FOCUS Clinical Drug Development - Exploratory Drug Development of NCEs / NBEs

FOCUS Clinical Drug Development is an independent full-service CRO specialised in early clinical development and integrated proof of concept (PoC) packages. FOCUS has conducted more than 600 high-quality early-phase clinical studies in healthy volunteers and many patient populations.

Core indications are neuroscience, cardiovascular and metabolism and immunology/oncology. We provide our clients with clinical research expertise and global drug development knowledge, as well as strategic advice and scientific consultancy.

Clinical pharmacology and exploratory drug development

FOCUS offers a unique combination of drug development and clinical pharmacology / exploratory drug development know-how, plus an infrastructure to manage complicated clinical studies with chemical drugs, biologicals and vaccines in expedited timelines with a high standard of quality. FOCUS has been audited five times by the US FDA.

FOCUS has 120 experienced and dedicated employees. We support many different exploratory development study designs and activities, including:

Study designs:

• First in human studies
• Translational medicine / exploratory CTA
• Biomarker / imaging studies / fMRI / PET in animal and man
• PoC packages
• Efficacy / dose finding studies
• Drug – drug interaction studies
• Biologicals and vaccine development
• Ethnobridging studies (Caucasian / Japanese / Asian / African)
• Bioequivalence / bioavailability / PK
• QTc studies, EEG studies and special safety studies

FOCUS activities:

• Protocol writing and CRF
• Regulatory support
• Scientific advice
• Pharmacy / CTS management
• Study conduct
• Biomarker and immunology lab
• Bioanalytics and PK, assay development
• Central clinical laboratory and pharmacogenomics testing
• Data management / biostatistics
• Quality assurance

FOCUS Clinical Drug Development GmbH
Stresemannallee 6
41460 Neuss
Germany

Tel: +49 2131 1550
businessdevelopment@focus-cdd.de
www.focus-cdd.de
www.focus-immunology.com
www.focus-biomarker.com