Phase I special populations

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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PHASE I TRIALS IN SPECIAL PATIENT POPULATIONS

ARENSIA offers exceptional fast recruitment rates in Phase I trials requiring renal and hepatic impaired patients. Our units have extensive expertise with various designs of such trials, involving intensive PK sampling and hospitalization.

We access following pools of patients:

  • over 2.000 patients with hepatic impairment Child Pugh A, B and C
  • over 3.000 patients with mild, moderate, severe renal impairment (incl. End Stage Renal Disease patients: with or without dialysis).

The typical recruitment rates for a Phase I trial with either renal or hepatic impaired patients are as follows:

  • 2 to 4 patients per week with mild and moderate insufficiency
  • 1 to 2 patients per week with severe insufficiency

We also access oncology patients with renal/hepatic impairment. We recruit the healthy subjects as control group.

Based on a concrete study concept we are glad to offer detailed feasibility, incl. the related estimated budget and timelines.