Tests according to AMG

Each clinical trial is unique.

Clinical trials are medical research procedures involving human subjects. They are conducted with human subjects or patients to evaluate the safety and efficacy of a suitable drug.

It is a highly regulated, lengthy, risky and time-consuming process that requires precision and multidisciplinary professionalism.

Preclinical studies

The development of an effective and low-risk drug from discovery to market launch is a labor-intensive process lasting several years. It begins with preclinical tests in the laboratory in vitro and in vivo.

After a substance has been demonstrated to be safe, the Common Technical Document (CTD) must be developed in accordance with the International Conference on Harmonization (ICH). This is a mandatory step in the drug development process before a human clinical trial can even begin. The CTD consists of 5 modules that contain detailed information on the formulation and pharmaceutical grade to the results of in vitro and in vivo efficacy testing, toxicity studies, pharmacokinetics, bioavailability and potential hazards to the environment.

Only after the European Commission has approved the document can a Phase I clinical trial begin under the German Medicines Act (AMG).

Every preclinical study is unique, just like every product. We at MEDIACC and our partners will help you finalize your documentation and communicate with the relevant authorities to start your study while you can focus on the development of your product.

Shorten the time until the first subjects receive your product at rounds and give us a call.

Clinical research studies are divided into four (or five) phases (Phase (0) I-IV) depending on the type of drug. The next (subsequent) phase of the clinical trial cannot begin until the previous one has demonstrated safety and efficacy of the drug.

Phase 0 Tests drug safety in humans.

Phase I Captures the maximum safe dose of the investigational drug in healthy humans.

Phase II patients receive the investigational drug for the first time (testing for safety and efficacy).

Phase III Compares test drug with established standard treatment in patients.

Phase IV Tests efficacy and safety over a long period of time in a large number of patients.

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