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 9 Exploratory Medicine Units, with full Phase I infrastructure at state-of-the-art standards.

ARENSIA´s set up is designed to enable achievement of first efficacy data for novel compounds in record time!

The protocols performed by ARENSIA routinely imply intensive PK sampling, sophisticated PD/biomarker collection (imaging or invasive/biopsies), as well as (long) patient hospitalization or ambulatory visits.

All ARENSIA units are hospital based and entirely dedicated to exploratory clinical trials in patients. Above you can see images from 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
  • Bioequivalence
  • Drug-drug-interaction
  • QTc
  • Phase I PK in Renal & Hepatic Impairment (all stages) vs. matching healthy volunteers

All clinical pharmacology equipment in the units is owned by ARENSIA. The staff working in these exploratory medicine units, e.g. investigators (specialist physicians in various disease areas), nurses, technicians, pharmacists, QA specialists as well as the local project management and recruitment teams are full-time ARENSIA employees with long years of working experience in Phase I/II.

The Principal Investigators in the ARENSIA trials are experts in the field of the given therapeutic area as per protocol, with extensive experience in early phase clinical trials and trained in all ARENSIA systems.

Patient safety is paramount at ARENSIA. With its research units located in university hospitals, the immediate access to first class emergency and intensive care facilities is assured. ARENSIA teams also include specialists trained in emergency care.

ARENSIA´s facilities have close circuit and all follow same Quality Management System / SOPs, with similar set-up:

  • 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: 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.