Outsourcing of clinical trials is frequently done by pharmaceutical companies because they don’t have the expertise to run those trials, they need to expedite the timelines, or they are working at capacity. In this article, we explore key outsourcing activities for Phase I clinical trials from a PMBOK® Guide lens to identify key success factors.
10 items found
For decades, predictive project management approaches have been applied with success. But now more than ever, more flexible (and faster) decisions are required in complex construction projects—where change of scope is frequent, and the need for new factories is crucial to remain competitive.
Managing a capital project is not for the faint of heart. Navigating the complex web of planning and execution requires an understanding of many aspects in the project delivery lifecycle. One key approach for PMs is to focus on achieving operational readiness once the project is complete.
When companies hire a contractor to conduct work, how much ownership do the companies retain for that work? Where is the line between managing and oversight? Definitions in management roles help reduce confusion within a contractual relationship—for those on both sides of the equation.
What areas of the pharmaceutical industry related to clinical trials can benefit the most from adopting an agile approach, which is based on lean, no-waste process management? More importantly, after you have figured out where you want to apply agile, how can you make sure it gets adopted across the organization?
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.
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.
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.