“I strongly believe that having a sound process within your organization, and strong discipline within yourself as a project manager, can help bring down the cost run-offs and complete your [clinical trial] project on time and on budget,” says Vatche Bartekian, president of Vantage BioTrials Inc. in Canada.
“If we consider that, on average, it takes a sponsor $250 million to develop a new drug, up to 12% of that cost can potentially be wasted—that’s $30 million—on poor project execution leading to delays,” Bartekian says, citing a 2016 study by the Project Management Institute on “Pulse of the Profession: The High Cost of Low Performance.”
“It’s pretty much a given fact that poor execution of a project leading to delays, or even outright failures, would have devastating results not only for the drug developer, but for everyone down the business chain from sponsor to patient,” Bartekian adds.
The stakes are high for everyone in the business chain. For the patient as the “ultimate consumer,” it’s about hoping to benefit from innovative treatments that can relieve their symptoms, increase their quality of life, or cure their illness. Contract research organizations and sites also carry a huge stake in the process (least of which is their reputations) if things go wrong during a clinical trial’s lifecycle.
Effective Project Management to Streamline Your Clinical Trial Workload
Join Vatche Barkekian at ACRP 2019 this April and learn the essential factors of effective clinical trial project management. Studies are complex, time-intensive, and leave little to no room for error. Discover effective tools for effectively assessing your workload, prioritizing tasks, and walk away with practical tips for successfully managing individual research projects.
“I believe the focus should always be on creating a strong culture of effective project management skills and nurturing an environment where employees continuously learn best practices,” Bartekian says. “After all, it’s not only a project manager who should learn these skills, but everyone in the clinical operations team also,” from the clinical trial assistants to the clinical research associates, and even the document specialists, he adds.
Bartekian expects such thinking will only become more important in time because of the increased emphasis placed on quality management systems and on processes for the proper oversight of sites and vendors, as seen in the most recent E6(R2) update of the International Council for Harmonization’s Guideline for Good Clinical Practice.
Author: Michael Causey