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a fully integrated and effective platform

Genexion was founded to establish a new standard in clinical development productivity by adopting a high-throughput clinical testing approach. Our clinical development platform fully integrates expertise in basic and preclinical science, product development strategies, enabling technologies and focused clinical research operations. It is particularly well suited for the screening of promising compounds early in development to generate data with high information content and predictive value, and to allow accelerated product development and aggressive portfolio management.

product development expertise

We bring an exceptional center of strategic expertise in the development of new therapeutic paradigms for autoimmune and chronic inflammatory diseases. Our clinical development group is made up of senior clinicians and doctorate level scientists with proven records in the industry. All have experience in bringing new products from preclinical stage through registration in the therapeutic areas Genexion specializes in. As part of our clinical development capabilities we provide:

> Product and Portfolio Assessment, including product potential and positioning, competitiveness and project prioritization.

> Product development strategy formulated by our senior clinical developers, statisticians and Scientific and Medical Advisory Board.

> Product Safety Monitoring including safety profiling, signal optimization for real-time benefit-risk evaluations.

> Registration strategy characterized by a proactive and collaborative approach with regulatory agencies to plan and execute effective strategies early in development.

clinical research operations

We provide clinical research operations built to streamline the development of targeting autoimmune and chronic inflammatory diseases. Solutions are tailored to integrate operational efficiency as well as the marketing requirements of our partners and clients.

With our experience and focus, we can rapidly recommend and deploy operational plans that encompass core study documents, selected networks of investigators, dedicated and specialized staff, experienced data safety monitoring boards, and the appropriate selection of specialized laboratories and vendors.

With our clinical reserach operations, we can manage the complete clinical trial process, including project management, investigator selection, regulatory submissions, site initiation and site monitoring, patient recruitment, safety monitoring, biostatistics and data management, study reporting and medical writing.

development technology

In collaboration with leading institutions, we offer specialized investigations, study modeling and disease read outs that provide additional independent and objective data, increasing the information content and predictive value of early clinical studies. When adequately designed, pharmacodynamic biomarkers can asses initial clinical evaluation beyond classic pharmacokinetics.

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