Profile

Clinical Research UnitProfile

The Clinical Research Unit is performing clinical studies based on Good Clinical Practice (ICH GCP V) and is DIN ISO 9001 certified. We are specialized in proof of concept phase I-IV clinical studies. 

REPERTOIRE OF STUDY DESIGNS
•   Clinical controlled studies
•   Observational studies (cohort, case-control, prevalence, incidence)
•   Instrument/score development and/or validation
•   Secondary data analyses
•   Systematic reviews and meta-analyses
•   Pharmacokinetic studies
•   Experimental laboratory studies

GENERAL SCIENTIFIC SERVICES 
•   Scientific and clinical consultation and support
•   Statistical consultation including sample size determination
•   Study protocol development
•   Literature reviews
•   Medical writing
•   Manuscript preparation, submission and follow up
•   Scientific presentations

CLINICAL STUDY PERFORMANCE
•   Completion of regulatory procedures including submissions to responsible ethics committees
•   Planning of recruitment strategies
•   Management and coordination of all study related tasks
•   Recruitment
•   Drug accountability and storage in conditioned  
•   Temperature logged rooms
•   Working according to Standard Operating Procedures (SOPs)
•   Data management including Case Report Form (CRF) development
•   Monitoring
•   Statistical analysis and study reporting
•   Manuscript preparation and submission to international peer-review journals