With more than 30 years of experience in Clinical Pharmacology we are specialised in:

Cardiovascular
• 24 hours ECG holter monitoring & recording
• 24 hours ambulatory blood pressure
• Impedance cardiography
• Pulse wave velocity, augmentation index

QTc Trials
• According to ICH E 14
• Various study designs and different ECG service providers
• ECG recording using holter technique or stationary triplicates
• Large trials – up to 200 subjects

Controlled Drugs
• Experience with special narcotic drug trial designs (e.g. naltrexone blocking)
   in accordance with ethical and legal requirements
• Permission to deal with narcotic substances
• In-house board certified anesthesiologists in two locations

First in Man (FIM)
• Large intensive monitoring capabilities
• Intensive care units (ICU) in close proximity
• Design adaptations to sponsors’ and authorities’ requirements
• Experience in FIM submission to BfArM
• Online bioanalytics (i.e. for dose escalation discussions)

Pharmacodynamic Techniques

Respiratory
• Pulmonary function testing
• Digital spirometry & body plethysmography
• Spiroergometry
• Induced sputum, nasal provocation & lavage

Gastrointestinal
• Intragastric 24h pH-metry
• Continuous telemetric core body temperature Psychometric Testing
• Cognition & Vigilance testing (Vienna Determination Test System, CDR), validated questionnaires, Visual Analogue Scales,
  computerized pupillometry (static and dynamic)

Skin Safety
• Irritation, sensitization of topicals and transdermal application systems

Therapeutic Trials
• Patient panels in various therapeutic areas
• Symptom bearing subjects
• Large ambulatory Trials
• Longterm Trials
• Experience with confinement for up to 53 inhouse days

Large Trials
• Large confinement trials with high sample sizes of n=200 or more (e.g. PK trials, QTc Trials)
• The conduct of large-scale trials can be accelerated by integrating all three clinics into
   one project with parallel recruitment in three urban areas