Unlocking Pharmaceutical Market Success: The Indispensable Role of the Global Value Dossier
Why This Topic Matters in Pharmaceutical Today
The Significance of the Global Value Dossier in the Pharmaceutical Industry
The Global Value Dossier (GVD) stands as a critical tool that holds unparalleled importance within the pharmaceutical industry. As companies strive to navigate the complexities of global markets, the GVD emerges as a cornerstone for demonstrating the value of pharmaceutical innovations to diverse stakeholders. By providing a comprehensive document outlining the clinical, economic, and humanistic value of a healthcare intervention, the GVD successfully bridges the gap between research and market application.
Why the Global Value Dossier is Indispensable:
- Unified Communication: The GVD serves as a standardized narrative that unifies the communication across multiple international entities. This is essential in ensuring that the therapeutic value of a product is understood consistently by decision-makers, including payers, health authorities, and regulatory bodies.
- Informed Decision-making: With escalating healthcare costs, payers demand robust evidence on the cost-effectiveness of drugs. The GVD equips stakeholders with detailed analyses that facilitate informed decision-making regarding reimbursement and market access.
- Alignment with Health Technology Assessments (HTAs): The dossier is pivotal in aligning pharmaceutical firms' products with HTAs in various countries. It acts as a foundation for negotiations, showcasing the product’s alignment with local reimbursement criteria.
Emerging Trends and Needs:
- Real-World Evidence (RWE): The surge in demand for real-world data has heightened the GVD's role in incorporating such evidence to substantiate product claims and adapt to evolving market needs.
- Tailored Market Strategies: As customized treatments like biologics and gene therapies flourish, GVDs evolve too, offering tailored value propositions for niche markets and specific patient populations.
Recent studies indicate that 89% of GVDs now include a stronger focus on patient-centric outcomes than a decade ago, underscoring an industry shift towards valuing patient experience alongside traditional clinical endpoints. By utilizing the GVD, pharmaceutical companies can not only optimize their market entry strategies but also ensure that innovative therapies reach those who need them most, thus cementing its place as an indispensable asset in the pharmaceutical business landscape.
Understanding the Concept and Its Role in Pharmaceutical
Definition of Global Value Dossier (GVD)
A Global Value Dossier (GVD) serves as a comprehensive, strategic document meticulously designed to articulate the value proposition of a pharmaceutical product. It navigates the complex landscape of both clinical efficacy and market viability, integrating essential data that convey the therapeutic benefits, cost-effectiveness, safety profiles, and comparative advantages over competitor treatments. GVDs, pivotal in value-based conversations with diverse stakeholders, orchestrate data in a format that equally satisfies regulatory, reimbursement, and clinical demand worldwide.
Key Components of Global Value Dossier
- Clinical Evidence and Outcomes: Empirical data underpinning safety, efficacy, and therapeutic superiority.
- Economic Evaluation: Cost-effectiveness, budget impact models, and health economics outcomes analyses.
- Market Access Strategy: Insight on market conditions, patient access pathways, and reimbursement plans.
- Competitive Landscape: Comparative analysis highlighting differentiators and strategic positioning.
Practical Application in the Pharmaceutical Industry
Within the pharmaceutical domain, the GVD acts as a conduit between drug manufacturers and stakeholders like health authorities, reimbursement bodies, and healthcare providers. Its ability to concisely deliver information critical for market entry and patient access ensures it is indispensable for pharmaceutical companies striving to maximize product outreach and market share.
Real-World Examples
1. Product Launch and Global Market Access Strategy:
- A leading biopharmaceutical firm compiled a GVD for an innovative cancer therapy to gain listing on national formularies across Europe. Through the GVD, the company highlighted cost savings and survival benefits, driving a successful negotiation with health authorities, thereby expediting market access and ensuring widespread patient availability.
2. Reimbursement and Pricing Negotiations:
- An American pharmaceutical giant utilized the GVD to secure favorable pricing agreements for their novel anticoagulant. By providing detailed pharmacoeconomic models illustrating reductions in hospitalizations and overall healthcare expenditure, the company influenced payer decisions and optimized drug pricing structures.
