R&D Consulting Services - Paragon

Clinical Optimization

  •   Overview   

    Paragon’s Clinical Optimization Practice focuses on improving the operations of your clinical teams. We support the entire lifecycle of clinical trials: from study planning through clinical study reporting, as well as across the various functions in R&D, from medical writing through monitoring and clinical data management. Areas of focus have included, but are not limited to, study start-up, site collaboration, monitoring optimization, TMF management, and CRO and operations oversight.

    Data Sheet: Clinical Optimization Overview

    VIEW THE DATA SHEET

  •   Investigator Collaboration   

    One of the key ways in which an organization can improve collaboration with sites is by implementing a clinical portal. This improved collaboration can improve study timelines, increase compliance with regulations, and improve the overall relationship with sites. Paragon has worked with numerous clients (sponsors and CROs) to successfully implement clinical portals (both Transcelerate and 3rd party tools), and has team members who have spent many years focusing on site collaboration.

    Paragon’s team of experts can help you select and implement a clinical/site portal that can improve collaboration with external partners (sites, CROs, 3rd parties). 

    We can support your clinical portal initiative by:

    • Guiding need identification and solution selection
    • Defining processes that maximize the capabilities that the portal provides
    • Designing, developing, and validating integrations with internal and partner eClinical systems
    • Driving adoption by creating and delivering communications and training to all impacted stakeholder groups
  •   Electronic Trial Master Files (eTMF)   

    A complete and inspectable trial master file is one of the two main outputs of any clinical trial. However, many organizations struggle to satisfy this expectation. Paragon has worked with upwards of 20 organizations to improve their TMF management and drive inspection-ready TMFs. We have experience helping organizations of all sizes (small biotechs to top 5 pharma), focus (sponsors and CROs), and operating models (entirely insourced to mix to entirely outsourced.) 

    Our team of experts can help your organization:

    • Determine which content needs to be maintained as part of your TMF, and who is responsible for it
    • Decide where you store this content (in-house eTMF, CRO eTMF, paper, etc.)
    • Design the optimal processes for creating/processing content and performing TMF QC/QA
    • Implement an eTMF or improve your use of the tool via process/configuration optimization

    Executive Brief: Impact of E6 R2 on eTMF

    DOWNLOAD THE EXECUTIVE BRIEF

    Data Sheet: Electronic Trial Master File

    VIEW THE DATA SHEET

  •   Risk-Based Monitoring   

    If your organization is not integrating the data held in IVRS, EDC, CTMS and other systems to create a unified picture, they are missing an opportunity. Your company’s clinical data assets can feed into a custom dashboard, allowing it to be monitored from a centralized location and supplemented by more strategic (and potentially less frequent) site visits. Our Risk-Based Monitoring model will deliver significantly improved value for your company’s efforts. Our industry experts will guide you in making a strong business case for the benefits of Risk-Based Monitoring, including regulatory compliance, better use of resources, and greater value from your company’s investment.

    We bring together deep domain expertise in Life Sciences, Document Management, and Business Process Management to help you:

    • Ensure human subject safety
    • Achieve better data quality and better use of data
    • Improve compliance with regulations
    • Reduce risk profiles by identifying and addressing struggling clinical sites
    • Reduce costly site visits by shifting to reliance on offsite data monitoring
    • Maximize value and ROI from monitoring efforts
    • Eliminate unnecessary site visits, making every visit more valuable

    Data Sheet: Risk-Based Monitoring

    VIEW THE DATA SHEET

  • Paragon’s Clinical Optimization Practice focuses on improving the operations of your clinical teams. We support the entire lifecycle of clinical trials: from study planning through clinical study reporting, as well as across the various functions in R&D, from medical writing through monitoring and clinical data management. Areas of focus have included, but are not limited to, study start-up, site collaboration, monitoring optimization, TMF management, and CRO and operations oversight.

    Data Sheet: Clinical Optimization Overview

    VIEW THE DATA SHEET

  • One of the key ways in which an organization can improve collaboration with sites is by implementing a clinical portal. This improved collaboration can improve study timelines, increase compliance with regulations, and improve the overall relationship with sites. Paragon has worked with numerous clients (sponsors and CROs) to successfully implement clinical portals (both Transcelerate and 3rd party tools), and has team members who have spent many years focusing on site collaboration.

    Paragon’s team of experts can help you select and implement a clinical/site portal that can improve collaboration with external partners (sites, CROs, 3rd parties). 

