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Empowering Clinical Trial Decisions with Data-Driven Decision Management (DDDM)

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Empowering Clinical Trial Decisions with Data-Driven Decision Management (DDDM)

Transform clinical trial outcomes with data-driven insights: integrate diverse data sources, implement advanced analytics, and uncover key performance trends. Optimize resource allocation, enhance recruitment strategies, and boost success rates with actionable intelligence powered by expert solutions.

Why read this whitepaper?

Practical insights: Real-world success stories of companies optimizing clinical data collection and management for a data- driven approach.


Best practices: Proven practices which can help maintain data governance and data quality.


Data-driven impact: Understanding data-driven decision-making for improved efficiency, reduced risks, and accelerated timelines in clinical trials.

Empowering clinical trials with data-driven decisions

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How technology can fill gaps within resource management for overall PPM success

How technology can fill gaps within resource management for overall PPM success

Resource management for PPM success Resource management is often the most overlooked aspect of R&D portfolio and project management. Despite its crucial role in ensuring project success, many organizations focus predominantly on project selection and prioritization, but neglect or defer addressing the complexities of allocating limited resources across multiple projects. This can lead to bottlenecks, delays and inefficiencies that not only undermine portfolio performance but also significantly impact time-to-market for new therapies. Research highlights that effective resource management and allocation can improve project success rates by up to 40%, underscoring their critical role in project portfolio success.McKinsey's report on strategic financial planning emphasizes that organizations which align their strategic financial plans with their resource allocation processes tend to outperform their peers. Companies that reallocate resources across business units within the year are significantly more likely to achieve superior revenue growth and return on capital In this blog, we will delve into how technical advancements can help resource and project managers have deeper visibility into named resource forecast, allocation, capacity and more. Leveraging technology for efficient resource management in life sciences Effective resource management is crucial, especially considering that large pharmaceutical companies typically manage hundreds of cross-functional and functional projects simultaneously across different therapeutic areas. With R&D spending in the industry averaging 15-20% of revenue, efficient allocation of both financial and human resources is key to portfolio success. Technology plays a vital role in effectively implementing any effective resource management. Life sciences organizations have an established ecosystem of tools and platforms which help to efficiently manage resources across all projects and portfolios. However, decisions on resource management capabilities are made through the lens of the enterprise, and typically do not provide the precision and granularity needed in the functional lines. In addition, data disparity and silos can still exist due to gaps in the tools in terms of visibility into named resource allocation, a clear idea on all auxiliary tasks assigned to the resources, etc. This can lead to insufficient visibility into resource allocation, task management, and coordination across teams. Introducing Alloc8With vast experience in PPM resource management for the life sciences, i2e Consulting developed Alloc8. It is a dedicated resource management tool that seamlessly integrates with your existing PPM ecosystem and focuses specifically on optimizing the use of human resources. Alloc8 is a unique tool which complements and extends existing enterprise tools by giving complete visibility of resource forecasts and allocation to line leads, department heads and product teams that require granular resource management data. It integrates resource data (required to make informed resource allocation) from various systems such as PPM tool (project schedules, resource needs and forecasts at the role level) HR system (employee skills, and