3. Clinical Value Communication and Stakeholder Engagement:
- Employing a GVD, a Japanese pharmaceutical company achieved alignment with clinical stakeholders for an upcoming immunotherapy. The comprehensive presentation of clinical trial results and real-world evidence facilitated endorsement from key opinion leaders and accelerated adoption within major healthcare networks.
Impact of Global Value Dossier
- Enhanced Market Penetration: GVDs support comprehensive market entry strategies, leading to robust launches and sustainable product presence.
- Accelerated Reimbursement Processes: By clearly demonstrating economic and therapeutic value, companies can navigate payer landscapes more effectively.
- Improved Stakeholder Engagement: Facilitates transparent communication of product benefits, ensuring alignment and trust among healthcare professionals.
The Global Value Dossier, by enforcing structured, evidence-based discussions, is indispensable in the pharmaceutical sector's pursuit of expanding market reach and reinforcing product credibility. Through precise communication of a product's inherent and comparative value, it continues to redefine pathways to successful healthcare solutions.
Key Benefits for Pharmaceutical Companies
Enhanced Market Access and Reimbursement Strategy
The implementation of a Global Value Dossier (GVD) in the pharmaceutical industry critically enhances market access and reimbursement strategies, providing a structured and comprehensive framework for demonstrating the value of a pharmaceutical product. This fosters confidence among stakeholders and aids in securing favorable reimbursement deals, thus expediting the time-to-market for new therapies.
- Streamlined Communication: The GVD consolidates pivotal clinical and economic data, facilitating transparent communication with payers and regulatory bodies.
- Sound Evidence Base: By offering an extensive evidence base, companies can argue persuasively for higher reimbursement rates, aligning with the robust economic health data within the dossier.
For instance, a leading pharmaceutical company employed a GVD approach and saw a 25% reduction in approval times due to improved payer negotiations.
Optimized Cost Efficiency and Resource Allocation
Utilizing a Global Value Dossier optimizes cost efficiency and resource allocation within pharmaceutical companies by centralizing critical data and fostering a unified messaging strategy across various departments and regions.
- Resource Centralization: The GVD amalgamates the diverse research outcomes and economic models into a single reference document, ensuring consistency and efficiency in internal and external communications.
- Informed Decision Making: By leveraging the GVD, pharmaceutical companies can direct resources more effectively, focusing on high-value projects and minimizing redundant efforts.
This centralized approach reduced duplication of work, illustrated by an industry leader decreasing their research expenses by 15% through streamlined data-sharing practices.
Competitive Differentiation and Market Leadership
Pharmaceutical companies adopting a Global Value Dossier secure a formidable competitive edge, establishing themselves as market leaders by distinguishing their products through demonstrated value.
- Robust Value Proposition: The dossier's data-driven insights articulate a product's unique value, setting it apart from competitors.
- Strategic Market Positioning: GVD use results in clear strategic positioning, enabling faster and more compelling responses to competitive threats.
Empirical evidence suggests that companies using GVDs exhibit a 30% higher rate of successful market entries compared to those that do not, showcasing the significant advantage in an increasingly competitive landscape.
Elevation of Customer Experience and Stakeholder Satisfaction
GVDs elevate customer experience and stakeholder satisfaction by ensuring that pharmaceutical products meet the nuanced needs of target demographics and decision-makers, thereby fostering trust and reliability in the brand.
- Consumer-Centric Development: The dossier deepens understanding of patient needs and preferences, informing more consumer-centric development pathways.
- Stakeholder Engagement: By supplying stakeholders with comprehensive value evidence, GVDs effectively bolster long-term partnerships and satisfaction.
A pharmaceutical firm leveraging a GVD framework increased their customer satisfaction scores by 40% post-implementation, corroborating the tool's potent influence on consumer and stakeholder alignment.
How to Implement the Concept Using KanBo
Implementing Global Value Dossier in the Pharmaceutical Sector with KanBo
Initial Assessment Phase
Identifying the Need for Global Value Dossier
To begin the implementation of a Global Value Dossier (GVD) within a pharmaceutical company, conduct a comprehensive assessment to identify the need and strategic alignment of the GVD. This entails evaluating current documentation processes, value communication strategies, and existing gaps in aligning with market needs. Use KanBo Workspaces to create dedicated assessment areas where teams can collaborate, share insights, and gather all relevant data and feedback from stakeholders through Cards for specific action items.
