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.
Conversations in Pharmaceutical
Sergiu Merca · Dec 6, 2023
Feb 5, 2024 Sergiu Merca replied Feb 5, 2024
Sirgiane Vianna Cardozo · Dec 14, 2023
Dec 14, 2023 Kiron Bondale replied Dec 14, 2023
Loretta Enweani · Nov 12, 2023
Nov 12, 2023 Loretta Enweani replied Nov 12, 2023
Prateek Aggarwal · Nov 2, 2023
Nov 2, 2023 Kiron Bondale replied Nov 2, 2023
Iheb Barhoumi · Sep 12, 2023
Oct 9, 2023 piotr jankowski replied Oct 9, 2023
Jeroen Verheijen · Feb 14, 2023
Aug 23, 2023 Emily Jones replied Aug 23, 2023
Iheb Barhoumi · Jul 27, 2023
Aug 1, 2023 Iheb Barhoumi replied Aug 1, 2023
Monika Krasteva · Apr 7, 2022
Jun 8, 2023 Miguel Figueroa replied Jun 8, 2023
PRIMITIVO BARRON · Aug 21, 2022
May 16, 2023 Latha Thamma reddi replied May 16, 2023
John Fraser · Feb 9, 2023
May 16, 2023 Latha Thamma reddi replied May 16, 2023
Advance Your Career
Medical writing and project management are two sides of the coins because one can write and produce quality documents to the regulators successfully only with managing the project effectively. The medical writer has to think because of the intellectual nature of the job, and one has to think through the concept, analyze, and interpret the data. This is not possible without coordinating with the core team members viz. clinician, clinical operations’ project manager, biostatistician, data manager, clinical research associates, publisher, research scientist, accounts and legal departments, facility (clinical site) staff, and the management of the Sponsor. At the same time confidentiality of the work and the information is of utmost importance before it comes in the public domain as this might involve the individual subject’s confidential information also!
There is a missing skill in how project managers approach problems especially in the pharmaceutical industry. Most project managers do one of two things before solving a problem. The first instinct is to review the problem regardless of how it is presented then jump straight into a solution. However, this can lead to solving the wrong problem and only realizing the wrong problem is being solved after it is too late. This leads to restarting the entire problem-solving life cycle or implementing a solution for the sake of “just doing something”.
By 2023, it is estimated that pharmaceutical sales will top $420 billion in the United States alone. Project management is the key to addressing the unique regulatory, compliance, and quality needs of the pharmaceutical industry. In this webinar, an up-scaling project - with the goal of increasing production efficiency - is presented in order to illustrate the complexity of integrating up to five quality gates within a project’s life cycle. The presenter will demonstrate how quality gates act as checkpoints to prevent bumpy project planning, execution, and close-out and thus increase odds for successful project delivery.
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
Save Time With Tools + Templates
This sample Excel project plan for pharmaceutical generic product development has been designed to show project flow from license requirement to milestones and WBS. It provides a real-time assessment from project inception for drug development in R&D to dossier submission with regulatory agencies.
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.
Learn From Others
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.