design re-usable label templates
  • Automatic population of country-specific phrases
  • Fine-tune control for inclusion/exclusion of phrases
  • View included phrases by country and/or language
  • Attach layout drawings and/or vendor specifications

Label Specifications

  • Create label specifications from approved templates
  • Incorporate static or variable run-time text such as Study No. or Med ID
  • View phrases and translations as they will appear on the label, by country and/or language
  • View attachments carried forward from template and/or add new attachments

Approval Routing

  • Configure separate default routing groups/routing order for templates and specifications
  • Supports parallel, sequential, and combination parallel/sequential routing
  • Fine-tune routing configuration for a particular template/specification
    Configurable e-mail notifications for each stage of the approval process
  • 21 CFR Part 11 compliant audit trail and approval/rejection history
  • Allows reviewers to approve, reject, revert approval, or delegate approval to another qualified individual
  • Provides complete visibility of routing process

 


 

SmartSupplies LDP

The label’s graphical design application is a GUI layout tool that allows users to quickly position phrases, variable text, drawing objects, images and barcodes on predefined label stocks.

Approved label designs can then be utilized in the web-based print request and completion application for the printing of production labels.

The LDP web-based printing application enables users to enter desired values for the variable data and import randomization files for a list of unique ID’s to be inserted into defined placeholders. The system’s powerful electronic routing and approval process verifies that the printed labels meet both study and packaging run requirements prior to printing.

All label designs (artwork) and printed labels are stored within the system’s secure database framework for improved reliability, scalability and universal access over the network.

SmartSupplies LDP can be purchased as a stand-alone product or as a fully integrated SmartSupplies product. When combined, the SmartSupplies LRA phrases and translations library and robust routing and approval engine provides unmatched capability for quickly producing labels that are compliant with industry and regional regulations.

Features

  • Easy to use graphical design tool
  • Supports all printer types
  • Allows for division of work between users who design label artwork and users who print production labels
  • Supports international languages, fonts, styles, barcodes, and graphics
  • Web based print request and completion workflow component
  • Prevents printing of non-approved labels and changes to artwork during printing process

Regulatory Compliance

  • Ensures 21 CFR Part 11 compliance and electronic signature capabilities
  • Full Audit Trail and Reporting
  • Group and user level security

Interoperability

  • Optionally integrates with SmartSupplies LRA to utilize a library of commonly used phrases & translations
  • Optionally integrates with SmartSupplies PMD
  • Provides email notifications to support the workflow of key process steps
  • Supports LDAP authentication
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