Harrison Clinical Research | Harrisonclinical - clinical pharmacology unit phase i iia

By: Harrison Clinical Research  09-12-2011
Keywords: clinical research, Cpu, food science

The Clinical Pharmacology Unit (CPU) of Harrison Clinical Research has 6 intensive care beds and 30 beds for short-term stays (several days), of which 18 can be used for long-term stays (several weeks).

The unit performs state-of-the-art services in Phase I-IIa, from first administration to man, pharmacokinetics/pharmacodynamics, bioequivalence, special population and efficacy studies through to large out-patient  studies, for example, vaccination studies and food science studies.

We have a database of about 15,000 male and female normal, healthy volunteers (18 - 80 plus years of age) and also patients with specific conditions, thus enabling us to recruit either volunteers or patients, for your study, very quickly. See Volunteer and Patient Database flyer, to the right of this page.

Our CPU is:

  • Professionally staffed
  • Well equipped
  • Highly skilled
  • With long experience
  • Ready to take on the most pivotal parts of your project

Our Munich clinic offers:

  • First administration in man to proof of concept studies
  • Single or multiple dose tolerance studies
  • Interaction studies (drug-drug, drug-food and other interactions)
  • Pharmacokinetics, pharmacodynamics
  • Bioequivalence studies
  • QT studies
  • Special population studies (elderly, post menopausal women, various chronic dieases)
  • Large outpatient studies (vaccination, food science, smoking)

Over the years the clinical pharmacology unit (CPU) has gained considerable expertise and an excellent reputation for scientific and medical expertise and for clinical results and is fully ICH-GCP compliant. It is close to several large hospitals and university clinics and can be readily accessed by clients by air, rail or road. It is efficiently served by public transportation allowing easy access for volunteers. It also has its own recruitment and free-call centre.

There are established cooperations with practising specialists in:

  • Cardiology
  • Diabetology
  • Dermatology
  • Orthopaedics/
  • Nephrology
  • Endocrinology
  • Immunology
  • Pneumology
  • Ophthalmology
  • Gastroenterology
  • Neurology/Psychiatry
  • Gynaecology
  • Radiology/
    Nuclear Medicine

We also have substantial expertise in studies using various medical devices and diagnostic kits.

The CPU is well versed in electronic data capture and eCRF and eDiary systems either provided by sponsors or by Harrison Clinical Research. Similarly, we have our own standard operating procedures (SOPs), investigator file format and forms but we can adapt our procedures and forms to sponsors SOPs, when requested.

The CPU has an association with a modern, comprehensively equipped bioanalytical laboratory, offering:

  • Methodological development and validation
  • Quantification of drugs and metabolites in biological matrices
  • Enantiomer selective detection
  • Preparation of bioanalytical reports
  • GMP analysis of raw materials, final products, stability tests, dissolution tests

Keywords: Clinical Pharmacology Unit, clinical research, Cpu, food science,

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