Early Development Phases of Phase I and Ib

Phase I of clinical research is currently undergoing changes. In addition to healthy study subjects, patients are integrated in the early development phases of drugs more frequently. This correlation is defined as “adaptive designs“. The underlying reason is to potentially decrease the timeframe between the initial administration to humans (first time in human) and the proof of concept. This is where emovis becomes active. As a study site with such a valuable combination of 1. competence and "Dedication" as well as 2. the ability to recruit a high number of patients in a high-quality, diligent and fast manner.  

Phase I – Pharmacokinetic and Pharmacodynamics

"What does the body do with the substance?" and "what does the substance do to the body”; that and the tolerability are questions assessed by the clinical drug inspection in Phase I. The professional sector refers to the first case as "Pharmacokinetic" and in the second case as "Pharmacodynamics". Generally 80 to 100 healthy patients are enough to answer these questions; however, individual patients with relevant indications are included more frequently as well.

Ward "Sleep laboratory" – Located in a Comfortable Atmosphere

In all honesty, it can be said that the sleep disorder laboratory has been furnished without consideration of the Phases I und Ib. Sleep disorder trial, such as insomnia, restless leg syndrome, migraine and depression are, and have been the common business practice on the 4th floor at emovis. However, these projects can be put on hold to accommodate the implementation of an interesting Phase Ib study, because the emovis sleep disorder laboratory is transformed into a “ward” for these projects. Up to three study subjects are admitted and quartered on an inpatient basis. In comfortable surroundings, the study subjects reside there for the duration of the trial and may only move under supervision for walks around the district surrounding the study site.