name allocations), and Full Time Equivalents (FTEs). Alloc8 then extends visibility into named resource forecasts, allocation, and capacity. With intuitive features like task allocation, real-time progress tracking, and efficient coordination, Alloc8 empowers teams to optimize resource utilization, and enhance project efficiency. Let’s go deeper into how Alloc8 can help life sciences organizations take data-driven decisions when it comes to resource allocation. Features Complete view: The tool integrates and extends information from different sources and offers a comprehensive view of the number of resources, their project schedules, forecasts, full-time equivalents, and HR systems. Spreadsheets are replaced with the compiled data, offering visibility into the skill sets and resource capacity.Automated workflow and optimization: Project managers can manage workloads effectively by utilizing the resources based on their availability and skillset. The advanced automated resource requisition fosters a shared model, thereby reducing internal conflicts and avoiding under- and over-allocation. Improved alerting and issue management: Alloc8 shares alerts and flags, proactively surfacing potential areas of concern. If desired, it can automatically takes meetings-related information from Outlook to streamline the collection of time spent/planned on project related meetings to enhance the identification of capacity constraints.Tracking and interactive visuals: Alloc8 provides detailed reports, interactive visuals, and real-time tracking that enables necessary changes as per the project’s progress. This keeps the project’s stakeholders informed and monitors the workflow as per the demands.Dashboards: The tool displays the forecasted availability of the resources for multiple tasks that lets the managers identify gaps and bridge them to minimize risks. Additionally, it facilitates governance and lets the managers devise mitigation strategies. For more details, check out Alloc8Now that we understand how technology can contribute to improving the efficiency of resource management, let’s see what business outcomes organizations can reap from a streamlined, and visible resource management process. Improves productivity One major advantage of efficient resource allocation is the boost in productivity it brings to an organization. With proper distribution of resources, organizations make sure that every team or project gets the right tools, time, and support that is required to achieve the best outcomes. It also ensures that employees aren't wasting time looking manually for resources or waiting for approvals; instead, they can focus on their main tasks and duties. Furthermore, resource allocation highlights bottlenecks or overburdened areas, allowing for timely corrections.A well-implemented resource allocation strategy significantly enhances productivity and streamlines operations, resulting in greater efficiency and better outcomes for the whole organization. 2. Boosts decision-making Efficient resource allocation provides resource and project managers with a clear understanding of the available resources and their distribution. This transparency allows for informed choices based on accurate data. Strategic resource allocation helps optimize efficiency, productivity, and overall success. With a well-structured plan and efficient decision-making, businesses can achieve their goals more effectively and boost profitability. 3. Enhances financial performance Smart resource allocation can significantly improve a company's financial performance. By distributing resources wisely, organizations can maximize productivity and minimize waste and unnecessary expenses. Proper allocation ensures every department or project receives the support and funding needed to meet its goals efficiently. This leads to smoother operations, better efficiency, and higher profitability. Additionally, it helps identify overused or underused resources, allowing for redirection to areas where they are needed most. Refining resource allocation strategies enhances financial performance and drives sustainable growth. Resource management in life sciences management is crucial to support complex, multi-disciplinary and long duration projects. Life sciences organizations are on a continuous journey to make their processes efficient and automated. Tools like Alloc8 would seamlessly integrate into your existing PPM systems and fill any gaps.

