An emphasis on well-controlled clinical trial programs and increased regulatory pressure for more meaningful, clinical data means that medical device companies must develop strategies to expand their capabilities for carrying out clinical trials.
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This session will give you a unique perspective in the possibility of using lean and agile in unison, not only to all kinds of projects, but at overall organizational project management, as well as a top down view on your organization as a Lean-Agile (LeAgile) Organization. The session will endeavor to link the conceptualizations from top-down as well as bottom-up approaches to enable audience get a wholesome picture of a LeAgile Organization.
You no doubt understand why innovation is needed in your organization. But do you struggle with the how?Innovation is a strategic lever you can use to grow your business and remain competitive. While you no doubt recognize “why” innovation is needed, you may struggle with “how” to do it. In this presentation,we will explain how organizations can embed innovation as a key capability by equipping individuals and teams with a structured process and
To provide an overview of how the Johnson & Johnson Project Management and Capacity Management Organization work with Therapeutic Areas and Compound Development Teams to assess the book-of-work demand, impact on functional area budgets and capabilities to provide insightful information and data for decision making purposes
Research demonstrates that as many as 60% of IT projects fail in some area. Whilst the causes of project failure are well documented, the impact that these failures can have on a Project Manager, is a topic that is less frequently discussed. Although people might not always feel comfortable talking about how they respond when a project fails, as Project Manager's we are likely to be faced with situations in our careers where things don’t go as expecte
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This report helps you provide a concise and precise update on the current status of a clinical study and the achieved progress during the reporting period. It is usually distributed to a sponsor of the project, as well as the management of the company where the PM works. The main benefit of this report is that it addresses the major project constraints and provides only the relevant information needed to successfully manage the project and communicate with a diverse international team, typical for a matrix-based pharmaceutical company.
Clinical research involves numerous daily monitoring and controlling activities. An integral part of every clinical research study is a clinical monitoring report. No matter if you are a seasoned clinical research professional or an enthusiastic newbie, the right monitoring report template can make your life much easier and assure the delivery of critical information.
The Activity List template is intended to provide a detailed list of all scheduled activities after the breakdown of work packages. This would provide a basis for estimating, scheduling, executing, monitoring and controlling the project work. This template contains a generalized template with detailed instructions to fill in, followed by a sample personalized to the bio-pharmaceutical industry.
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The demand for drug discovery organizations to produce viable drug candidates is critical, as they try to progress pipelines in a pharmaceutical industry facing increased complexity and costs. A survey of drug discovery scientists was initiated. Respondents overwhelmingly point to project management practices as a valuable asset and offer several actionable suggestions.
With the increased emphasis within the pharmaceutical industry on business productivity through the integrated application of Lean Six Sigma (LSS) and disciplined project management methodologies, this paper offers an expanded definition of the classical Define-Measure-Analyze-Improve-Control (DMAIC) project life cycle by incorporating aspects of PMI's PMBOK® Guide methodology and creating a new life cycle, DMAI2C2, that will assist productivity improvement project teams in creating a project roadmap that leverages the best of both the LSS and PMBOK® Guide methodologies.
This article explains the rationale behind the creation of an in-house, customized project management methodology, iMAP, at a rapidly growing pharmaceutical company. The authors also describe the priorities that were selected to start with its implementation: a solid project initiation, a clear project life cycle, a special attention to risk management, a first step in reporting standardization, and specific attention to the activities necessary for the transition to operations. They provide an overview of their approach to IT project governance and how a defined project management methodology is the key for its success.
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