LEAD FOR SPONSORS
Simplify Clinical Study Forecasting and CRO Oversight
Manage the complexities of budget tracking, change orders, and out-of-scope tracking effortlessly.
MARKET PROBLEM
Outdated Contract Budget Management Creates Inefficiencies
in Clinical Operations
Pharmaceutical contract budget management relies primarily on Excel and outdated custom-built solutions, leading to manual tracking, poor visibility into milestones and spending, and frustrating inefficiencies for Business Operations, Finance, and Project Management teams. These archaic approaches result in audit findings, financial misreporting, and prolonged Change Order negotiations, driving up costs and labor. It’s time to modernize this process for better efficiency and control.
Disparate Vendor Reporting Causes Data Discrepancies
Vendor-led reporting, such as the tracking of Change Notification Forms (CNFs) creates irreconcilable data, making it difficult to consolidate accurate information, leading to inconsistencies and misaligned budget tracking across clinical operations and finance teams.
Manual Excel Processes Slow Down Operations
Poor execution often results from insufficient planning, overreliance on CRO models, inadequate proposal due diligence, and failure to leverage historical data for faster costing insights and deviation detection.
Lack of Analytics Limits Early Risk Detection
Lack of investment in clinical infrastructure has led to limited insight into service costs across essential trial areas, from CRO execution to eClinical tech, translations, lab work, imaging, and patient recruitment.
Compliance Risks Rise with Vendor Financial Mismanagement
Purchasing millions of dollars in clinical services without robust pricing intelligence exposes organizations to financial risks, inefficient budgeting, and potential overspending. Strategic pricing insights empower informed decision-making, enabling effective cost management, competitive bidding, and maximized ROI on clinical investments.
OVERVIEW
Boost Efficiency and Accuracy in Clinical Contract Management
Clinical Maestro LEAD is the industry’s first automated platform for unit-level contract reporting, tracking study progress, actuals, and forecasting. It provides a single source of data, enabling stakeholders to predict change orders and gain full control over budget management and forecasting.
Earned Value Analysis in one click
Reduce analysis time by up to 80% with instant project performance tracking. LEAD supports the tracking of units completed or forecasted for completion, based on operational and CRO reported data, enabling detailed Earned Value Analyses at activity level.
Tracking of actual units performed and milestones achieved
LEAD reporting provides insights into actual activities and milestones completed for contract budget management. Increase your tracking accuracy and invoice reconciliation by 95% with real-time monitoring of units and milestones.
Streamlined Change Order Management for Accuracy
LEAD automates change notifications, enabling real-time tracking, approvals, and traceability. Service Providers use an out-of-scope tracker to ensure seamless integration of approved changes into proposals with accurate documentation.
Easily measure where you are with the study relative to cost, time, and operational drivers
Improve forecasting precision by >90%, comparing cost, time, and operational metrics over time, and across studies to understand your contract spending and CRO performance, to avoid costly change orders and anticipate budget deviations.
Gain visibility on spend and activity variances
Reduce budget variances surprises through early detection of discrepancies. LEAD replaces monthly activity reporting in Excel and change notifications forms through in-system reports that can be analyzed through side-by-side powerful comparisons.
Avoid change order surprises with earlier views of trajectory
Cut change order reconciliation delays and manual effort through advanced forecasting of project trajectory. CROs leverage intuitive workflows to report anticipated future spend and out-of –contract deviations enabling Finance, Project Management and Outsourcing teams to work in a highly coordinated manner.
Ability to set forecast window
Enhance future planning through the ability to set tailored reporting windows that match your forecasting schedule, be it routine monthly reporting, mid-study reforecasting or preparation for governance meeting
Seamless integration with SOURCE and Core Ecosystem
When purchased together, LEAD offers a natural extension to SOURCE [link to product page], by converting awarded contracts into reportable contracts. To further accelerate the reforecasting process, LEAD can also be integrated to your data lake or preferred financial and eclinical systems, such as CTMS.
