Achieving maximum efficiency without sacrificing quality is a daunting task for clinical trial managers. Paragon has worked with numerous clients in the life sciences industry to help them determine the means to achieving this efficiency. In the recently released Paragon Solutions whitepaper, “Creating a Roadmap to Clinical Trial Efficiency,” we outline the steps needed to create an environment (processes, organizational structure, and IT systems) that enables the improved operations.
What is Clinical Trial Management Efficiency?
Efficiency can be defined as “the extent to which time, effort or cost is well used for the intended task or purpose”. When brought into the realm of clinical trials efficiency is using resources (money and human resources) to execute the clinical trial within the timelines established in the project schedule. Clinical trials are very complex and very expensive, and far too often are made more complex and expensive by the processes and technologies that the clinical team is forced to adhere to.
Why is Clinical Trial Management so Inefficient?
Many life sciences companies are held back by their own inefficient processes that have compounded over the years, which keep them from achieving efficient clinical trial management. Adding to the challenge of compounded processes, are the regulatory factors and the business environment surrounding the life sciences industry:
Life sciences companies have no choice but to adhere to regulations, which often make their processes less efficient but are absolutely necessary to avoid legal and regulatory repercussions.
In terms of the business environment, the trend toward outsourcing partnerships and the increase in mergers and acquisitions within the life sciences industry over the last decade also negatively impact efficiency. Negotiating the landscape of process “whose to use”, re-educating staff to changed processes, and ensuring data and content quality in these complex business arrangements impedes efficiency.
Does Clinical Trial Management have to remain inefficient?
Thankfully clinical trials can be run more efficiently. It is not easy, but it is possible to change the operating environment to support, rather than hinder, the clinical team. This involves designing more efficient internal management processes, decreasing the need for human intervention, reducing manual reporting tasks and making processes more transparent for all members of the team, including vendors and partners. All the processes, systems, documents and data involved in the life cycle of a clinical trial need to be reviewed/analyzed. This whitepaper explains the many obstacles to efficiently and effectively manage clinical trials of any size and scope, and discusses how a Clinical Architecture roadmap is critical to more efficiently manage clinical trials in the future.
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Chris McSpiritt is the Clinical Practice Lead for Paragon’s Life Science Research& Development team. Chris has over 10 years of pharmaceutical industry experience in R&D and has applied his business architecture, business process management, and analytical skills to help pharmaceutical companies improve the conduct of clinical trials for global life sciences companies. Chris holds a BA in Psychology from the University of Notre Dame. He is an active member of the Business Architecture Guild, Association of Business Process Management Professionals, Project Management Institute, and Drug Information Association.