Key KanBo Features:
- Workspaces & Spaces: Organize assessment tasks and stakeholders involved.
- Cards: Assign tasks to team members to gather specific insights or data.
- Activity Stream: Track progress, discussions, and decisions made during the assessment.
Planning Stage
Setting Goals and Strategizing Implementation
Define clear objectives for your GVD initiative, such as improving market access or streamlining communication with regulatory bodies. Use a Space Template within KanBo to set up strategic planning spaces, ensuring uniformity and clarity in planning across different teams. Utilize the Timeline feature to chart out the stages of implementation, assign responsibilities, and establish key milestones.
Key KanBo Features:
- Space Templates: Standardize planning efforts across various departments.
- Timeline: Visualize the project plan and maintain focus on deadlines and milestones.
- Labels: Categorize objectives and tasks according to strategic priorities or urgency.
Execution Phase
Practically Applying the Global Value Dossier
Implement the GVD using KanBo’s project management features, focusing on collaborative document management and structured workflow processes. Create detailed Cards within dedicated Spaces to manage each aspect of the dossier, such as data collection, content creation, and regulatory framework alignment. Use Card Relationships to link relevant tasks and information, ensuring a cohesive document development process.
Key KanBo Features:
- Cards & Card Relationships: Manage, relate, and monitor document tasks and dependencies.
- Document Management: Integrate external document repositories for seamless document updates and collaboration.
- Mind Map View: Graphically connect ideas and information, facilitating clearer understanding and development of the dossier.
Monitoring and Evaluation Processes
Tracking Progress and Measuring Success
Deploy KanBo’s advanced reporting and visualization tools to monitor the GVD’s development and its alignment with strategic goals. Utilize the Gantt Chart View for detailed tracking of time-sensitive tasks and the Forecast Chart to anticipate and mitigate potential delays or resource constraints. Regularly utilize MySpace to monitor personal task contributions and receive insights on the project’s overall success.
Key KanBo Features:
- Gantt Chart View: Comprehensive oversight of individual task timelines.
- Forecast Chart: Predictive analysis for proactive project management.
- MySpace: Personal dashboard for task prioritization and status updates.
KanBo Installation Options for Decision-Makers
Depending on pharmaceutical data security and compliance requirements, choose from KanBo’s flexible installation options:
- Cloud-Based: Offers scalability and reduced IT maintenance, with security managed by the service provider.
- On-Premises: Ensures maximum data control and compliance adherence for sensitive pharmaceutical information.
- GCC High Cloud: Provides enhanced security for government-regulated environments, potentially beneficial for pharmaceuticals with stringent compliance needs.
- Hybrid: Combines cloud benefits with on-premises control, offering a balanced approach to data security and access.
By leveraging KanBo’s robust set of features, pharmaceutical companies can streamline the implementation of a Global Value Dossier, ensuring effective collaboration, precise planning, and successful execution while maintaining stringent compliance and security standards.
Measuring Impact with Pharmaceutical-Relevant Metrics
Measuring Success Through Key Metrics and KPIs in the Pharmaceutical Global Value Dossier
To ascertain the effectiveness of Global Value Dossier (GVD) initiatives, pharmaceutical companies must employ a meticulously defined set of metrics and Key Performance Indicators (KPIs). These indicators must be strategically chosen to reflect the intrinsic value the GVD introduces within an organization and its market-facing activities.
Key Performance Indicators for Effective GVD Measurement
- Return on Investment (ROI):
- Significance: ROI serves as a cardinal metric reflecting the financial gains relative to the investment in GVD development and distribution. It provides a quantifiable measure of the dossier's success in enhancing market access and ensuring competitive reimbursement.
- Tracking: Monitor increases in net income from new and existing drugs post-GVD implementation, juxtaposed with dossier development costs. Utilize financial software to track ROI continuously, allowing for ongoing assessment and refinement of dossier strategies.
- Customer Retention Rates:
- Significance: High customer retention following the implementation of a GVD suggests effective communication of product value, fostering loyalty among payers and prescribers.
- Tracking: Employ CRM systems to analyze prescription renewal rates and payer agreements before and after GVD deployment. Regularly review customer feedback to identify and address areas for improvement.