Project Structures: Overview and establishing with Planview, Planisware, and Project Online

Project Structures: Overview and establishing with Planview, Planisware, and Project Online

Project Structures: Overview and establishing with Planview, Planisware, and Project OnlineFrom a pharmaceutical R&D context, project structures can be seen as a reliable process to organize, track, and deliver the tasks while keeping the stakeholders informed. If you don’t have a well-planned project structure: Portfolio decisions usually suffer from low visibilityTeams start losing alignmentMissing critical deadlines become normal With a strong project structure, key decision-makers can: Have a clear view throughout the entire pipeline,Easily prioritize high-value portfolio assets Manage risks more efficiently Project portfolio management tools like Planisware, MS Project Online, and Planview help establish organized structures that accelerate pharma projects, ensure compliance and success. That said, let’s dive into what project structures mean in pharmaceutical context, and how these tools help establish them seamlessly. Types of project structures in pharmaceutical R&DSelecting the right structure is your first step to ensure on-time project delivery with the right resources, without bleeding budgets. Here are three types of project structures to consider: 1. Functional structure As the name suggests, functional structure involves grouping all teams as per specialized functions – be it clinical, manufacturing, regulatory etc. In this model, the departmental head usually manages the team members, while coordinating the projects within functional silos.Functional structures are best for:Small-scale pharma companiesLimited cross-functional project needsWhat to look out for?On the flipside, these models are also known to create communication gaps and slow down decision-making in accelerated R&D settings. 2. Projectized structure In this model, the project manager has 100% authority over the research team and key resources, unlike the former. The PMOs assign their teams to specific projects, often outside their everyday functional roles.Projectized structures are best for:Large-scale pharmaceutical project management needstime-sensitive, high-priority, high flexibility research initiatives What to look out for?Unfortunately, this model can also cause resource duplication and higher costs, particularly when multiple projects are running at the same time. 3. Matrix structure (Best suited for Pharma)Last, but most importantly, the matrix structure brings the best of both functional and projectized structures under one umbrella. Here, teams report to both functional and project managers. This way, resources can be shared across different projects without compromising on functional supervision.Matrix structures are best for:Mid-to-large organizations juggling between numerous programsHigh operational continuity & innovation-led settingsWhat to look out for?Despite being the most common project structure in pharma R&D, it calls for strong communication and higher role clarity, to avoid conflicts or confusion. How to establish Pharma-specific structures using Planisware, Project Online and Planview?Designing and implementing project structures that suit the complex requirements of pharmaceutical R&D become easier with PPM tools. Users can configure project hierarchies, governance models, allocate resources efficiently and support decision-making at every phase. Here are your options and steps to do it:Tool #1: PlanviewFirst on our list, Planview is a major contender in terms of portfolio management and resource optimization. With a little upfront tailoring, its project templates can align well with pharma workflows.How to set up a project structure in Planview?Configure project types: label templates (for example, “Phase I asset”, “Platform”)Define swimlanes as per function (clinical, regulatory, manufacturing)Set up a clear stage-gate workflow in roadmap view with well-defined gatesAttach gate checklists and deliverables to each stageEnable demand/capacity views for cross-functional resource alignment Tool #2: PlaniswareThe Planisware project management tool is purpose-built for life sciences projects, and mirrors pharma R&D workflows like none other in this list. For example, it embeds stage gate logic at every level. The platform natively supports clinical/CMC deliverables, molecule hierarchies, as well as regulatory milestones. Here, teams can easily set up projects that map exactly to asset phases, while having total control over gates and finances.How to set up a project structure in Planisware?Create a project template with WBS (discovery, preclinical, phase 1/2/3)Embed gates after every single phase, linking back to the decision criteria and business case scorecardsAdd key deliverables (for example: IND, CMC dossiers, clinical trial authorizations)Link back the financial/resource modules to WBS for seamless budget/version trackingRoll up to portfolio to maintain proper visibility across molecules and indications Tool #3: Project OnlineLastly, Project Online is a great choice for schedule-level planning; it’s not entirely built around pharmaceutical project management structures in focus. Here, teams need to build everything from ground up. The good part, however? Integrating with Power BI, Teams, and Power Automate.How to set up a project structure in Project Online?Start by designing your custom project template Define tasks for regulatory deliverables and project milestonesTrigger notifications at gate milestones by integrating Power Automate Integrate Power BI to access customized dashboards aligned to R&D phases’ progressManage resources via PWA to assign functional roles How to choose the right tool for your project structure needs?More than chasing latest features, choose project portfolio management tools that fit your team’s needs the best. This means judging the tool by how well it aligns with your project structure, people, and strategic goals. Choose Planisware if you would:Manage a mid-to-large pharma/biotech firm with a complex R&D asset portfolioRequire built-in stage-gate models, modifiable for drug development lifecyclesNeed strong portfolio governance & what-if scenario planning at scaleUse Project Online if you would:Require a quick, at-budget tool for basic-level project scheduling/ trackingFocus on daily task management, instead of strong portfolio governanceNeed hassle-free, end-to-end automation integration (Teams, Power BI, Outlook) Go for Planview if you would:Be transitioning from project-level to portfolio-level strategy while scaling upWant to have strong resource demand vs. capacity modelling Need visualized roadmaps, high financial visibility, cross-functional planning etc. Key takeaways at a glanceProject structure informs smart portfolio decisions, points out risks early and surfaces resource conflicts Matrix project structure is the best-suited for pharma/biotech teams, as it comes with a mix of agility, governance, and resource efficiencyMore features don’t ensure success; choose your tool that best fits your team’s maturity level, complexity of portfolio assets, and other key indicators.Planisware project management tool is best for enterprise players with deep pipelines; Project Online suits mid-sized teams focused on scheduling; Planview is the go-to option for strategy-driven PMOsNeed help getting started? Let’s talk about how we can help. i2e Consulting brings 15+ years of PPM expertise. We’ve partnered with leading pharma organizations to establish fit-for-purpose project structures that drive clarity, speed, and smarter portfolio decisions. Connect with us – let’s build a project structure that accelerates your portfolio growth.

