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T-35: Improving Probability of Success – Better Project Outcomes through Scale Appropriate Stage Gating

Poster Presenter

      Catherine Joan De Castro

      • Associate Director
      • QuintilesIMS
        United States


Develop tiered project categorization matrix as component of implementing a scale-appropriate approach to project governance and risk management, apply categorization to inform algorithmic approach to resourcing, optimize timing for Stage Gate review, design system and dashboard to visualize results


Work involved analysis of project metadata and lessons learned to determine correlation between project size, complexity, required resources and governance. Outputs were used to design a matrix and algorithms. Highest inflection points in a project lifecycle were used to determine gate milestones.


Robust planning and risk management are critical to delivering successful outcomes. Stage-gate encourages team engagement and active risk mitigation to prevent future problems and delays, as well as a key tool for providing transparency. Stage-gate processes are a key component of executing a risk-based approach to monitoring clinical trials. Complementing the knowledge and expert judgment of project managers with a standardized method allows us to design an improved execution paradigm, where we can continuously identify and remedy gaps throughout the project lifecycle, while balancing the need for minimal intrusion and maximum efficiency of the project team. Step 1 in the development of the categorization matrix includes identifying ranges for a projects size, along with factors that influence the level of complexity of that project such as difficulty associated with a particular patient population to organizational and industry experience with a particular compound or delivery method. Step 2 in the process development includes developing the appropriate team resourcing algorithm and ratios, required team competencies, along with thresholds in which particular resources can be combined to maximize efficiency and minimize handoffs. Step 3 involves determining the optimum time points in which to conduct Stage-Gate reviews, utilizing the project’s categorization to determine the rigor applied to the review, as well as identify the most appropriate stakeholders to oversee particular stage gate reviews Step 4 involves analysis of a cross-section of projects and their performance, as well as identifying any interdependencies between the project categorization and having right skill levels assigned to confirm the robustness of the framework Step 5 includes embedding the categorization, resourcing, and stage gate into the existing technology framework to allow improved automation and oversight of the process


The adaptation of this project management framework and Stage-Gate to clinical trials sets the stage for the success of the project in terms of improved planning and oversight, streamlined project review cadence, increased transparency, and better stakeholder engagement. It helps to answer critical questions related to planning: How to qualitatively assess the uncertainty and risk associated with this project? What team skills and allocations should be assigned to ensure effective management? When should stakeholders be mobilized to perform project reviews? Full scale adoption of the process requires a rigorous, multi-phased approach. With efforts focused on implementation, a streamlined training approach, and an integrated technology support infrastructure, we were able to embed the process into day to day operations and increase the odds of successful project delivery.