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 research clinics 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 renal or hepatic insufficiency
  • 1 to 2 patients per week with severe renal insufficiency
  • 1 patient per 6 to 8 weeks with severe hepatic 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.

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