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 hello@calyx.ai for additional information on Calyx RIM.

Background

The fact that the EU will soon be implementing standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP) is hardly breaking news. The life sciences industry has known about the impending adoption of IDMP for nearly a decade. However, the implementation timeline has been a moving target and for many companies this has meant that preparations for IDMP, originally begun in earnest, have understandably been deprioritized.

Publication of version 2 (and the very recent publication of v2.1) of the IDMP implementation guide by the EMA earlier this year makes it highly likely that in 2022 companies will be able to begin their IDMP iteration 1 submissions, with this becoming mandatory for centrally approved products (CAPs) in 2023.

MAH Guide to IDMP team development

Providing and maintaining standardized IDMP data will have a far-reaching impact across life science companies for those with products approved in the EU.

With the deadline finally on the horizon, life sciences companies need to regroup and ensure their data is ready for submission. Amidst numerous delays which have occurred over the last decade, extensive data quality assessments and revisions, and project scoping and budget requests, it is easy to forget what the original intention and purpose of IDMP was.

IDMP vs. XEVMPD

IDMP represents a substantial evolution of existing pharmacovigilance reporting requirements in the EU. In addition to the data points required by the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), the following will be required:

  • Manufacturing functions, processes, and registered sites for the active ingredient(s), intermediates, and finished product
  • Details on the administrable dose forms and strengths for each medicinal product
  • The manufactured item describing the authorised pharmaceutical form of the product and, where applicable, before transformation into the administrable pharmaceutical form
  • Packaging details including the packaged item container, quantity, and material for the inner and outer packs
  • Marketing status at the pack level, identifying which products/packs are on the market across the EU
  • Legal status of supply (Rx or OTC) at the product level where the same status applies across all packs; at the pack level where the status differs
  • Details on medicinal product composition including the origin of the ingredient, the composition grouping description and requirements to submit details for products subject to TSE, ASMF, CEP, VAMF & PMF certification

How IDMP will Make a Difference

The suite of five standards that compose IDMP have been developed in response to pharmacovigilance legislation enacted in the EU in 2012 (EU No 520/2012, articles 25 and 26). The legislation represented the biggest change to the legal framework for human medicines in a generation. The pharmaceutical industry and regulatory authorities went into the implementation planning fully aware that this would take years to deliver.

Under the legislation, all life sciences companies are required to submit detailed product data for all medicinal products approved or submitted for approval in the EU so that descriptors are common across jurisdictions. The standardized identifiers will eventually as the iterations progress provide a complete picture of every aspect of every product on the market – the indications approved, the marketing statuses, all product ingredients and manufacturers involved, down to the batch IDs.

The standards are designed to support the exchange of unambiguous and accurate product information across global regulatory and healthcare communities. The overarching goal and driving force behind IDMP is to improve patient safety through stronger pharmacovigilance and risk management. “Adverse event reports will be based on a harmonized set of product definitions, improving the quality of data used for signal management and speeding up communication, decision-making and regulatory action.”[1] The whole system will be built on a data-centric approach using structured content so that trends in safety issues will be easier to spot and sources traced more rapidly. Safety alerts will be easier to disseminate.

5,910

Full implementation of the PV legislation was estimated to save up to 5,910 lives per year and savings to society between 237 million and 2.4 billion Euros per year. [2]

Could IDMP have changed COVID?

The COVID-19 pandemic highlighted the criticality of structured data. With shortages in the drug supply and a dire need for global information sharing as the world has struggled to beat the virus, we can start to appreciate the value that IDMP will bring.

Imagine the power of a common data repository on adverse drug reactions related to virus treatments and vaccines… or the benefit of being able to analyse the data you are collecting for EMA to better manage the drug supply and avoid the kind of shortages experienced during the pandemic.

IDMP is just one of the structured data initiatives driven by EU Telematics, but the size of the data set and the cross-functional sources spanning regulatory, pharmacovigilance, manufacturing, and drug supply positions it for optimum impact. COVID-19 has proven the catalyst for change. Utilising IDMP to drive structured data governance across the industry will have far reaching benefits, the most important of which is patient safety.

