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.
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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.
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.
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.
Having worked as a project manager delivering technology solutions to life sciences clients for close to a decade, this author has noticed common themes that help ensure project success. Here are six project management takeaways from delivering projects to regulated companies.