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.
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.
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Connecting HR, PMO and functional lines for effective resource management and talent retention
Resource management in pharma project teams: A brief backgroundIn life sciences organizations the need for faster time-to-market for drugs is critical with precision, timelines, and compliance as non-negotiable must-haves. Prolonged project timelines and complex divisional inter-dependencies emphasize managing resources optimally to enable a faster and smoother drug development lifecycle.Managing resources is not a single department job, there requires a continuous collaboration between functional lines, HR and the PMO to proactively respond to outsourcing/ in-house talent acquisition, FTE vs. Contractors. This partnership between functional lines, HR, and project resource management also identifies key positions with a complete clarity of roles and assignments leading to improved relationships with managers with colleagues seeing a clear connection between work and organizational goals. In this blog, we explore the impact of cross functional collaboration, how technology can help achieve system integrations, and transparency across the three divisions. Impact of Cross-functional collaboration: leveraging HR, functional lines, and the PMOEffective resource management collaboration is one where HR, functional lines and the Project Management Office (PMO), directly influence the success and efficiency of drug development and other scientific projects. The PMO roles & responsibilities in conjunction with functional lines ensuring whether human talent, equipment, facilities, budget and time are allocated optimally across complex and concurrent projects. In high-stakes environments where timelines are tight and compliance critical, planning foresight, cross-divisional teamwork, and shared resource management are essential to avoid costly delays and failed outcomes. Role of PMOThe PMO whether centralized or embedded Ensures the right skilled professionals are available when and where they are needed most.Monitors resource utilization to prevent overallocation or underuse.Collaborates closely with operations functions ensuring critical assets like lab manufacturing equipment or testing facilities are used efficiently.Uses forecasting tools and data analysis with PPM to anticipate resource needs, enabling proactive adjustments.For successful project delivery, the PMO also focuses on process and governance. With digital advances the ability to connect central PMO plans live to functional lines resource management is now a reality. This has allowed the PMO to evolve into a strategic function that not only oversees project resource management but also plays a central role in managing human capital across the organization. Role of HRHR is a key partner enabling functional lines deliver projects to avert resource onboarding delaysAligns talent supply with project demands based on skills, availability, and timelines.Minimizes turnover in critical roles through engagement and career planning.Upskills employees to meet technical and regulatory requirements.Recruiting specialized resources to support evolving R&D needs.Key non-personal data, skill set, grade information, training status, can be siloed in HR data systems with limited access for resource management needs. The PMO, along with the functional lines can combine this information to track engagement levels ensuring the right talent is assigned to the right teams. Role of functional lines The centralized or functional lines offer resource allocation clarity on physical resources, budgets, execution timelines and how these align with project plans. Allocates skilled resources to projects based on expertise and availabilityBalances project and functional priorities to avoid resource conflictsMonitors performance and development of team members across assignmentsProvides technical oversight to ensure quality and alignment with scientific goalsSupports resource forecasting through input on capacity and skill gapsEnables knowledge transfer across projects to maximize efficiency and learningFunctional lines also focus on lab space, production equipment, materials, and scheduling, etc. If the PMO is planning a clinical trial and needs lab time or manufacturing resources, Ops ensure those are available when needed. If a drug development project is moving into the manufacturing phase, functional lines work with the PMO to block out production lines and coordinate supply deliveries, while functional lines ensure the right technicians are trained and ready.The PMO acts as the central connector, pulling together people and information from different departments so everyone is on the same page.HR, PMO, and the functional lines communicating closely together support long-term talent development through targeted upskilling, mentoring, and coaching programs aligned with project demands. Decisions on how to address resource gaps may involve re-training or bringing in contract staff early if there’s a skills gap by responding to functional lines and PMO requests. This kind of advanced workforce planning in conjunction with HR makes sure the team is ready before the project hits full speed.However, data visibility gaps, and lack a single source of truth may cause roadblocks in creating the much-needed synergy between PMO, HR and functional line managers.When certain data from key technology systems is integrated, data can be seamlessly flown from various departments, want to learn how technology can break data silos and promote seamless collaboration between HR, PMO and functional Lines? Read on. How custom solutions enable resource management in a cross-functional collaborative way? Many life sciences companies are using enterprise level PPM tools for effective resource management and collaboration between departments, however, due to expensive licensing costs, the functional line managers may not have the visibility of into the broad level project plans within the tool. There is also poor visibility for essential non-portfolio projects visibility that is