Studies & Collaborations

Access to a unique patient collective from over 190 nationalities from the metropolitan area of Berlin, and the possibility of recruiting patients for performance studies.
Dedicated spaces for joint developments that ensure short pathways and efficient sample processing.
Close networking with clinics and faculties on the Charité Campus of the Virchow Clinic.

We offer optimal conditions, even for handling time-critical samples, such as in stability studies. Benefit from:

our extensive experience with IVD-specific guidelines
our comprehensive expertise in study design
interdisciplinary teams & diagnostics in 10 different departments
our innovative work environment that facilitates development for the benefit of patients

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Prototype testing
Contract analysis
Support in study design
Coordination with the study sites

Evaluations and validations
Development of reference methods (Reference Method Procedure)
Development of mass spectrometric methods

Method comparisons
Real world data for benchmarking and product design support

Specialized laboratory personnel for studies
Dedicated quality management specialist

Dedicated laboratory spaces with varied confidentiality levels provide a secure study environment where device prototypes can also be set up with restricted access.

Additionally, the systems in other areas of expertise and in the central routine laboratory can be utilized.

Chemiluminescence Immunoassay (CMIA)
Nephelometry
Turbidimetry
Enzyme-linked Immunosorbent Assay (ELISA)
Flow Cytometry (FACS)
Fluorescence In Situ Hybridization (FISH)
Liquid/gas Chromatography (LC/GC)
Liquid/gas Chromatography with Mass Spectrometry Coupling (LC/GC-MS)

High-pressure and ultra-high-pressure liquid chromatography (HPLC)
Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Matrix-Assisted Laser Desorption/Ionization with Time-of-Flight Analysis (MALDI-TOF MS)
PCR
Multiplex PCR
Quantitative Real-Time PCR (qPCR)
Next Generation Sequencing (NGS)

Studies

Our parent companies Charité and Vivantes work with thousands of scientists and doctors on pioneering developments in medical research. Consequently, Charité Berlin, as a university hospital, conducts numerous studies. Acting as an interface between laboratory diagnostics and the clinic, we deliver various diagnostic parameters to support researchers investigating scientific hypotheses.
As an interface between laboratory diagnostics and the clinic, our department supports researchers with scientific questions on the determination of various parameters.

For specific contract analyses feel free to browse our services directory.

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Collaborations

We have long-standing experience in collaborating with the top players from the in-vitro diagnostics and pharmaceutical industries.
Our team is specialized in the planning, execution, and documentation of studies. It possesses extensive knowledge of the regulations according to AMG/CTR and MPDG/IVDR.
The international ethical and scientific quality standard “Good Clinical Practice (GCP)” according to DIN EN ISO 20916 or ICH GCP E6 is a given for us.
Due to the recently introduced IVDR 2017/746 requirements, the need for performance studies and market surveillance studies has increased. We are convinced that the development of new in-vitro diagnostics will be significantly improved by early feedback from intended users in the laboratory environment and access to clinical samples.