Site Selection SMT Resource Demand - Standalone Slide_Aug2025

[Audio] The Clinical Feasibility Lead or the CFL role is responsible for reviewing the resource demand for the study with the project lead to ensure the most accurate information is provided for the resource demand. The CFL must be familiar with the requirements of the study not just before and after the handover meeting, but throughout the study to manage accurate resource forecasting. During the life cycle of the study, the CFL will forecast hours based on the progression of site selection and the addition and of country or sites. It is also expected to identify risks as they arise during the life cycle of the site selection process, such as insufficient hours for task completion or requesting additional support for ongoing site outeach. The focus of resource forecasting is to ensure we customise the hours available for the study to meet the timelines for qualifications visits and final site selection. It's the CFL responsibility both before and after the kickoff meeting to check and confirm the hours resource to the study. The resourced hours will reflect the staff roles applicable supporting the survey outreach process. They will need review and provide the forecast for the following roles: Clinical Feasibility Leaders Site Feasibility Liaison; and Site Intelligence Analysts The CFL will communicate the hours sold depending on the following key areas. The Number of countries The Number of sites The Number of Panel Review Meetings which is based on duration of site outreach The Type of CDA, this can be Electronic or Paper based The Number of sites required for outreach The Development of site list, which would include the COI and DD review process The complexity of the study The study Therapeutic area and indication The Status of the EPIC Plan Confirmation of Internal and external meetings Requirement of Study specific training If adjustments are required to the scope, units or hours, it is critical the CFL informs the Project Leader about this as soon as possible. The aim of resource forecasting is to ensure the Clinical Feasibility Leader, Site Feasibility Liaison; and Site Intelligence Analysts, have sufficient hours for the study at which are specific to the deliverables of the role in a transparent and accurate way to ensure PAREXEL continues to deliver on project timelines, sites and work delivery. This could be influenced by the following: New countries New sites Or if there are PI or site staff changes Any extra hours identified and captured in this review stage of the protocol should be reflected in the applicable change in scope for the study and must be communicated to the project lead for documentation as soon as possible. Please refer to the Newly Awarded Studies column, as a guide to additional hours that may be required in the ongoing protocol review. In the monthly review phase of the resource forecasting, the CFL may consider the following topics. Identifying insufficient hours to complete the applicable and or new work. Consideration for additional staff to complete the additional workload or new workload. Consideration whether tasks require more experienced staff or highlighting potential gaps and staff experience which could impact the delivery of the workload in the prescribed time frame. During the ongoing review of the study, the CFL will also be asked to forecast hours for the Clinical Feasibility Leader, Site Feasibility Liaison; and Site Intelligence Analyst. This includes a schedule review and.