tracked outside the PPM tool.This is where a resource management framework can be a game changer. It is a flexible framework which seamlessly integrates with your existing PPM and HR systems to provide a comprehensive view of the resources and forecasting plans down to the functional manager level.This can serve as a digital trigger for identifying training and knowledge gaps as soon as named resources are assigned to forecast work. Using sophisticated AI, it suggests the right training and connects people to important internal resources—making sure everyone, from lab staff to leadership, stays aligned. It's also a valuable partner across the organization, supporting PPM for workforce colleague well-being and talent retention by giving better visibility into how talent is used, balancing workloads, and encouraging a strong, high-performing project culture. Plus, it works smoothly with your current PPM tools without getting in the way of your daily workFigure - Custom resource management differentiatorsSingle source of truthIt helps untangle the resource allocation complexity by providing a unified platform where everyone, from PMs to HR business partners to Functional Leads, can access and work with real-time data. This single source of truth eliminates confusion around who’s assigned to what, what skills are available, and where gaps exist, allowing teams to focus on their own role while staying aligned with others. Figure - Project overviewCross-functional data integrationOne of the biggest pain points in shared resource management and cross-functional collaboration is the disconnect between resource forecasting and the availability of resources in reality. The custom resource management framework bridges this gap and integrates existing project planning and PPM system benefits with data from HR systems, time tracking platforms and operations teams.When the PMO builds a forecast, for example an upcoming clinical development plan, they can see if the needed resource – a pharmacovigilance expert or a clinical data manager is available or not. In case there is a shortfall, functional lines can be alerted early with HR support to begin proactive hiring and training, redistributing resources. With data analytics looking at the trends of demand (forecast) vs capacity vs named allocation an enriched data set is available to inform long-term workforce development, new business models and real-time synchronization between individual teams to prevents last-minute scrambles and delays.Figure - Shared resource management dataOwnership of tasksIn most life science organizations, the PMO is responsible for coordinating and forecasting project needs, HR manages hiring, onboarding, and training frameworks, and functional line managers handle deployment and resource usage. Custom resource framework supports all by clearly defined ownership of tasks across functions, departments, teams, groups, down to named individuals providing ultimate flexibility to manage your workforce. These boundaries are supported by structured workflows within the platform, which ensures each team knows what they’re accountable for. This removes friction, eliminates duplication of efforts, and builds trust between divisions and teams. Figure - Task overviews360-degree resource visibilityThe custom resource management framework supports collaboration by offering personalized dashboards and reports for each department, making it suitable for successful project resource management. Fully customizable to your organization construct and operations model, HR can monitor attrition trends, training completion rates, and skill gaps. The PMO can view project-wise utilization and forecast accuracy. Operations can track functional capacity and site-specific allocation. This tailored insight empowers teams to make informed decisions and work in harmony toward common goals. Figure - Complete resource visibilityAutomated resource updates and alertsAnother strength of custom resource management framework is its ability to automate alerts and updates. When a resource is reassigned, needs training, or has a scheduling conflict, custom resource management framework notifies the right people instantly. This level of automation reduces manual tracking and ensures that changes are communicated across all teams without delay.Figure - Automated alerts for resourcesSeamless integration with larger tech stackThe custom resource management framework fits into your existing tech landscape. This differentiates it from other purpose-built frameworks. Whether the organization uses Workday for HR, MS Project or Planisware for PPM, or custom tools for time-tracking expertise, assuming data links are pre-established, this custom resource management framework integrates seamlessly without much effort helping you stay ahead of competition. As a result, there's no need for disruptive software changes, which makes adoption smoother and collaboration easier across functions. ConclusionIn PPM for workforce management, custom resource framework brings clarity, accuracy, and confidence to decision-making. It eliminates bottlenecks, prevents underutilization, and ensures cross-functional planning is based on real-time data. By enhancing visibility and transparency, custom resource management framework directly empowers PMO roles and responsibilities and helps align resources, manage capacity, and drive portfolio execution. It enables functional teams to collaborate effectively, building trust across the organization.Having supported life sciences companies for over 15 years, at i2e, we’ve seen firsthand that as portfolio scale and complexity increases, tools like Alloc8 are no longer “nice-to-have”, but are business-critical digital solutions. In today's dynamic fast paced data-driven world where work processes are rapidly evolving through ML / AL, can you afford to not be conducting named allocation? The answer is a resounding no. With the help of these business-critical digital solutions, you streamline processes, aid communication and hence accelerate product delivery, that is valuable in the longer term. This, in turn, impacts talent growth and retention gained through the visibility of resourcing decision making.