AI Powered Historical Contract Ingestion
Managing the contract budgets for new clinical studies is certainly a game changer, but often, Sponsors have multiple ongoing studies running in parallel, that also need tracking. Clinical Maestro team is experienced in transitioning legacy contracts first into SOURCE and then into LEAD for future actuals reporting and reforecasting and change order management.
BENEFITS
Streamline Clinical Contract Management with
Automated Tracking
Clinical Maestro LEAD reduces manual tasks, improves data accuracy, and offers full visibility into contracted budgets and CRO financial and operational performance. Gain control over study budget reporting with synchronized tracking and predictive forecasting for better decision-making
Accelerate Processes and Improve Visibility
Eliminate manual tasks like data aggregation and comparison with automated workflows. Gain full communication logs, streamlined change approvals, and faster review times, all while improving visibility into scope changes for quicker decision-making.
Minimize Compliance Risks and Misreporting
Achieve over 95% reduction in misreporting of actuals and out-of-scope tracking. Improve data quality and forecasting accuracy, ensuring better compliance and minimizing financial surprises associated with contract management.
Centralize Data for Full Transparency
Leverage a central hub for managing actual activity completed and anticipated unit spend. Access comprehensive dashboards for side-by-side comparisons and analytics, ensuring clear, transparent visibility into all aspects of contract management. Connect LEAD to your internal ecosystem, such as financial reporting software, CTMS and other project management solutions, to achieve even greater efficiency in study reporting and budget management.
Streamline Processes and Boost Efficiency
Increase team efficiency, collaboration and activity visibility with over 90% reduction in manual labor for contract reporting and reforecasting activities. Streamlined workflows optimize processes, allowing teams to focus on higher-value tasks and improving overall productivity.
WHY CHOOSE US
LEAD Is the Ultimate Solution for Contract Budget Management
Unlike disparate point solutions, that either track the budget, or the operational study drivers, LEAD focuses on the end-to-end contract budget reporting, capturing both the cost drivers and the activities completed, to increase forecasting transparency and accuracy. Truly unique in LEAD is the focus on Service-Provider reporting, as opposed to Sponsor-led reforecasting. We believe your CRO partners have the best insights into both current and future activities completion and can best report anticipated out-of-scope activities. Add to the mix the unprecedented level of granularity that comes with both unit level reporting and milestone tracking, to gain unprecedented visibility on change orders and trajectory vs. budget.
Complete Contract Lifecycle Management
LEAD integrates with SOURCE to support all stages of contract management, from negotiations to execution and budget monitoring, reducing inefficiencies and reporting errors. Out-of-scope tracking in LEAD automatically integrates with the Change Order management in SOURCE significantly reducing the reconciliation effort and contract turnaround time (TAT).
Ultimate Collaboration and Transparency
Integrates Fair Market Value data and analytics to provide objective, informed decision-making and budget management and out-of-scope activities into change order processing.
Actionable Data-Driven Insights
No other sourcing platform is equipped with bid grid mapping, SOW generation, milestone-based RFP cashflow simulator, or the ability to source with strategic partner agreements, such as fixed cost templates.
RESOURCES
Explore Expert Insights and Resources for Clinical Excellence
Webinars
Technology for Fast, Accurate Planning and Budgeting
Leading biopharmaceutical sponsors trust PORTFOLIO for pipeline planning and budgeting with superior results and reported more than 10x Return on Investment.
Read more
Blogs
Driving Customer Success Through Governance: Transforming Pharma Vendor Management with AI Innovation
Effective vendor governance is essential to ensure operational success, cost efficiency, and regulatory compliance.
Read more
Case Studies
Streamlining Vendor Management: How a Leading Biopharma Company Found Success
Read more
DEMO
Request a demo
Discover how Strategikon’s advanced solutions can streamline your clinical trial operations. Request a personalized demo to explore how our tools transform budgeting, vendor management, and outsourcing efficiency for pharma and biotech.
