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Scenario for Managing Clinical Projects

This topic gives one example of how to manage clinical projects. You might manage clinical projects differently, depending on your business model.

This topic includes the following information:

• Setting Up and Staffing the Project
• Managing Tasks, Activities, and Risks

Setting Up and Staffing the Project

A product manager works for a large CRO (clinical research organization) 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 project for a clinical trial.

First, the product manager enters some basic information about the project into Siebel Clinical and determines the employees that can have visibility to the project data by entering them in the project access list.

To optimize the resource assignment, the product manager first enters the resource requirements in the team workbook and then uses Siebel Assignment Manager to help with the staffing. The product manager 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 might need some subcontractors to complete certain aspects of the project. Because the subcontractors are paid on an hourly rate, the product manager associates the appropriate billing rate list to the project. The product manager also must 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.

Managing Tasks, Activities, and Risks

Milestones can be set as tasks or activities. The product manager can create them within projects in Siebel Clinical. Each Siebel activity has a budget and the actual costs of these activities are updated as the project progresses. Periodically, the product manager 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.