Key Aspects of Compliance

The EMA has published several guidance documents explaining what will be required. The fundamentals are that:

— The EMA will create and maintain a Product Management Service (PMS), and information already residing in XEVMPD for marketed products will be migrated into the PMS. The product information will need to be qc’d and enriched via API submission to PMS to comply with IDMP requirements prior to any submission.

— When an application for marketing approval and subsequent lifecycle variations are submitted to regulators via the EU Centralized procedure, the IDMP data elements must be submitted as a Fast Healthcare Interoperability Resources (FHIR) message in the working documents folder of the electronic Common Technical Document (eCTD). This means that submitting the IDMP information is on a product’s critical path to regulatory approval.

— Having to provide the structured data at the time of submission is a significant shift from submitting XEVMPD data following receipt of approval as we do today. What this means in practice is that the regulatory authorities will have additional structured data to support their review of dossiers. Thus, Marketing Authorisation Holders (MAHs) need to ensure their Regulatory Information Management (RIM) system is up to date at all times and reflects data pending approval in addition to approved details. Aligning dossiers and data will be critical to companies moving forward.

The Time to Prepare is upon Us

In February 2021, EMA published the second version of the IDMP implementation guide, which makes it highly likely that compliance for CAPs will be mandatory in 2023 (the option to start transitioning will begin no earlier than February 22, 2022). The first step of the Targeted Operating Model (TOM) is currently being finalized and will cover CAPs only. The second step of the TOM will encompass non-CAPs.

Life sciences companies that have grown jaded over the subject of IDMP or that have put off preparations should dust off their plans and recommit to readying their organization.

A comprehensive IDMP readiness plan involves multiple components
Figure 1: A comprehensive IDMP readiness plan involves multiple components

Developing a comprehensive readiness plan will entail:

  • Engaging with the company’s RIM system vendor to ensure that the system will be capable of accommodating IDMP requirements over a product’s life cycle. Specifically, the RIM system will need to:

> Capture all the required Iteration 1 IDMP information, in logically presented fields

> Integrate automatically with source systems, according to their Application Programming Interface (API) needs

> Cross-reference data points so that information can be entered once and populated elsewhere as needed

> Create the IDMP data elements as an FHIR message and include them in the working document folder in the eCTD for submission to the agency and where appropriate, support direct submission to PMS

  • Determining the company’s priorities for enriching the data that already exists in XEVMPD on products in their portfolio (there will be at least a one-year transition period for centrally approved products). Which products and data elements should be addressed first?
  • In advance of updating RIM systems, MAHs can identify complex CAPs and map these to the IDMP requirements. This will be a valuable exercise to help ensure data owners across the organization are identified
  • Developing and implementing an organizational change management program with cross-functional representation, to encompass:

> Agreeing on data ownership and responsibilities

> Assessing significant changes to business processes

> Assessing the impact on outsourced work and external partners

> Delivering focused stakeholder education (to include third parties as needed)

Investing in the RIM team’s skill sets so that team members are equipped to serve as the company’s lynchpins in complying with the regulation. They will need to work across the organization to ensure that all stakeholders are aware of their responsibilities. The RIM team must also be capable of coordinating an effective quality control process, engaging with those planning submissions and preparing dossiers, and providing input into the evolving support model.

Conclusion

Picking up the adoption of IDMP standards will be a significant undertaking requiring careful planning and coordination across many internal functions and external partners. The objective of IDMP – to save patient lives – bears repeating, especially given the years that have elapsed since its conception: IDMP will make it easier to mine product data to safeguard patients. With that goal – and a looming compliance deadline – in mind, it is time for life sciences companies to resume their preparations accordingly.

REFERENCES

  • [2] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2671:FIN:en:PDF

Five Key Considerations

As the industry turns toward data-centricity, optimizing the management of your regulatory submissions and product data maintenance becomes ever more critical. Investment in strategic regulatory initiatives and Regulatory Information Management (RIM) capabilities continues to be a priority across the industry.

Five Considerations for Adopting RIM

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1. DATA QUALITY SUSTAINABILITY

Data governance, compliant regulatory submissions, extensive data sets for XEVMPD/IDMP compliance.

Use your RIM system for onward sustainability of these to manage your data and publish your structured data submissions.

Aligning with your day-to-day regulatory processes promotes sustainable data.