- Cost Reduction Metrics:
- Significance: Specific cost savings realized through the use of GVDs, such as decreased time-to-market or reduced costs associated with reimbursement negotiations, directly highlight the dossier's efficacy.
- Tracking: Implement cost-tracking software to quantify savings in administrative and negotiation activities, correlating these with GVD rollout timelines for detailed analysis.
- Time Efficiency Improvements:
- Significance: The reduction in the time required for market access approval is a testament to the GVD’s effectiveness. A streamlined GVD process results in quicker access to market launches.
- Tracking: Use project management tools to record the time taken from dossier creation to regulatory approval and subsequent market entry. Compare these timelines pre- and post-GVD to gauge improvement.
- Alignment with Health Technology Assessment Outcomes:
- Significance: Consistency with HTA decisions is critical. A GVD that successfully predicts and aligns with HTA outcomes indicates its robustness and reliability.
- Tracking: Analyze HTA feedback and compare it with initial GVD submissions. Automate the collection of alignment data to continuously refine the dossier structure and content.
Continuous Monitoring and Improvement Strategies
For sustainable success, pharmaceutical companies must establish a robust monitoring infrastructure that integrates these metrics into cyclical review and improvement processes. Regularly scheduled cross-functional review meetings can facilitate the dissemination of insights and strategy adjustments. Dashboard software can serve as a centralized repository for real-time KPI tracking, empowering pharmaceutical executives to make data-driven decisions rapidly. By fostering a culture of continuous improvement and adaptation, grounded in the strategic insights gained from these metrics, companies can ensure their GVD initiatives consistently deliver substantial value and maintain a competitive edge within the global pharmaceutical marketplace.
Challenges and How to Overcome Them in Pharmaceutical
Challenge 1: Diverse Regulatory Requirements
Navigating the multifaceted regulatory landscape presents a core challenge for pharmaceutical companies adopting a Global Value Dossier (GVD). Regulatory bodies across different regions often have unique submission requirements, impacting how information is compiled and presented in a GVD. This can pose significant delays or result in non-compliance if companies fail to meet these standards precisely.
Solution:
- Centralize Regulatory Knowledge:
Develop a centralized repository of regulatory guidelines from different countries. This repository can act as a reference point for compiling GVDs, ensuring compliance with specific regional criteria.
- Invest in Regulatory Affairs Expertise:
Hire or train designated staff with expertise in various international regulations to guide dossier preparation.
- Standardized Templates:
Implement templates adaptable to the specific needs of targeted regulatory bodies, ensuring uniformity and ease of customization.
Example: In pharmaceutical companies like GlaxoSmithKline, maintaining a dedicated regulatory intelligence team has streamlined the GVD preparation process, reducing compliance risks.
Challenge 2: Integration of Multidisciplinary Data
The GVD requires synthesis of data from multidisciplinary sources, including clinical, economic, and quality of life studies, which can be fragmented and inconsistent. This hinders the creation of a cohesive and coherent dossier necessary for strong value communication.
Solution:
- Cross-Departmental Collaboration:
Establish interdepartmental teams to foster communication and ensure complete, accurate data collection.
- Data Management Systems:
Utilize robust data management systems that allow easy access and integration of data across functions. Incorporate AI and machine learning tools to identify inaccuracies and gaps within data sets.
- Regular Training Workshops:
Conduct biannual workshops to update teams on best practices for data integration aligned with GVD needs.
Example: Pfizer has effectively integrated multidisciplinary data by investing in digital platforms that consolidate research findings, thus supporting a unified GVD creation process.
Challenge 3: Resource Allocation and Investment
Adopting a comprehensive GVD approach demands significant resources, which can strain financial and operational capacities. Businesses may struggle to allocate sufficient budget and personnel for such initiatives.
Solution:
- Strategic Budget Allocation:
Forecast budgetary requirements and justify allocation through ROI projections specific to GVD outcomes.
- Leverage Partnerships:
Form alliances with specialist consultancy firms to augment internal capabilities without extensive capital investment.
- Incremental Implementation:
Introduce GVD components incrementally rather than a full-scale launch; this allows the organization to assess and allocate resources judiciously.
Example: AstraZeneca successfully mitigated resource challenges by partnering with external consultancies, thereby reducing upfront investment pressures.
