RFP

Calyx RIM

Uniquely combining innovative cloud technology with decades of regulatory and user experience, Calyx delivers a scalable and flexible Regulatory Information Management (RIM) solution that addresses the full complexity of today’s regulatory environment.

Calyx RIM provides a suite of integrated modules you can rely on to meet regulatory requirements worldwide, including submission planning, publishing, registration management, and more.

Learn why you can trust Calyx RIM to support you throughout every stage of your regulatory journey.

Publishing

Comprehensive, scalable submission publishing – compliant with global regulatory agencies

  • Wizards accelerate the creation of compliant submissions
  • Quickly create the necessary submission components including ICH, STF and regional XML files, leaf files, folder structures, and other required navigation aids
  • Create electronic (eCTD and NeeS) and paper submissions using a common user interface
  • Easily manage subsequent amendments, supplements, and variations within the context of the full application through the intuitive user interface
  • Create multiple submissions in multiple regions using comprehensive built-in templates
  • Be prepared for future formats such as RPS / eCTD 4.0
  • Validate eCTD and NeeS submissions using Validator, in accordance with Regional Agency specifications, creating comprehensive PDF reports for review and action
  • Out of the box connectors available to standard eDMS and fileshares – Functionality to compile group submissions
  • Linking and bookmarking tools for Word and PDF available
  • Select Package  offering available for smaller enterprises

Viewing

A unique application that supports collaborative review of regulatory submission content throughout the enterprise

  • Review eCTD and non-eCTD submissions
  • Quickly locate submission content using both document content and metadata via sophisticated indexing and searching functionality
  • Simultaneously review submission output and provide commentary without the risk of making any unintentional changes to content files
  • Search, report and distribute review comments for resolution – making true collaborative review a reality
  • Automatically register and update eCTD submissions from file system and/or EDMS repositories

Submission Management

Simplifying the dossier planning process and accelerating regulatory submission development

  • Create submission plans that include document placeholders prior to authoring
  • Assign new documents to the proper locations within the plan
  • Define and view version binding rules for documents used in the submission
  • Easily determine the submissions in which specific documents are used
  • Define milestones for each submission sequence and track planned versus actual dates
  • Order and group standard milestones to create Event Plans that ensure consistency, accuracy, and on-time delivery

Registrations

A tool for the centralized collection, management and tracking of detailed product information, registrations, and authorizations

  • Increase global coordination and collaboration between departments and affiliates by sharing a common authoritative information source
  • Manage and track Product Details through-out the life of the product
  • Manage projects that span multiple applications; information is entered once and replicated as appropriate
  • Track the status of the regulatory commitments and correspondence required to keep products on the market
  • Leverage electronic notifications to alert users of critical information updates

Workflows

Enable Workflows to match business processes within Calyx RIM

  • Cross-module, client specific processes allow for flexibility to enforce processes and improve data quality
  • Workflows can be configured to automate the data creation process, allowing for the capture, QC, and approval of data – ensuring first time quality
  • Track actual work time to determine issues, increase efficiency, and enable better, more accurate metrics
  • Manage workload, track progress & assignments, and increase efficiency
  • Native within the Calyx RIM platform – no external tools or systems necessary

XEVMPD

Maintain product data, create compliant submissions, process agency acknowledgments required by EMA pharmacovigilance legislation

  • Effectively maintain the product information and controlled vocabularies via standard create, read, update, and delete operations
  • Standardize and harmonize data sets that meet EMA requirements using a high-performance, pre-configured Oracle database
  • Create the XEVPRM ZIP files for both initial and updated submissions and submit to EMA via your gateway using the web-based Submission Wizard
  • Process the EMA acknowledgment files and update the corresponding EV codes within the XEVMP database using the web-based Acknowledgement Wizard
  • Fully integrated into the wider RIM capabilities, including reporting, task management, etc.

Calyx RIM IDMP

  • Logical integration of 100% of EMA iteration 1 datapoints in your day-to-day use of the Calyx RIM Registrations & Product Detail Management Module
  • Integration and synchronization with the EMA SPOR Master Lists for Organizations and Referentials.
  • Integration and synchronization with the SPOR Master List for Substances following finalization of the SMS
  • IDMP data collection templates available to facilitate an effective and efficient data migration for the initial data load
  • Proven IDMP & Data migration subject matter expertise to provide ongoing support and expert advice during an IDMP implementation project
  • System wizards to manage lifecycle changes
  • Our Product Management team in collaboration with IDMP SMEs are actively developing IDMP Data Visualization for availability in a future release
  • Our Product Management team in collaboration with IDMP SMEs are actively developing IDMP QC processes for availability in a future release

Outlook 365 Add-in

Remove the burden from end users so they can focus on getting drugs to patients

  • Workflow in Calyx RIM initiated from within Outlook
  • Optimize time for experts to strategize, compile, and finalize responses to HAQ
  • Streamline product supply & release processes
  • Achieve time to market efficiencies
  • – Each day not on the market is typically estimated as a loss of $1M

Analytics with PowerBI

  • Powerful business analytics tool to retrieve, mine and consume your data in any way that you require
  • Provides interactive visualizations and business intelligence capabilities
  • An interface simple enough for end users to create their own reports and dashboards
  • Considerable end users’ satisfaction and TCO benefits
  • Data as a Service (Azure SQL) also available for external reporting needs

Visit calyx.ai/RIM or contact [email protected] for additional information on Calyx RIM.


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