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Stem - Make The Future With Heart

Project Planning


Stem has assembled an experienced and professional project management team covering a wide range of therapeutic areas. At the beginning of the trial, the Project manager formulated an efficient and feasible PMP (Project Management Plan) according to the clinical trial implementation Plan, which was approved by the sponsor and then implemented. In the process of clinical implementation, stem team will execute the project strictly in accordance with the finalized PMP, and provide efficient clinical project management services for the sponsor with the help of the scientific information management system.

Project Implementation Management


Stem pay attention to project information management, project using CTMS and man-hour management OA system, increase the information transparency, system planning, to fully understand the project's situation in real time, avoid communication, timely discovery project and routing to solve the problem, on the premise of guarantee quality speed up progress of clinical trials and enhance the project execution, improve the quality of clinical research, establishing systematic clinical research standard process, thus ensuring project standardization, improve work efficiency.

Project Monitoring


Stem will monitor each center according to the approved visit plan, and the inspectors need to monitor and visit in strict accordance with the inspection plan to ensure the frequency of the inspection. After each visit, stem CRA will prepare the visit report. The visit report and the follow-up letter should describe the monitoring process and confirm that the problem or any changes need to be resolved.The report shall be completed in accordance with the requirements of stem SOP, and the final draft shall be signed after being reviewed and approved by the PM, and submitted to the sponsor at the end of the project.

The Meeting Organization


During the clinical implementation stage, we assisted the sponsor to organize program discussions, researchers' meetings and other relevant project meetings, so as to ensure the smooth implementation of clinical trials through full discussions with researchers.

For the project meeting, Stem pays attention to the timely and efficient communication management, and communicates with the sponsor by telephone, meeting or message, and timely follows up the sponsor's project progress and needs; At the same time, regular team teleconferences and pmd-pm meetings are held, so that the internal team of the company can timely understand the progress of the project and solve the problems existing in the project in a coordinated and efficient manner.

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