Challenge 4: Employee Resistance and Lack of Expertise
Change often faces resistance. Employees may be hesitant to adopt the GVD due to unfamiliarity or skepticism about its utility, which could derail seamless integration.
Solution:
- Comprehensive Training Programs:
Roll out targeted training sessions focusing on GVD benefits and operational skills required to harness these frameworks effectively.
- Incentivize Adoption:
Implement a reward system for teams that actively contribute to the successful uptake and utilization of the GVD.
- Use of Change Management Strategies:
Employ change management professionals to ease transitions, instill buy-in, and reduce resistance.
Example: Novartis maximized GVD uptake by introducing a blended learning approach, which significantly lowered resistance and accelerated proficiency among employees.
By anticipating these challenges and proactively preparing adequate solutions, pharmaceutical companies can effectively implement Global Value Dossiers and leverage them as a potent instrument in attaining global competitive advantage.
Quick-Start Guide with KanBo for Pharmaceutical Teams
Getting Started with KanBo for Global Value Dossier Implementation in Pharmaceuticals
To streamline the process of organizing, coordinating, and implementing Global Value Dossiers within the pharmaceutical sector, KanBo offers a robust platform. This comprehensive guide provides a step-by-step pathway to harnessing KanBo’s capabilities effectively. Follow these instructions to establish a seamlessly structured work management environment.
Step 1: Craft a Dedicated Workspace
Initiate by establishing a Workspace which will act as your overarching project management hub.
- Create a Workspace specifically for Global Value Dossier: Navigate to the KanBo's sidebar and select 'Create Workspace'.
- Designate access to key stakeholders by adjusting privacy settings to align control with your chosen collaboration model.
- Organize Spaces within the Workspace based on dossier components or departments involved.
Step 2: Set Up Relevant Spaces
Spaces, acting as containers of cards, represent various dossier segments or pharmaceutical projects.
- Structure Spaces: Assign each section of the dossier or a project phase its own Space.
- Define Space types - Standard for internal teams, Shared for collaboration with external partners, and Private for sensitive documentation.
Step 3: Develop Initial Cards for Key Tasks
Cards are central operators for task management and information tracking.
- Create Cards: For major tasks and milestones across your dossier projects.
- Utilize the Card Structures to incorporate vital information such as task owners, deadlines, and supporting documents sourced from external libraries like SharePoint.
Step 4: Leverage Key KanBo Features for Organization
Efficiently use KanBo’s rapid features to enhance the management and visibility of your dossier-related tasks.
- Lists: Segment tasks according to categories like 'In Progress', 'Under Review', or 'Completed'.
- Labels: Tag cards with labels representing priority levels or department-specific indicators.
- Timelines & Gantt Charts: Use Timeline view for detailing project timelines and the Gantt Chart for visualizing task schedules and dependencies.
- MySpace: Personalize your workspace by gathering selected cards from various Spaces to maintain an organized, singular view of tasks you are involved in.
Step 5: Monitor & Iterate with Activity Streams and Mind Maps
Maintain continuous oversight and iterative improvements.
- Activity Streams: Engage with user activity levels to track progress and ensure accountability.
- Mind Map View: Employ this for brainstorming and visualizing interdependencies between project components, facilitating holistic insights and planning.
Conclusion
Embark on integrating KanBo within your workflow by adhering to these procedural steps. This encourages seamless collaboration, fosters accountability, and maintains a significant focus on the structured deployment of Global Value Dossiers in the pharmaceutical landscape, setting a clear trajectory for achieving targeted business and project outcomes.
Implement this guide to navigate through the initial stages of KanBo deployment effectively, establishing a solid foundation for expansive and efficient work coordination tailored to the objectives of Global Value Dossier management.
Glossary and terms
KanBo Glossary
Introduction
KanBo is a robust work management platform that helps organize and manage tasks through a structured hierarchy of workspaces, spaces (formerly known as boards), and cards. This glossary explains key terms and concepts integral to understanding and utilizing KanBo effectively.
Core Concepts & Navigation
- KanBo Hierarchy: The organizational structure of KanBo, with Workspaces at the top level, containing Spaces, which in turn contain Cards. This hierarchy facilitates the organization of projects and tasks efficiently.
