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    Business Case Development
    Business Case Development

    We evaluate the benefits and risks of virtualization to give you a clear picture of what it means to run your program with the patient at the forefront and foundational principles of a quality culture. We align on the desired point of arrival, short- and long-term goals and assumptions. We deliver to you a business case with a value proposition that can be presented to executive stakeholders for endorsement and alignment.

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    Data and Analytics Strategy
    Data and Analytics Strategy

    We work with you to align key stakeholders on the importance of harnessing and managing your data. We work with senior leadership to outline an enterprise end-to-end data strategy that includes establishing Master Data Management (MDM) governance and processes, data quality best practices, a digital endpoint strategy, stakeholder reporting governance and continuous improvement actions based on data insights.

    Our deliverables include:

    • MDM Strategy Development
    • Data Governance Framework (processes, communication channels, roles and responsibilities, accountabilities, and escalation)
    • Data Migration and Integration Plans
    • System and Report Inventory
    • Standards and Data Dictionary

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    Virtualization Design Sessions
    Virtualization Design Sessions

    We facilitate design sessions with key stakeholders to drive efficiency in trial design and increase the value to the patient, caregiver and site. These design sessions may be run at the company, portfolio, or protocol level depending on your goals.  Together we generate implementation scenarios including digital endpoint assessments, patient outcome measures, virtualization and decentralized trial options. We assess your current technology, process, and resources to determine which tools, skillsets, and third-party vendors are best suited for your implement solution. 

     

    Our deliverables include:

    • Executive Summary outlining the recommended options and impact assessment for virtualization
    • Implementation Plan across technology, process, and resourcing:
      • Prioritized Set of Activities and Timelines
      • Process and Document Recommendations
      • Resourcing Recommendations (internal and external)
      • Vendor Recommendations
      • Change Management & Training Strategies
      • Transition Plans

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    Virtualization Solutions Implementation
    Virtualization Solutions Implementation

    We partner with you to implement the technologies, processes, and resources necessary to create meaningful change for your organization. We follow a strategic change management methodology, incorporating program leadership, role alignment, training and communication plans, and process documents where needed. We leverage our pre-qualified vendor shortlist to optimize execution.  

     

    Our deliverables include:

    • Program Leadership & Governance
    • Change Management (Role Alignment, RACI, Workflows, Sustaining Governance)
    • Virtualization Implementation Playbook
    • Selected and Qualified Vendors
    • Training and Communication Plans encompassing the Sponsor, Site, and Patient Levels
    • Process Documents
    • Data Integration Plan includes alignment of master data standards (if applicable)
    • System Implementation including validation support, data migration, training, and hypercare
    • Study-Specific Implementation Planning

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    RBx Strategy and Risk Management
    RBx Strategy and Risk Management

    We work with you to define the right technology-enabled risk management processes, key risk (KRI), performance (KPI), and quality indicators (KQI), and tools that enable risk-based approaches across the company, program, and study levels. These processes allow for earlier detection and mitigation of risks, proactive decision making, and cost-saving operational efficiencies. 

     

    At the study level, we perform a risk assessment with your key stakeholders and vendors to identify the critical risks, thresholds, and mitigations for the new virtual options using an efficient, pre-configured risk assessment & categorization tool (RACT). We outline the risk management strategy and clear risk triage and communication processes in an integrated quality and risk management plan (IQRMP) and update functional plans as needed. We develop a robust vendor oversight plan to enable effective and efficient vendor management.

     

    Our deliverables include:

    • Integrated Quality and Risk Management Plan (IQRMP)
    • Risk Assessment and Categorization Tool (RACT) alignment across all vendors and stakeholders
    • Key Risk Indicators (KRI) Library development and customization per study
    • Comprehensive Vendor Oversight Plan, including alignment on established Key Performance Indicators (KPIs/KRIs/KQIs)

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    Operational Health Assessments
    Operational Health Assessments

    We work with you to turn your data into insights that drive action. Using customized risk and data management strategies, we tailor your reporting needs to monitor key indicators of the operational health of your study. We recognize that there are multiple data consumers that require different levels of information and will provide a suite of automated reports and/or dashboards that include industry standard metrics and benchmarks for performance such as:

     

    • Portfolio-Level Senior Leadership Reporting (high-level operational, quality and financial health via established KPIs, KQIs and KRIs)
    • Program-Level Management Reports
    • Study-Level Management Reports
    • Investigator/Site-Level Reporting (comparing individual site metrics to study medians)
    • Patient-Level Reporting (providing visibility into collected health information)

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    Virtual Study Management & Execution
    Virtual Study Management & Execution

    We provide compliant, flexible virtual study management oversight, resources, and training to fit your trial needs.  We bring extensive third-party vendor selection and management experience as well as a breadth of regulatory, quality, and clinical expertise to help you identify the right vendor match, deliver studies faster than traditional CROs, and provide the oversight required to obtain high quality study results. We provide comprehensive training at the sponsor, vendor, site, and patient-levels to ensure optimal study success.