With new regulatory deadlines looming in the EU, it became clear that there would not be sufficient capacity to maintain existing medical devices and IVDs on the market and bring new ones to the public without a change of plans.
Offering up a variety of perspectives on ways to improve, broaden, and deepen the business aspects of the clinical research enterprise for the benefit of all its stakeholders.
Even as decentralized clinical trials become more prevalent, the vexing issue of retaining participants throughout the course of a trial will continue to be problematic without a thoughtful approach to keep them engaged.
Institutional review boards are often seen as a barrier to paying participants in clinical research, but thinking on this topic has evolved significantly during the past few years.
Despite the huge advances we have witnessed in recent years, one of the biggest barriers to technology-driven decentralized clinical trial adoption remains a lack of agreed standards for compliance and ethics.