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CCBR Phase 1 Capability

CCBR partners with C4Pain (a research based CRU, based in Aalborg, Denmark) for Phase I studies. C4Pain is the only research based international CRU focusing entirely on pain and inflammation. C4Pain delivers the most advanced and comprehensive pain mechanism based targeted drug profiling program within pain and inflammation. C4Pain utilizes validated translational human pain bio-markers for fast and efficient proof-of-concept and proof-of-mechanism target validation of new and existing compounds for the treatment of pain. CCBR built the Phase I Unit to focus on Proof of Concept studies within pain and inflammation CCBR’s Phase I unit is also suitable for other Phase I Clinical Trials including single- and multi-dose PK studies.

 

Experimental pain models

  • Controlled non-traumatizing painful stimulus

  • Long term stability

  • Activation of specific nerve fiber populations

  • Activation of specific tissues

  • Activation of specific mechanisms

  • Correlation to bio-markers (e.g. inflammatory mediators)

  • Multidimensional assessment regimes (psychophysics, electrophysiology, imaging, biochemical)

  • Surrogate models for selected clinical symptoms

 

Surrogate pain models can mimic: 

  • Hyperalgesia - skin, muscle, viscera

  • Receptor sensitization – different modalities

    • Primary hyperalgesia

    • Inflammatory model

    • Microdialysis

  • Central sensitization – different modalities

    • Secondary hyperalgesia

    • Allodynia

  • Summation – skin, muscle, viscera

    • Temporal summation – different modalities

    • Spatial summation – different modalities

  • Descending control – skin, muscle, viscera

    • Diffuse noxious inhibitory control

 

 

 

 

 

 

Benefits of the CCBR Model

  • Working with CCBR speeds up and drives efficiencies in clinical trials by offering greater numbers of patients across fewer sites

  • A Global Footprint covering more than 20 dedicated Clinical Research Centers in high density population areas

  • Uniform SOPs enable the tightest possible adherence to study protocols and consistency across all CCBR sites

  • Real-Time tacking of subject enrolment and trial progress ensures sponsors have the most up to date information, all of the time

  • Centralised, standardised billing affords better visibility into trial costs for sponsors

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