Pharmaceutical Company Improves Clinical Study Development and Management Capabilities
Project Assistants’ Case Studies
Janssen develops and markets unique biopharmaceutical therapies. Innovative products focus on the management of three major disease areas: cardiovascular disorders, immunologic disorders and cancer. Their products help physicians deliver innovative treatments to improve human health and restore patients’ quality of life.
Janssen’s Clinical Logistics Division was looking to replace their existing Clinical Study Database (CSD). Project plans were being stored in multiple places, with little or no standardization. Because specific clinical study-related details were not captured uniformly, there was no way to look at the entire portfolio, or perform “What If?” analysis.
The Clinical Operations Division’s overall goal was to allow consistent management of clinical study portfolio data, including the ability to provide visibility of all relevant information associated with each study within a single system. The division was also looking for a more efficient way of calculating and reporting resource capacity and demand information.
Additional problems included the following:
Users outside of the US were unable to view existing project plans.
The process of developing new project plans was so cumbersome that it was impossible for project managers and stakeholders to generate hypothetical project plans, or to perform “What If?” analysis.
To best meet the Clinical Logistics Division’s stated objectives, Project Assistants guided the design, configuration and implementation of a Microsoft Project environment.
The implementation process began with a complete assessment of the current organizational environment, as well as gathering, documenting and reviewing the requirements needed to configure and implement the Microsoft Project environment. Project Assistants’ engagement manager focused on accurately mapping and capturing all information needed in the Microsoft Project implementation. Through this process, Project Assistants was able to gain a better understanding of the organization’s key project planning, executing and control functions so that those requirements could be translated into detailed design points for software configuration and implementation.
The next step in the implementation process was to install Microsoft Project and Microsoft Project Server. Key to the success of the installation process was teaching the Server Administrator how to implement, configure and support Project Server.
The Microsoft Project Pilot Solution was configured based upon the requirements gathered at the beginning of the implementation process. Project Assistants built and configured Janssen’s solution in its development lab, and later installed the configured solution into the organization’s environment. The configured solution included the following:
Configuration of several Project Center views to provide easy delivery of key Project Management data for senior management review
Configuration of several Web Access project-level views
Assistance with the definition of enterprise resource skills and the resource breakdown structure (RBS) for use with Microsoft Project Enterprise Resource Pool
Project Assistants developed a customized Project Initiation Wizard, based on a standard template, to ensure uniformity across all new projects across the enterprise. This easy-to-use wizard captures all required study-related custom fields, selectively removes unnecessary tasks, and establishes the appropriate task links.
Next, Project Assistants developed a “selective write protection” functionality, to ensure that some custom fields are read-only and that planners cannot delete “coded” tasks, but have the ability to modify specific, predetermined information.
Project Assistants also researched and developed a resource demand algorithm and resource capacity import tool, which allows the project managers to immediately take a newly generated project plan and apply appropriate custom resource contours.
Following acceptance of the pilot solution configuration, the pilot was installed at Janssen’s site. Once the pilot solution was successfully installed, training became the engagement focus, as Project Assistants provided in-depth training for project managers.
Microsoft Project Server and Microsoft Project Professional are currently installed and used successfully within Clinical Logistics to manage clinical project plans. All new clinical project plans are being created from a standardized template containing the structure and tools necessary to enter and maintain required study information. Because the Project Initiation Wizard captures all required custom fields, reporting and status information across the enterprise is more efficient and accurate.
Additionally, the Project Initiation Wizard has reduced the previously cumbersome process of building a new project plan from approximately one day to only a few minutes. Because of this added efficiency, project managers and stakeholders are easily able to build hypothetical project plans, to see if adequate resources are available to perform new activities.
Project plans can now be viewed globally, across the enterprise, even by users without access to Microsoft Project.
Additionally, high-level algorithms will soon be used for each of twenty skill sets within Clinical Operations to compute study-specific resource demand estimates for each clinical project plan. The resource demand algorithm and resource capacity import tool has been tested and is fully functional.