Bucharest
Moldova
Tbilisi
Kiev

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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EXPLORATORY MEDICINE UNITS

ARENSIA performs complex Phase I/Ib/IIa and PROOF OF CONCEPT trials in nine (9) state of the art Exploratory Medicine Units

ARENSIA facilities offer the fastest unparalleled first efficacy data for compounds

ARENSIA routinely manage protocols with intensive PK sampling, sophisticated PD/biomarker collection (imaging or invasive/biopsies), as well as (long) patient hospitalisation or ambulatory visits.

All ARENSIA units are located within prestigious University hospitals in Romania, Republic of Moldova, Georgia, and Ukraine.   Each of the units is dedicated entirely for exploratory clinical trials in patients.  Please scroll the banner above to see images from each of our units.

locations
NUMBER OF UNITS- each based in large hospitals -
LOCATION
THERAPEUTIC AREAS SERVED
4 Exploratory Medicine Units
Bucharest, Romania
Immuno-inflammatory, oncology, pulmonology, cardiology, metabolic/diabetes, nephrology, gastroenterology, dermatology, infectious diseases (HCV/HBV/HIV), neurology, selected pediatrics
3 Exploratory Medicine Units
Chisinau, Moldova
Immuno-inflammatory, oncology/hematology, metabolic/diabetes, cardiology, gastroenterology, urology, nephrology, dermatology, ophthalmology, hepatology, infectious diseases (HCV/HBV), psychiatry, neurology
1 Exploratory Medicine Unit
Tbilisi, Georgia
Onology/hematology, immuno-inflammatory, dermatology, gastroenterology, cardiology/metabolic, gynecology, gastroenterology, infectious diseases (HBV/HIV), neurology
1 Exploratory Medicine Unit
Kiev, Ukraine
Oncology/hematology, immuno-inflammatory, dermatology, gastroenterology, infectious diseases (HCV/HBV), metabolic/diabetes, cardiology, gynecology, urology, ophthalmology, neurology

The following types of studies are performed in the ARENSIA exploratory medicine units:

  • First-in-Patients SAD/MAD adaptive design: safety, efficacy, dose finding
  • PROOF OF CONCEPT
  • Bioavailability/Bioequivalence
  • Biosimilars
  • Drug-Drug-Interaction
  • QT/Thorough QT
  • Phase I PK in Renal & Hepatic Impairment (all stages) vs. matching healthy volunteers

All clinical pharmacology equipment in the units is owned by ARENSIA.  ARENSIA employs its own investigators (specialist physicians in various disease areas), nurses, technicians, pharmacists, quality assurance specialists, local project managers, and recruitment teams.  All our staff have years of experience in Phase I/II studies and support.

The Principal Investigators in ARENSIA supported trials are experts in the fields of the given therapeutic area/indications. They all have extensive experience in safely conducting early phase clinical trials with training on all ARENSIA systems.

Patient safety is of paramount importance at ARENSIA.  Having the units situated within the University Hospital gives immediate access to first class emergency and intensive care facilities.  ARENSIA and hospital support teams are fully trained in the emergency procedures.  

ARENSIA facilities have a unified standard Quality Management System / SOPs:

  • Between 4 and 20 intensive monitoring beds per unit
  • On-site pharmacy/laminar flow
  • On-site nutritionist
  • Intensive care units within the hospitals
  • Modern clinical pharmacology equipment: ECGs, BP monitors, centrifuges, synchronized clocks, crash cart, defibrillator, freezers (-20/-80)
  • PBMC isolation/preparation
  • Liquid nitrogen storage

ARENSIA has access to state-of-the-art diagnostics technologies at each location, including; MRI, SPECT-CT, echocardiography, left/right heart catheter, angiography, arthroscopy, exercise and challenge testing, endoscopy (digestive, urologic, fibroscopy), fibroscan, complex respiratory function testing (serial spirometry, exercise testing, body plethysmograph measurements, sputum induction and processing, bronchoscopies, broncho-alveolar lavage, biopsies), invasive diagnostics/tissue sampling (biopsies), etc.  Other protocol required equipment can be accessed on a case by case basis.