Project Online and Power BI- A Dynamic Duo for Making Reports That Matter
Is making reports taking up all your time? Or Are you still wondering the answers to questions such as ‘what is the project’s progress? Or ‘how much will this project cost the company after two years?’ then your business needs a digital makeover. Companies need applications that can quickly analyze huge data sets and come up with trends that can help in decision-making. This is where Project Online and Power BI come into play. In this blog, we will tell you about Microsoft Project Online and Power BI, and how they can become a game-changer for your business? These applications are powered by Microsoft, and i2e can help you with the implementation as well as migration of your existing projects. Are You Already Using Project Online? Along with being a magnificent project management application, Project Online is also a precious data source. Leverage it correctly and it can give a powerful start towards making meaningful reports. This is where Power BI can change the way you look at the data. But doesn’t Project Online come with a reporting module, then why should you integrate Power BI? This is a reasonable doubt, which many of our clients expressed. Read the next section to find out. Why Integrate Power BI to Project Online? Power BI is a reporting tool that can analyze data and convert it into meaningful metrics for the business. Yes, Project Online does generate reports, but if you need customized reports, along with actionable insights, and smart visuals, then Power BI is what you need. Using Power BI, companies can do more than just creating reports, they can dig deep into the data and use the Machine Learning algorithm to predict trends. The best part is you can easily integrate Power BI to Project Online and eliminate the hassle of exporting data and manually generating reports. Integrating Power BI to Project Online will boost your reporting capabilities and help in smart decision-making. Power BI’s Components Using Power Q&A, you can create visuals by just typing in questions. For example, ‘who owns more projects,’ or ‘how many projects are owned per owner.’Power BI has a Power query option which can structure your data. Once the data is structured, the Data Management Gateway refreshes the data periodically and the new data will follow the same format, saving you time and effort.Power BI also comes with a Quick Insights feature which can churn your data and create subsets to give you valuable insights. For example, it can give you visuals of which project might cost more, or which project can fall out company’s goals in the future.There are other components such as the Power View and the Power Map, the former comes with an easy drag-and-drop interface, and the latter is a 3D geospatial data visualization tool. Both these tools help in creating superior reports. Along with creating impeccable reports, Power BI can accumulate data from various data sources, create visuals and share across global data centers. This helps companies to meet their compliance and regulatory needs. Power BI- The Game Changer Fetch data from various cloud services – helps you in making consolidated reports.Build smart dashboards- gives a holistic view of the business empowering teams to make informed decisions.Ask questions and get real-time answers- gives answers in the form of a graph or chart for quicker understanding.Scan hidden insights in seconds- never miss out any data or trend which can be helpful for the business.Secured live access from any device- easy to access through Power BI mobile apps. If you are looking for a way to make smarter reports, then it is time to adopt artificial intelligence tools that can pull data and allow you to visualize in your own way. If you need assistance in implementing Project Online and Power BI, connect with us. Our team of experts will understand your requirements and provide you with the right solution.