    We can support your clinical portal initiative by:

    • Guiding need identification and solution selection
    • Defining processes that maximize the capabilities that the portal provides
    • Designing, developing, and validating integrations with internal and partner eClinical systems
    • Driving adoption by creating and delivering communications and training to all impacted stakeholder groups
  • A complete and inspectable trial master file is one of the two main outputs of any clinical trial. However, many organizations struggle to satisfy this expectation. Paragon has worked with upwards of 20 organizations to improve their TMF management and drive inspection-ready TMFs. We have experience helping organizations of all sizes (small biotechs to top 5 pharma), focus (sponsors and CROs), and operating models (entirely insourced to mix to entirely outsourced.) 

    Our team of experts can help your organization:

    • Determine which content needs to be maintained as part of your TMF, and who is responsible for it
    • Decide where you store this content (in-house eTMF, CRO eTMF, paper, etc.)
    • Design the optimal processes for creating/processing content and performing TMF QC/QA
    • Implement an eTMF or improve your use of the tool via process/configuration optimization

    Executive Brief: Impact of E6 R2 on eTMF

    DOWNLOAD THE EXECUTIVE BRIEF

    Data Sheet: Electronic Trial Master File

    VIEW THE DATA SHEET

  • If your organization is not integrating the data held in IVRS, EDC, CTMS and other systems to create a unified picture, they are missing an opportunity. Your company’s clinical data assets can feed into a custom dashboard, allowing it to be monitored from a centralized location and supplemented by more strategic (and potentially less frequent) site visits. Our Risk-Based Monitoring model will deliver significantly improved value for your company’s efforts. Our industry experts will guide you in making a strong business case for the benefits of Risk-Based Monitoring, including regulatory compliance, better use of resources, and greater value from your company’s investment.

    We bring together deep domain expertise in Life Sciences, Document Management, and Business Process Management to help you:

    • Ensure human subject safety
    • Achieve better data quality and better use of data
    • Improve compliance with regulations
    • Reduce risk profiles by identifying and addressing struggling clinical sites
    • Reduce costly site visits by shifting to reliance on offsite data monitoring
    • Maximize value and ROI from monitoring efforts
    • Eliminate unnecessary site visits, making every visit more valuable

    Data Sheet: Risk-Based Monitoring

    VIEW THE DATA SHEET

Regulatory Optimization Services

  •   Overview   

    Paragon has expertise crossing all areas of product development and post marketing activities: Regulatory, Clinical, Supply Chain and Manufacturing, Labeling, and Information Management. As a non-software client services organization, Paragon operates with complete non-bias in process development, system implementations, and vendor selection processes.

    Data Sheet: Regulatory Optimization Services

    VIEW THE DATA SHEET

  •   IDMP Services   

    Paragon has closely followed evolving IDMP regulations and timelines, and we have helped life sciences customers find, format, and assemble required IDMP data elements from structured and unstructured sources in their enterprise. We blend our up-to-date IDMP rule monitoring with our proven methods to rapidly assemble IDMP elements – from structured and unstructured data sources.

    We can help you start your IDMP program or help you focus and sharpen your existing IDMP efforts with these services:

    • Gap Analysis – identification of IDMP content across the organization, systems which house the content, and evaluation of steps necessary for compliance
    • IDMP Pilot Program Execution – If your organization is large (with over 30 products), we can help you estimate the total cost and level of effort that will be needed to reach IDMP Compliance. By populating actual IDMP elements for a sample of your products, we provide an accurate picture of your present IDMP readiness, and a clear estimate of exactly what you need to do to reach full IDMP compliance.
    • Standardization – co-development and application of standards to existing data, data cleansing, and interoperability evaluation/testing
    • Strategy – IDMP implementation strategy and approach, including Regulatory Information Management (RIM) and Master Data Management (MDM)

    White Paper: IDMP (Identification of Medicinal Products)

    DOWNLOAD THE WHITE PAPER

    Data Sheet: Identification of Medicinal Products

    VIEW THE DATA SHEET

  •   Regulatory Information Management   

    Our knowledge in Regulatory Information Management (RIM) and the challenges bringing together a complete regulatory architecture and RIM system help you successfully achieve an optimized RIM vision. We’ve developed a comprehensive, leading practice RIM framework to facilitate the development of a future state RIM strategy and roadmap for managing regulatory information across your organization.

    Our framework addresses the people, process, information, and technology aspects of the RIM vision, and ensures alignment among executive and business leaders. Our strategy practitioners leverage this framework to provide a comprehensive view of the current environment, a vision for the future based on leading practices tailored to your needs, and a roadmap for getting there.

    The roadmap provides you with a path forward to efficiently and effectively:

    • Manage global product registrations and manufacturing changes throughout the product life cycle
    • Manage health authority correspondence and commitments
    • Plan and manage regulatory submissions, labeling, and promotional materials
    • Manage pharmacovigilance and adverse events
    • Stay abreast of the latest regulatory intelligence

    Data Sheet: Regulatory Information Management

    VIEW THE DATA SHEET

  •   Regulatory Compliance   

    Paragon has a wide breadth of regulatory experience covering affairs, intelligence, operations, and compliance strategy. Our Regulatory Compliance Services augment your organization’s own internal capabilities to prepare for, execute, and address compliance-related observations and deficiencies.  Paragon is committed to alleviating this burden by helping you design, assess, and transform the processes, controls, and infrastructure needed to mitigate the wide variety of specific regulatory and compliance risks your organization faces.

