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project management in pharmaceutical biometry and data ...

project management in pharmaceutical biometry and data ...

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226 Martin Wilhelm descriptions and must be communicated to 2. The PM organization should provide ser- at least all directly cooperating units. Ideally, vices such as time tables, meeting minutes, all required definitions have been worked out and project plans to cooperating depart- in cooperation and consensus with the customers during the conception phase. Afterments.wards the start-up phase can begin. Both measures will effectively support the After the first training and education in-house acceptance and provide evidence of round, the start-up phase should be pushed the potential. Usually at this point discussion forward by the project managers themselves arises as to how project management can be but should be supervised and supported by supported effectively by software tools. A a high-ranking steering committee. It should few recommendations regarding key criteria be mentioned, however, that the implementa- for the selection of project management soft- tion of project management in a complex ware are provided. The tool’s database should environment may very well last for more than be open to make sure it can be linked to other one year and that miracles cannot be ex- company systems, especially those for study pected within a short period of time. Activi- tracking and controlling. Further, it should ties should, therefore, be focused on the most be a multi-user system to support the build- pressing projects and the company should up of master plans from decentrally main- not attempt to establish all methods at once tained project plans. Next, it should display (Figure 4). the schedule as Gantt charts, ideally showing Rather, it is important to establish the op- the logical constraints, it should display reerating teams and the team management source allocations and at least one project (meeting and reporting routines, project structural plan and should produce an attracplanning and follow-up, troubleshooting). tive and informative graphical output. Please Two approaches are critical to success in this note that according to the author’s experiphase: ence, automated resource driven scheduling and on-line project steering without respec- 1. To establish the new working relationship tive team sessions do not work sufficiently to cooperating units (medical study team, and should be avoided. marketing, etc.) on a team-to-team basis, During the start-up phase the education and of the project managers should continue. The 2. To install the reporting lines and define key elements for this are methods of project the content of messages to the top manage- planning and controlling, basics of business ment. management, methods of decision making, business process redesign and organizational The first is important for correct project plan- change, presentation techniques, group dyning and steering and hence directly influ- namics, and quality management. This pro- ences the team’s success. The second is critigram should be designed as a whole rather cal because reporting to top managment can than consisting of single unrelated work- elicit unpredictable reactions especially in shops and seminars. Professional coaching times of project crises, and strongly influ- during this time is recommended. When the ences team credibility in the long run. During teams are well established on a basic opera- the implementation phase, where the new or- tional level, which should be achieved after ganization is still unstable, an open informa- approximately one year, the tasks of the projtion policy regarding the gains and draw- ect managers can be enlarged and enriched. backs should be followed and there are two Out of the existing, validated project plans rules that make life easier: a corporate data management master plan should be created that forms the basis for 1. The envisaged goals should be handy and multi-project and resource management and easily achievable, and budget control. Please note, that this is only

Project Management in Pharmaceutical Biometry and Data Management 227 possible if the individual project planning of these serious, in the long run intolerable every team is standardized. Also, attempts to problems by linking clinical and biometry detect the potential for improving the exist- teams together. It is mandatory, however, to ing business processes and the business dis- have or define the organizational framework tribution plan (ie, the global responsibilities to create and maintain corporate standards of corporate data management) should be and to distribute the respective libraries in started now. In close conjunction with this close cooperation with the clinical team and and of equal importance is the approach to enforce the corporate data management stan- the drug safety unit. dards (see below). Process Improvement PROJECT MANAGEMENT OPERATIONS This attempt clearly is the most difficult job to do. Consequently, it is rarely found in the task description of project managers. Never- It would surely blow the frame of this paper theless, it is most logical to establish, as far to try a detailed discussion of all possible as clinical development and postmarketing project management operations. Rather, the surveillance are concerned, this function in key elements of selected major tasks will be data management since most of the easily described, which, it is hoped, will fertilize influenced time critical factors lie in this unit. further discussions in the reader’s environ- It makes sense, therefore, to analyze pro- ment. In the process of drug development cesses from the data flow point of view. The and maintenance, data management as a service unit has to handle many interfaces and steps are as follows: interaction partners. For the sake of speedy 1. Definition of the key processes to analyze and high quality performance, an excellent (ie, clinical trials, postmarketing experi- interface management is mandatory. This ence report, etc.), split-up into subprocwill consume approximately 50% of the caesses, identification of interfaces, responpacity of a project manager. Further, approxi- sibilities, steering committees and other mately 30% will be neccessary for planning, relevant organizational factors, budgeting, and resource management and 2. Analyses of the processes, subprocesses hence, approximately 20% capacity is free and interfaces regarding efficacy, redun- for accompanying attempts at improvement dancies, media-breaks, and information and gains in quality. sources and sinks, 3. Redesign including organizational mea- Standardization Many pharmaceutical companies are in or sures and technological support, and 4. Implementation of the proposed changes. just through the process of defining global It should be clear that business process biometry standards in order to create homo- redesign cannot stop at the borders of a single geneous data pools and to exploit the advan- unit. Rather, it is an interdisciplinary ap- tages such as expeditious study set-up, data proach and hence requires the full support of acquisition and cleaning, speedy reporting the top management. If carried out properly, and metaanalyses, and global drug safety however, it is the best way to positively influ- management. Frequently, the inventors are ence productivity and cost-effectiveness and confronted with problems in implementing to realize a permanent adaptation and im- standardization in the marketing domain provement process. Frequently, the question (Phase IV trials or observational studies) or arises as to which business functions should with lack of obedience even in Phase I–III be centralized or decentralized. Even though clinical teams. Professional interface man- there is no universal answer, as a rule of agement will definitely contribute to solving thumb, organizational units should be decen-

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