I.Participating countries We are focusing our clinical trial trail phase III study trials in USA, Japan and Germany as we have checked feasibility for those countries for Type II Diabetes Mellitus (T2DM) patients who have been prescribed Kombiglyze XR by their physician for the treatment regime and how it is responsible to induce the heart related diseases. We will conduct Phase 3 clinical trial with time limit of 2 years. ii.Kick-off Meeting: Date, time, location, participants. A kick off meeting is a significant element of any project initiation. It represents the commencement of project and creating project deadline and providing an opportunity to educate clinical trial staff and clinicians about the entire project. Our goal of theshow more contentWe will divide the team in different groups designated to different section of protocol like patients inclusion and exclusion criteria, safety, analysis. Each group will study their section and shared information with the whole team.3. Understanding of project time frame, scope and budgetOut team will focus on positive and negative risks. The lead data manager will provide project time frame, scope, and budget during the proposal process. Any changes can be proposed in the kick-off meeting. It is not only project manager responsibility about the project time frame and budget, it is whole team responsibility.4. Coaching the science behind the studyEach and every member of the team will understand the science behind the clinical trial provides significant background for the tasks that will be allocated and related decisions will be considered. We will take help from medical monitor or other suitable expert to arrange an outline of the therapeutic part and sign, to talk about the specific mechanisms pertinent to the manufactured goods being evaluated, and to talk about earlier and rival trials that may offer context to ourGet Access
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