    Our compliance consultants can help your organization with:

    • Regulatory Based Submissions – in compliance with the performance standards of U.S. Food & Drug Administration (FDA), or other regulatory agencies
    • Compliance Strategy – helping your organization to understand, compare, and contrast the regulations in each and every country of operation in order to develop the most effective strategy to maintaining compliance across the enterprise
    • Monitoring – continuously monitor regulatory changes, rapidly interpret, and understand the new requirements and their impact on your business
    • Inspections – provide regulatory input before and during inspections to minimize the risks of future non-compliance

    Infographic: Evolving Regulatory Standards

    VIEW THE INFOGRAPHIC

  • Paragon has expertise crossing all areas of product development and post marketing activities: Regulatory, Clinical, Supply Chain and Manufacturing, Labeling, and Information Management. As a non-software client services organization, Paragon operates with complete non-bias in process development, system implementations, and vendor selection processes.

    Data Sheet: Regulatory Optimization Services

    VIEW THE DATA SHEET

  • Paragon has closely followed evolving IDMP regulations and timelines, and we have helped life sciences customers find, format, and assemble required IDMP data elements from structured and unstructured sources in their enterprise. We blend our up-to-date IDMP rule monitoring with our proven methods to rapidly assemble IDMP elements – from structured and unstructured data sources.

    We can help you start your IDMP program or help you focus and sharpen your existing IDMP efforts with these services:

    • Gap Analysis – identification of IDMP content across the organization, systems which house the content, and evaluation of steps necessary for compliance
    • IDMP Pilot Program Execution – If your organization is large (with over 30 products), we can help you estimate the total cost and level of effort that will be needed to reach IDMP Compliance. By populating actual IDMP elements for a sample of your products, we provide an accurate picture of your present IDMP readiness, and a clear estimate of exactly what you need to do to reach full IDMP compliance.
    • Standardization – co-development and application of standards to existing data, data cleansing, and interoperability evaluation/testing
    • Strategy – IDMP implementation strategy and approach, including Regulatory Information Management (RIM) and Master Data Management (MDM)

    White Paper: IDMP (Identification of Medicinal Products)

    DOWNLOAD THE WHITE PAPER

    Data Sheet: Identification of Medicinal Products

    VIEW THE DATA SHEET

  • Our knowledge in Regulatory Information Management (RIM) and the challenges bringing together a complete regulatory architecture and RIM system help you successfully achieve an optimized RIM vision. We’ve developed a comprehensive, leading practice RIM framework to facilitate the development of a future state RIM strategy and roadmap for managing regulatory information across your organization.

    Our framework addresses the people, process, information, and technology aspects of the RIM vision, and ensures alignment among executive and business leaders. Our strategy practitioners leverage this framework to provide a comprehensive view of the current environment, a vision for the future based on leading practices tailored to your needs, and a roadmap for getting there.

    The roadmap provides you with a path forward to efficiently and effectively:

    • Manage global product registrations and manufacturing changes throughout the product life cycle
    • Manage health authority correspondence and commitments
    • Plan and manage regulatory submissions, labeling, and promotional materials
    • Manage pharmacovigilance and adverse events
    • Stay abreast of the latest regulatory intelligence

    Data Sheet: Regulatory Information Management

    VIEW THE DATA SHEET

  • Paragon has a wide breadth of regulatory experience covering affairs, intelligence, operations, and compliance strategy. Our Regulatory Compliance Services augment your organization’s own internal capabilities to prepare for, execute, and address compliance-related observations and deficiencies.  Paragon is committed to alleviating this burden by helping you design, assess, and transform the processes, controls, and infrastructure needed to mitigate the wide variety of specific regulatory and compliance risks your organization faces.

    Our compliance consultants can help your organization with:

    • Regulatory Based Submissions – in compliance with the performance standards of U.S. Food & Drug Administration (FDA), or other regulatory agencies
    • Compliance Strategy – helping your organization to understand, compare, and contrast the regulations in each and every country of operation in order to develop the most effective strategy to maintaining compliance across the enterprise
    • Monitoring – continuously monitor regulatory changes, rapidly interpret, and understand the new requirements and their impact on your business
    • Inspections – provide regulatory input before and during inspections to minimize the risks of future non-compliance

    Infographic: Evolving Regulatory Standards

    VIEW THE INFOGRAPHIC