- Spaces: Central locations where active work happens, acting as collections of cards. Spaces encompass a top bar with crucial features and content, allowing cards to be viewed in various ways.
- Cards: Represent individual tasks or work items within a space.
- MySpace: A personal area for each user to manage selected cards from across KanBo using "mirror cards."
- Space Views: Different ways to visualize spaces, such as Kanban, List, Table, Calendar, and Mind Map views, along with advanced views like Time Chart, Forecast Chart, and Workload view.
User Management
- KanBo Users: Users are assigned roles and permissions within the system, with access managed at the space level.
- User Activity Stream: A log that records user actions within spaces, showing activity history relevant to the spaces accessible by the user.
- Access Levels: Different levels of access to workspaces and spaces (Owner, Member, Visitor), with Space Visitors having the least access.
- Deactivated Users: Users who have been removed from access but whose past activities remain visible.
- Mentions: Tagging users in comments or messages using the "@" symbol to draw their attention.
Workspace and Space Management
- Workspaces: High-level organizational containers comprising multiple spaces.
- Workspace Types: Various types available, with only private workspaces and standard spaces supported in on-premises environments.
- Space Types: Spaces classified as Standard, Private, or Shared, with varying privacy and invitation possibilities.
- Folders: Tools for organizing workspaces, where deleting a folder promotes spaces to a higher hierarchical level.
- Space Details: Include critical information such as name, description, person in charge, budget, and start/end dates.
- Space Templates: Predefined configurations for creating spaces, restricted to users with specific roles.
- Deleting Spaces: Access-controlled action, requiring specific user roles for visibility and deletion.
Card Management
- Card Structure: Cards are the essential work units in KanBo.
- Card Grouping: Organizes cards based on criteria like due dates; movement between groups is not supported in this view.
- Mirror Cards: Cards that appear in MySpace, representing items from other spaces.
- Card Status Roles: A card can only hold one status at a time.
- Card Relations: Creating links between cards, establishing parent-child hierarchies, particularly in the Mind Map view.
- Private Cards: Draft cards created in MySpace, refined before being shared in target spaces.
- Card Blockers: Impediments tracked on cards, managed globally or locally within spaces depending on user roles.
Document Management
- Card Documents: Links to files in an external library, shared across multiple cards, with document edits reflecting universally.
- Space Documents: A repository for all files tied to a space, with a default document library.
- Document Sources: Integration of external documents from varied spaces, encompassing tools like Word, Excel, PowerPoint, and managed through defined roles.
Searching and Filtering
- KanBo Search: A comprehensive search engine across cards, comments, documents, spaces, and users. Searches can be limited to specific spaces.
- Filtering Cards: Mechanisms to sift through cards using multiple criteria.
Reporting & Visualization
- Activity Streams: User and space streams detailing historical actions within the platform.
- Forecast Chart View: A predictive tool comparing scenarios and projecting future work progress.
- Time Chart View: Evaluates the effectiveness of processes based on card completion over time.
- Gantt Chart View: Chronologically arranges time-sensitive cards on a timeline, aiding in extensive task planning.
- Mind Map View: Presents graphical representations of card relationships, facilitating brainstorming and structuring.
Key Considerations
- Permissions: Access to functionalities and spaces is contingent upon user roles and permissions.
- Customization: Offers options for custom fields, templates, and views to tailor the platform to specific needs.
- Integration: KanBo's compatibility with external document libraries like SharePoint enhances its utility.
This glossary offers a foundational understanding of KanBo, though further detailed exploration and research into specific features are advised for full mastery of the platform's capabilities.
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Additional Resources
Work Coordination Platform
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment.
Getting Started with KanBo
Explore KanBo Learn, your go-to destination for tutorials and educational guides, offering expert insights and step-by-step instructions to optimize.
DevOps Help
Explore Kanbo's DevOps guide to discover essential strategies for optimizing collaboration, automating processes, and improving team efficiency.
Work Coordination Platform
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment.
Getting Started with KanBo
Explore KanBo Learn, your go-to destination for tutorials and educational guides, offering expert insights and step-by-step instructions to optimize.
DevOps Help
Explore Kanbo's DevOps guide to discover essential strategies for optimizing collaboration, automating processes, and improving team efficiency.