Project Management
The basis of a successful clinical study is well-planned and effective project management. VeritasCRO provides the needed organization, time management, and risk analysis; which are essential for a successful outcome in project management. The steps of a project are always prepared in with detail. By determining the high-level expectations such as the reasoning for the need of the project, its possibility of applicability, and requirements for completing the project; the preliminary stage of the project is designed. Integrity and continuity are the main components of an effective project plan. Duration, cost and performance of the project are compared in each step. Adjustments are done accordingly, which are significant for the process to be conducted correctly.
Steps of project management consist of skill sets; the tasks are completed with the resources required for reaching pre-set goals within the predefined time scale. All projects consist of a series of processes, which are outlined with the following basic steps:
1.Initiation
2.Planning
3.Conduction
4.Observation and Control
5.Analysis and Reporting
These five steps represent the life cycle of a study. Therefore, a management plan is essential for effective project managing. The plan should include the details of the adjustments; which have been done for serving the data tracing committee and orientation committee, and especially for controlling and improving all aspects of a study (including the manner that the study is conducted on a daily basis). Another important aspect of the plan is the development of a rigid statistical plan aimed to conclude the study efficiently, supported by sufficient time and resources. The plan defines what the researchers are trying to achieve, how the resources will be utilized and in which time period will the study be designed. Besides, it should determine the way that the predefined processes will be followed, for the sake of delivering it as planned. As the trial progresses, the plan can later on be reviewed and refined. The results from the project management process supply the approved projects, and information to be applied on resembling studies in the future.
References:
1.Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78, 2010
2.Fry A, Mortimer K, Ramsay L: Clinical research and the culture of collaboration. Aust J Adv Nurs. 1994
3.Project Management Institute: A Guide to the Project Management Body of Knowledge 1996
Coming together is a beginning; keeping together is progress; working together is success.
Edward Everett Hale