First Time in Human, Phase I and Proof of Concept

CRO streamlines the whole translational research and First Time in Human to Proof of Concept development process. We embrace quality, while challenging established norms in order to deliver unimaginably efficient solutions. Would you like to explore early signs of efficacy in First Time in Human studies? We make that possible. Do you dare to dream of implementing single-centre solutions for early patient studies? We can do that  too.

Our capabilities cover the whole spectrum of study types, including classical First Time in Human studies, multi-part adaptive design HV/patient studies and Proof of Concept studies. We support the full range of typical Phase I studies, including BA/BEQ, drug-drug interaction, food effect and TQT. We also provide an optimal solution for the conduct of large Phase I biosimilar studies and nutritional intervention trials.

Being ‘Scientifically Driven’ makes us different

What makes CRO  different? First and foremost, an unshakeable belief that our work requires access to the highest levels of clinical expertise and competence. We recruit the very best-qualified medical personnel and support them with the most effective operational approach in the industry.

We seamlessly integrate the expertise and technologies of our clinical and scientific colleagues at Charité – Universitätsmedizin Berlin. This allows us to offer ‘better than niche provider’ levels of competence and capability across the entire spectrum of medicine. We call this our ‘Scientifically Driven’ approach.

Relationship to Charité – Universitätsmedizin Berlin

Our parent organisation is Germany’s largest university hospital: Charité – Universitätsmedizin Berlin. More than 300 years old, Charité is home to some of the most important names in medicine. Now, in the 21st century, Charité is once again at the very cutting-edge of patient care and research. Nowhere is this more apparent than in translational medicine. 

Charité investment in imaging technologies, biomarker laboratory capabilities and research greatly enhances our own capabilities. As a subsidiary, CRO has direct access to Charité’s expertise, technologies and biomarker facilities. You want to make use of these capabilities in early studies? You only need one contract – with us. We will take care of everything.


CRO was founded in 2005, with operations launched in April 2006. It was founded from the belief that the industry would increasingly require a ‘Scientifically Driven’ approach to support translational research and early clinical development. We recognised that the industry would ultimately seek to engage patients and biomarkers in early clinical studies.

We also knew that a new approach would be required to truly facilitate that – enabling studies in patients while maintaining the same efficiency and quality standards traditionally expected in early development. Ultimately, CRO was born from the desire of the Charité to facilitate innovative translational research and early clinical development.