WE ARE LOOKING FOR STUDY PARTICIPANTS IN THE RHINE-MAIN AREA
Our two institutes always offer studies in various indications for interested patients. If you are interested in participating in one of our studies, please contact us directly or via the contact form for the respective studies, which you can access via the following link. There you will also find further information and the locations where the study is being conducted.
CLINICAL TRIALS
The clinical trials for testing new drugs or therapies are divided into several phases, each with specific goals and requirements.
PHASE 1:
In this first phase, the safety of the drug is tested on a small group of healthy volunteers (usually 20-100). The aim is to determine the tolerability, the optimal dosage and the pharmacokinetics (how the drug works in the body). Side effects are also recorded.
PHASE 2:
This phase includes a larger group of patients (usually 100-300) who suffer from the disease for which the drug was developed. Here, the effectiveness of the drug as well as safety are further investigated. Different dosages are tested to find the one with the best therapeutic effect.
PHASE 3:
In this phase, the drug is tested on an even larger group of patients (often several thousand). The aim is to confirm the efficacy and safety compared to existing treatments or placebo. This phase provides the crucial data required for drug approval.
PHASE 4:
After the drug is approved, it continues to be monitored to assess long-term safety and efficacy. This phase may also include the investigation of rare side effects or the use of the drug in specific populations.
QUALITY IS OF PARTICULAR CONCERN TO US
The Institute for Clinical Research Pneumology is one of the first institutes in Germany to work with a DIN ISO 9001-certified quality management system.
Quality management in medicine according to DIN ISO 9001
refers to the implementation of systematic processes and standards to ensure the quality of medical services and products. DIN ISO 9001 is an internationally recognized standard that defines requirements for an effective quality management system (QMS).
With the TÜV Süd certification certificate for the Scope of application “Execution of clinical studies of Phases I-III”, compliance with the standard regulations is continuously confirmed.
