At Kaizen Clinical Services, we feel that strong project management is the key to the success of your project. Kaizen Project Managers provide supervision of not only the Kaizen project team, but of all vendor project teams as well, to ensure all aspects of your study run smoothly. This can include International Service Providers, Imaging vendors, Central laboratories, Specialty Labs and Central IRBs.

Right from the start of the project, the Kaizen Project Manager will meet with you to discuss how the study will run and compile all of this into a comprehensive project plan. This will include plans on all aspects of your program: Communication, Monitoring, SAE and Data Management.

Once your study is up and running, the Kaizen PM will manage all project timelines and deliverables while always being mindful of budget, to ensure your projects stays on track from start to finish. Communication being the key, the Kaizen Project Manager will prepare and deliver project status reports as often as needed to keep your mind at ease.

As always flexibility is a key in managing clinical studies and that applies to our Project Management approach as well. Kaizen PMs are here to take on as much or as little as your group needs to make your project a success.

• Supervision and guidance of project team
• Develop, implement and monitor compliance to all aspects of the Project Plan
° Communication Plan
° Monitoring Plan
° Serious Adverse Event (SAE) Plan
° Data Management Plan
• Manage project timelines and deliverables
• Prepare and deliver project specific status reports
• Management of all project vendors
° International clinical service provider
° Imaging vendor
° Central laboratory
° Specialty laboratory
° Central IRB