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emovis conducts phase I to IV studies.
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.
Phase II – Determining the dose-corresponding effect
The effect of an active ingredient is tested on several hundred patients in the defined indication segment in Phase II. The most exciting aspect for the emovis team in Phase II is typically the insight in the first application on patients. Patients that have completed a therapy segment are especially motivated for trial II. In part, they hope to participate in a later phase again.
Phase III – Better than placebo or standard therapy?
In Phase III the strict effect verification compared to placebo or a standard therapy is implemented. Clinical trials in this phase are usually randomized and if possible, double-blind. These clinical trials include up to several thousand patients. The especially exciting aspect for emovis in Phase III clinical trials is in part, to participate in an (often) worldwide implemented project and to contribute to the success with all of its commitment and expertise.
If it is a blinded trial, emovis is of course more than adequately equipped to break the code if necessary in the event of a AEs or SAEs. The "medical emergency telephone” is available for cases like this. More specifically: a clinical investigator is on duty and is able to break the code according to the applicable SOP.
Phase IV – Are there still unknown side effects?
Phase IV accommodates the exam, reliability and effect. Drugs that have already been approved are undergoing additional assessments and the determination of potential rare side effects is an important goal. The interesting aspect for emovis in conducting a Phase IV trial is primarily the recruiting process. The willingness of patients to participate in a trial for an approved drug is especially great.