Decoding custom resource management in life sciences: A Q&A with Nicola Clear
Effective cross-functional collaboration in resource management is no longer optional—it's essential. In life sciences, where complexity, speed, and precision matter, organizations must evolve beyond spreadsheets and fragmented systems to unified, data-driven frameworks like Alloc8.Check out this blog where PPM Subject Matter Expert Nicola answers a few critical resource management questions in life sciences project management.1. How can organizations improve cross-functional collaboration in resource management?When getting started with resource management, organizations must assess PMO processes weighing the level of their maturity and interconnectedness with other functional teams. Following aspects need assessing:Resource management tools – stand-alone or connected to other PPM tools?Project management tools – are they paired with good reporting to bring the portfolio together?Is strategic portfolio management linked to integrated schedule, cost and resource planning?Is the PMO/Resource ecosystem a collection of Individual tools or a unified smart integration with data warehouse strategy?While larger teams in global pharmaceutical organizations have excellent strategic and project management tools, with resource management, often things fall short. Despite maturity in portfolio planning, most resource allocation still relies on disconnected Excel spreadsheets—built on the fly during crunch time. This slows decision-making, making it inefficient and reactive. There is also no clarity on which projects can be delivered in-house, what needs to be outsourced, or making the case for additional resources.This disconnect is a pain point in large organizations, especially in R&D environments with complex, fast-moving portfolios with tight budgets, and limited resources.To tackle this, i2e’s purpose-fit digital resource framework Alloc8 becomes critical in bridging the gap between high-level strategic planning and day-to-day resource operations.Here’s how Alloc8 helps manage resources across teams:Speeds up decision-making and improve alignment—making sure the right people are working on the right projects at the right time.Unifies siloed data across HR, PMO, and line operations into a single, real-time platform with live dashboards and alerts—giving teams a shared, accurate view of resources, skills, and timelines.A connected resource management system that integrates seamlessly into any existing portfolio ecosystem.The result?Clearer communication, faster decisions, and real collaboration—because everyone is working from the same up-to-date information. 2. What are the benefits of dedicated digital solutions like Alloc8 for named resource management?Managers often stick with Excel for resource management because it's familiar. Excel works for one-off analysis, especially in ad hoc instances, for teams of fewer than 10 people. But in large, complex R&D environments managing tens of millions $s in demand across diverse skill sets, it breaks down fast.When the workforce needs shift weekly, not quarterly, and capacity planning is based on broad skill categories, a dedicated resource management system brings critical transparency. It enables faster, data-driven decisions on what can be delivered, what needs funding, and where trade-offs are required.But the impact is not just operational, it's also qualitative. In R&D, where success depends on collaboration, a shared resource framework structure & processes reduces stress, clarifies priorities, and supports team well-being.When tools like Alloc8 genuinely makes work easier for managers and teams, adoption isn’t a battle—it happens naturally because at its heart Alloc8 improves colleague well-being - through communication and expectations supporting the individual’s role in the team sport of drug R&D. Why is this?The visibility of allocation drives meaningful & quantifiable dialogue between colleagues, managers, and teams. When an employee sees they’re assigned 40% to Project A, 30% to B, and 30% to C—and understands why Project B is the priority and who else is involved—it brings clarity and focus. This alignment drives engagement, improves delivery, and makes employees feel empowered, valued, and connected to the bigger picture. The right dialogue on resourcing between managers and employees enables trust and engagement to develop in projects. Once resources are assigned to projects, identifying skill or knowledge gaps is the next priority—something Alloc8 addresses head-on. Alloc8 identifies skill and knowledge gaps by integrating with enterprise systems and using advanced LLMs can automatically recommend targeted training and surface relevant internal knowledge. This transforms traditional scheduling into real-time workforce enablement—offering a futuristic, AI-driven way to align people with projects and goals instantly. It also uncovers cross-divisional shadowing or delegation opportunities, matching it to individual growth plans. As a result of this smarter alignment, faster upskilling employee retention improves, colleagues stay where they feel supported and developed.Refer to our white paper called “Solving the mystery of named resource management in life sciences project management for organizational effectiveness” for more. 3. What roadblocks and barriers do organizations face with digital solutions for resource management?Factors that deter life sciences organizations from doing named resources.Disparate data: Life sciences organizations often hesitate on named resources due to fragmented data across unconnected systems, overlooking how integration can unlock new insights.Manual effort: The perception that named resource management requires time-consuming manual data gathering and updates—especially in tools like Excel—can hamper adoption.Lack of automation: Without automated notifications, critical updates on resource availability and task changes are missed, causing delays and misallocations.Regulatory compliance: Concerns about compliance with country-specific labor laws, particularly in the EU, are addressed by Alloc8’s configurable framework that ensures both efficiency and regulatory alignment. 