Pharmacodynamic (PD) models and specific trial designs at CRS

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) 

 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

• Phototoxicity and photosensitization of topically or systemically administered drugs

Renal Insufficiency / Hepatic Insufficiency

• Hepatitis 1-2 trials per year

• Hepatic cirrhosis 5-6 trials per year – clinical duration 4-6 months

• Renal insufficiency 6-8 trials per year – clinical duration 3-6 months

• Dialysed patients 2 trials per year – clinical duration 2-4 months

Therapeutic Trials

• Patient panels in various therapeutic areas

• Symptom bearing subjects

• Parallel recruitment in three clinics

Ambulatory Trials

• Capacity for more than 300 subjects daily

Longterm Trials

• Experience with confinement for up to 53 inhouse days

Large Trials

• Large 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