Product/Service

Clinical Pharmacology

Source: ICON

Translational Medicine

The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.

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The clinical pharmacology team at ICON Development Solutions has extensive experience in the design, implementation and interpretation of clinical pharmacology studies in all major therapeutic areas.

ICON’s Preclinical consultancy services determine potential surrogate markers and models; validation of surrogate markers and models; development of flexible protocol design. We offer clear thinking to help make critical development decisions quickly.

Implementation
Once the correct study design has been agreed there is rapid transfer and startup of the clinical phase. We undertake First in Man (FIM) studies, on average taking one new chemical entity into man every month.

ICON has experience implementing:

  •  First-in-Human, dose escalation studies
  •  Drug interaction studies
  •  Special population studies (pediatric PK, elderly, renal-impaired, hepatic-impaired)
  •  Thorough QTc studies
  •  Dose proportionality
  •  Multi-dose PK and/or PKPD
  •  Age/Gender/Race
  •  Food effect studies
  •  Relative bioavailability (including formulation bioequivalence)
  •  Absolute bioavailability
  •  Dosage regimen assessments
  •  Pharmacodynamic studies

Our Key Phase I services include:

  •  Regulatory Affairs
  •  PK/PD Modeling and Simulation
  •  Pharmacodynamic Models
  •  Data Analysis
  •  Bioanalytical laboratory services
  •  Subject Recruitment
  •  Medical Writing
  •  Publishing
  •  Quality Control Assurance
     

Cllinical Pharmacology Units

 San Antonio, TX, USA

  • 110 beds
  • In-house CLIA/COLA certified, clinical laboratory providing hematology, coagulation, platelet aggregation, chemistry, drug testing, urinalysis
  • Full cardiac monitoring and assessment via 32-channel telemetry, digital multiple/serial central ECGs, continuous 12-lead Holter monitors, core ECG Data Storage - ideal for tQTC studies
  • Pulmonary function and exercise stress testing
  • On-site pharmacy with Bio hood
  • On-site PK processing laboratory
  • Central IRB

Omaha, Nebraska, USA

  • 80-140 beds
  • Purpose-designed clinical research facility
  • Experienced Phase I Clinical Research Staff
  • On-site pharmacy with Bio hood
  • On-site PK processing laboratory
  • Crash Carts & ACLS certified staff 

Manchester, UK

  • 34 beds
  • Hospital-based clinical research facilities at the Manchester Royal Infirmary
  • Extensive and fully validated pharmacodynamic models in cardiovascular, CNS and metabolic diseases
  • Local pharmacy support
  • Local bioanalytical support
  • Human performance and tissue handling laboratories
  • Pharmacodynamic study testing suites that are sound-proofed, temperature & light-controlled and air-managed
  • MHRA Supplementary Accredited