4. What are the challenges and opportunities when integrating FTE forecasting, resource allocation and time carding data for resource decisions?Challenges in cross-functional data integrationDisconnected data systems: When your PPM, HR, and contractor capacity databases don’t talk to each other, comparing forecasted demand to actual capacity becomes manual hard work. It gets worse when insourced contractors are tracked separately, making total workforce visibility nearly impossible.Mismatch in forecast vs actuals: In theory, matching forecasts to actuals is simple, but any inconsistencies in naming and activity labels across systems make it difficult. For instance, a PPM forecast may list “chemist” for Project AB-234,777, Workflow 2, Activity A, while the timecard logs “chemist” under a different activity—causing misalignment when attempting forecast variance analysis. Without governance & standardization, linking forecast, allocation, and timecard data, data analytics are slow and error prone.Challenges in data maintenance: Scientists and teams often deprioritize forecast data updates, preferring to focus on their core science work rather than business forecasts. Many distrust forecasts and view manual updates as unproductive. But with custom digital resource frameworks, much of this can be automated—named allocations can update forecasts, calendar events can feed into timecards, and AI can refine future forecasts with human-in-the-loop approvals.Opportunities in cross-functional data integrationConnected forecasting: Data integration across functions is no longer optional—it’s now technically possible and essential. As digital transformation accelerates across every part of the organization, static forecasting templates quickly become outdated.Seamless data flow: Leaders need up-to-date, connected insights to compare forecasts, allocations, and actuals in real time and to accurately measure the ROI of digital investments. Without seamless data flow between systems like HR, PPM, finance, and operations, organizations risk slow or misinformed decisions, resource misalignment, and missed opportunities.Enhancing workforce administration with Alloc8: Resource management tools like Alloc8 are designed to work with—not against—the workforce. When integrated into the broader tech ecosystem, they help reduce manual admin, surface actionable insights, and identify training, knowledge or resourcing gaps early. This frees scientists, managers, and leaders to focus on higher-value innovative work, advancing science, solving critical problems, and driving innovation all the while letting technology handle the complexity behind the scenes.5. What about resource constraints and how can life sciences companies handle them?Yes, resource constraints are BAU for most Pharma companies, it’s a sign of a healthy growing organization to have a book of work larger than the capacity. Resource constraints are a normal part of any growing life sciences organization—but they only become a problem when there's no clear process to address them. Handling resource constraints with rapid, structured action involves:Verifying if the forecasted demand truly exceeds capacity by analyzing gaps in FTE or budget by skill set. Using named resource data to pinpoint which projects are under- or over-resourced relative to priorities, enabling faster and more accurate decision-making.Resolving gaps requires aligning existing talent with strategic priorities, securing additional budget for outsourcing or hiring, or making tough trade-offs on lower-priority projects.Alloc8 makes this decision-making process real-time by flagging skill shortages, overbookings, and workload bottlenecks. When teams see that managers are actively identifying and addressing resourcing issues, it builds trust, reinforces a team-first culture, and supports both performance and well-being. As a result, organizations can manage workload demands to balance productivity and colleague well-being. 6. Explain the 4Cs to optimize named resource allocation Organizations have the best interest of business and employees when they use 4Cs to optimize named resources. Culture: When employees trust the governance process and the leadership backing is strong, named resource allocation is seen as fair and beneficial.Communication: Regular one-on-ones, face-to-face updates, and AI-powered task automation ensure everyone stays aligned and knows their priorities.Connected: Linking resource plans to business strategy, OKRs, and KPIs ensures every allocation supports high-impact goals first.Change Management: For named resources to deliver as much time needs to be invested in stakeholder buy-in and training as the digital tech solution to ensure lasting adoption and effective implementation. Forget this last step at your peril!7.How can organizations solve demand forecasting disagreements?Purist vs directional, correct?Forecasting demand is never 100% precise because it’s based on general templates and estimates, often includes extra buffer time, often forgets to account for tasks like capturing lessons learned—so the over- and under-estimations tend to even out in the end. Managers recognizing this can usually reach forecasting agreements.Skill effectiveness varies too. For instance, a newer employee may deliver at 50% efficiency compared to someone experienced, making named allocation essential for accuracy. Historical data showing consistent over-forecasting—like deliverables met despite named resources being 20% below forecast—helps refine future predictions and find the true average algorithm.When disagreements arise, resource managers can use data from named allocations and timecards to show how work was actually delivered guiding more accurate, AI-supported future forecasting.