Phase I

Helping you efficiently transition from First Time in Human to Proof of Concept

Charité Research Organisation focuses on supporting your early clinical development needs. Our aim is to help you transition your product from First Time in Human to Proof of Concept as efficiently and quickly as possible. The labels applied vary a little from company to company, but broadly speaking this means we are undertaking the first studies in humans, ‘typical’ Phase I type studies and ‘classical’ Phase IIa or even full Phase II studies. We are able to bring patients into the very first studies, in addition to healthy volunteers.

Charité Research Organisation has a wealth of experience in the efficient conduct of typical Phase I studies in healthy volunteers and patients. This includes the conduct of single and multiple dose PK/PD studies, food effect studies, BA/BEQ studies, drug-drug interaction studies, TQT studies and many more. We also specialise in the conduct of Phase I studies enrolling hundreds of subjects typical for biosimilar trials and nutritional intervention trials. You want to conduct a Phase I biosimilar study in n=210 healthy volunteers? We can do that.

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Scientific Expertise

Operational Excellence

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Development Phases

Helping you efficiently transition from First Time in Human to Proof of Concept

Phase I