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What is Driving Change
Industry is seeking new and different ways to conduct clinical studies as complexity increases, costs continue to rise, and success rates decline. At the same time, industry is challenged by a critical shortage of monitors and seems poised to respond by moving toward hiring practices that favor competence over experience requirements. These factors combined have created a need to standardize expectations and performance standards related to monitoring activities.
Where You Can Expect Change
Expect increased utilization of technology to streamline and accelerate study conduct. Professionals involved with or impacted by monitoring activities should anticipate greater focus on data considered most critical to studies and increase utilization of electronic data, case report form software, “The Internet of Things,” mobile tech, and risk mitigation tools. The future of monitoring will also require significant change in relationships between research partners, particularly the relationships between staff at study sites and sponsors/contract research organizations.