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Scenario for Managing Clinical Projects

This scenario is an example process performed by the administrator and the project manager (PM) for the clinical trial. Your company may follow a different process according to its business requirements.

The PM works for a large clinical research organization (CRO) that has been awarded a contract to carry out a clinical trial for a pharmaceutical company and is responsible for setting up and running the clinical trial project.

Setup and Staffing

First, the PM enters some basic information about the project into Siebel Clinical and determines which employees should have visibility to the project data by entering them in the project access list.

To optimize the resource assignment, the PM first enters the resource requirements in the team workbook and then uses Siebel Assignment Manager to help with the staffing. The PM specifies the roles, skills, competencies, and availability required for the team and lets Resource Manager find the best candidate for the roles.

For this large project the CRO may need some subcontractors to complete certain aspects of the project. Because the subcontractors are paid on an hourly rate, the PM associates the appropriate billing rate list to the project. The PM also needs to add employees of the subcontracting company to the subcontractor resource list.

Other external contacts and accounts can also be added to the project. For example, information about the central laboratory and the primary contact at this laboratory are added.

Tasks, Activities, and Risks

Milestones can be set as tasks or activities. The PM can create them within Siebel Clinical Projects or import them from a Microsoft Project file. Each Siebel activity has a budget and the actual costs of these activities are updated as the project progresses. Periodically, the PM reviews these project costs, making sure that the project is staying within budget. Payments made to sites for subject activities are rolled up to the project costs.

Project risks are documented as they arise, as well as the resolution activities to address the risks.

Exchanging Data with Microsoft Project

To create a Gantt chart of the project milestones, the PM exports the project data to a Microsoft Project file.