THOUGHT LEADERSHIP

Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.

In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.

Related, Not Related, Likely, Possibly Related, Unlikely Related, Certain, Definitely, Unassessable, Unknown, Probably Related…if you recognize these terms, then there is a reasonable possibility you are familiar with what the Drug Safety and Pharmacovigilance world refers to as the causality assessment.

I was in New York City on March 1, 2020 when the news reported that the first positive case of COVID-19 had been identified in that state. A pharmaceutical company seeking accelerated approval for one of their products had selected PROMETRIKA to re-monitor their study’s efficacy data after a recommendation from the European Medicines Agency. I ended up traveling to NYC on short notice after learning about an urgent need for a monitoring visit at one of the oldest and largest teaching hospitals in the United States. While leading a two-day monitoring visit at that hospital, it was announced that a coronavirus patient had been admitted to their emergency room for the first time. The research staff in my vicinity were anxious about this invisible, contagious, mystery virus, and it had just been confirmed that their colleagues were interacting with a patient that had been exposed to it. I walked back to the hotel that night and didn’t think anything of it when the song, “The Only Living Boy in New York” came up at random on my playlist.