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2. OPTIMIZED PROCESSES

Optimized business processes are critical for a global regulatory team to operate effectively in today’s fast-evolving environment.

Harmonized processes across corporate and subsidiary operating sites:

  • Optimize resources
  • Reduce cycle time
  • Increase data quality
  • Ensure submission compliance
  • Decrease data entry burden
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3. REALIZED BUSINESS BENEFITS

Drive optimal performance by laying the foundation of your organizational strategy.

Process and system maturity promote trust in your data. Leverage that data to make informed business decisions.

Maximize your business benefits via strong data visualization capabilities in your RIM platform.

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4. ORGANIZATIONAL COMPETENCY

What is the outcome of organizational competency?

  • Harmonization
  • Standardization
  • Collaboration
  • Eliminated waste
  • Reduced costs
  • Accelerated product release

The bottom line? More effective operations drive more competitive advantages in global markets.

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5. CONNECTIVITY

Make the most of your best-of-breed systems throughout the organization.

Establish a source of truth and eliminate the distraction of extensive change management programs. The touch points from your RIM data to the rest of the organization make this paramount.

HOW TOP PERFORMERS ARE CONNECTED

Top-performing organizations are eight times more likely to have established a connection between their RIM system and Safety, and three times more likely to have established a RIM connection with product supply and product change control processes, compared to their counterparts.

What Can You Expect?

A modern and compliant system, Calyx RIM delivers:

  • Harmonized data and compliant, high-quality submissions
  • Expedited time-to-market resulting from improved processes
  • Operational and cost efficiencies
  • More focus on core competencies by regulatory resources
THE ABILITY TO TRACK, MINE AND ANALYZE DATA WITHIN YOUR RIM SYSTEM IS CRITICAL TO REGULATORY COMPLIANCE AND, ULTIMATELY, TO PATIENT SAFETY.

A Trusted Partner

Calyx uniquely combines regulatory cloud technology with the depth and breadth of our regulatory expertise to deliver a scalable and flexible RIM solution that yields predictable year-over-year savings and addresses regulatory complexities, increased workloads, and limited budgets facing the industry.

Calyx RIM for Office 365

Calyx and Microsoft together are delivering exciting new capabilities for our Regulatory Information Management (RIM) system that will change the way you work. It’s more than just a new feature — we have looked at the human factors of everyday regulatory operations tasks and workflows, and are introducing an entirely new way to interact with Calyx RIM.

The power of Calyx RIM, surfaced within Microsoft Office 365, elevates your productivity, utilizing machine learning and automation to simplify everyday tasks and bring RIM functionality into the tools where you already work.

KEY FEATURES

  • Access key Calyx RIM capabilities directly within Microsoft Office
  • Initiate submission workflows
  • Create or update sequences and references
  • Easily attach the target email and related attachments to the workflow
  • Automatically generate email notifications to keep interested parties updated on submission progress
  • Smart AI provides pre-population of data fields based on email content

Making the Complex Simple

Through automation and workflow — getting the right information and documents recorded in the right place — we take the compliance burden off the user to help ensure the process is done the right way every time. This eliminates multiple touchpoints and the back-and-forth emails and phone calls that are often needed to confirm everything is in the right place.

IMPROVE COMPLIANCE

By notifying you when a message from a regulatory authority is received, and facilitating the collection of required information without ever leaving Outlook, we help you adhere to compliance requirements effortlessly.

BETTER USER EXPERIENCE

By surfacing regulatory workflow directly in the tools with which you’re already comfortable, Calyx RIM for Office 365 is a huge leap forward for the casual user who does not live their lives in the RIM system every day.

Our technology partnerships are part of our commitment to, and passion for, innovation.

Calyx RIM for Office 365 is available through our alliance with Microsoft — indicative of Calyx’s longstanding and ongoing drive toward innovation. Built on Microsoft Azure, an open, enterprise-grade, secure cloud computing platform, Calyx RIM for Office 365 brings together Calyx’s global biopharmaceutical expertise with Microsoft, the world’s largest software company. This world-class cloud architecture is designed to deliver cost-effective innovation while safeguarding sensitive information and ensuring that data are properly managed and protected in a dedicated, private environment.

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