Clinical Researcher

Instead of coming to market with relative ease, many digital therapeutics have been mired in processes that were originally designed for more traditional therapeutics, such as drugs.

In theory, dose optimization is a relatively simple concept—make sure a drug’s dose delivers the best balance between risk and benefit for the patient—yet in practice it is a different story.

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.