PPM tools and Power BI: Smarter time reporting for precise decisions

PPM tools and Power BI: Smarter time reporting for precise decisions

PPM tools and Power BI: Smarter time reporting for precise decisionsTime tracking in pharma PPM: A backgroundTime carding captures data that has several strategic and operational benefits. Data lying in the tool is of limited use, but if it can be extracted and visualized it provides crucial insights into resource allocation, capacity planning, compliance and audit readiness, project cost control are a few to name.In pharma PPM, time carding is typically done through structured systems integrated with project and resource management tools. Their goal is to capture time spent across drug development stages, from discovery to post-marketing. No matter how insightful the data is, it’s true value comes out when analyzed and visualized.In this blog we will elaborate how integrations and data visualizations can become a game changer in extracting insights from your time carding data.Time reporting in complex project portfoliosMany large pharma teams with multi-year R&D investments deployed project portfolio management tools that had out-of-the-box time tracking features enabling activity-based time entry directly tied to project phases and operational workflows.Some had built-in approval flows, role-based tracking mechanisms, and integration with cost control and forecasting modules. Other project portfolio management tools have configurable timesheets with mobile access, enabling users to log time across multiple projects and tasks seamlessly. But now time tracking is moving from an afterthought to a core function with better tool customization and data integration.Integrating your PPM tool with Power BI- unlocks a whole new level of functional ease and data visibility. And project teams are using it as a strategic lever to gather insight and vision. Here’s more.How can time tracking data be more visible with smarter reporting tools like Power BI?Power BI integration with PPM tools enables dynamic project time tracking, with data represented in interactive, real-time dataflows. These visuals help managers identify over and underutilized resources, improve forecasting accuracy, and quickly detect delays or scope mismatches.Image: Time carding reportingAutomated reporting saving time and presenting real-time reportsIf your time carding is exported to SharePoint and subsequently to Power BI it can directly connect and auto-refresh that data. This dynamic data integration helps feed data representation, thereby empowering decision-makers to take informed data–driven steps.With tools like Azure Data Factory, Power Query, or custom scripts, users extract and load data from PPM tools into Power BI. This automated data integration saves time in manually collating data and building dashboards. It also removed the dependencies of running reports at the stipulated time frame to access real-time data.Custom dashboards pull in real-time data, visualize effort distribution across portfolios, and even highlight resource bottlenecks. With proper Power BI expertise, organizations can build interactive and visually appealing dashboards suited for decision-making at all levels.Such precise, actionable dashboards that are not disconnected from real resource utilization help PMOs to draw meaningful insights about capacity, effort distribution, or project health.Other possibilities Integrating Power BI with PPM tools like Planisware PPM or Planview brings seamless data flow helping project managers gain real-time visibility into resource utilization, task progress, and effort distribution across activities, programs, and portfolios. Tools like Planisware’s BI Box enable time and resource data to be exported to external databases, which Power BI then visualizes through interactive charts, tables, and summaries.With Planisware PPM, organizations can align time tracking with cost centers and funding sources, making it possible to calculate cost-per-project or even cost-per-submission. When this is visualized through Power BI dashboards, leadership gains clear visibility into burn rates, delays, and productivity trends—leading to smarter investment and resourcing decisions.This integration also enhances project reporting by enabling predictive analytics and trend analysis, allowing leaders to forecast delays, identify resource bottlenecks, and optimize allocation decisions.Power BI’s filtering and drill-down capabilities allow teams to view effort and time spent in a business unit, vertical, or project, supporting strategic decision-making. Click to read "Use case for Planisware PPM and Power BI integration" Benefits of this integrated approachCentralized and auditable time tracking A unified system captures precise time entries across projects, ensuring compliance and traceability for regulatory audits.Granular visibility into resource effort Teams and managers gain detailed insights into individual and team-level contributions, improving transparency and performance tracking.Streamlined tracking for all resource types Both full-time and contract resources can log time efficiently, enabling consistent reporting across diverse workforce models.Proactive forecasting and planning Accurate time data supports better resource forecasting, helping managers plan proactively and adjust workloads in real time.Actionable reporting for leadership Integrated Power BI dashboards deliver intuitive, high-level reports, empowering leadership with clear, data-driven insights for decision-making.With all this, the pharma PPM teams stay up to date with data, remain compliant, manage costs better, optimize resources, and deliver faster, smarter decisions across the product lifecycle.Smarter time reporting: The Road AheadAs life sciences portfolios evolve, comprehensive project time visibility brings precision, perspective, and speed. Integrated PPM tools and project reporting tools like Power BI generate data for real-time, actionable insights. This helps in bringing efficiency into time reporting, reducing waste, and delays.At i2e, we specialize in tailoring scalable and smart project time reporting solutions integrated with Power BI for your nuanced pharma project needs. Help us build that custom time tracking solution for you – one that fits with your workflow and scales with your vision. Talk to our experts today. .casestudy-block{ height: 50px; } .casestudy-block h1{ margin-top: -15px; !important } .casestudy-block a{ text-decoration: none; !important } .casestudy-block span{ color: #fff; !important }