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Proof of concept trials

PROOF OF CONCEPT TRIALS

proof of concept trials

ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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PHASE I SPECIAL POPULATIONS

phase i special populations

ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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REGULATORY PROCESS

regulatory process

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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WHY EASTERN EUROPE?

ARENSIA locations in Eastern Europe offer the following features to the pharmaceutical sponsors:

  • Access to large patient pools
  • Well documented medical records
  • Experienced, world-class physicians
  • Modern diagnostics/imaging technology
  • No issues regarding IP protection
  • Competitive regulatory environment
  • EU legislative environment
  • Long experience in the clinical research business

Regulatory authorities are supportive of adaptive trial designs which allow to modify doses, treatment regimens, in order to receive first efficacy results as early as possible.