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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PHASE I RESEARCH CLINICS DEDICATED TO EARLY PATIENT TRIALS

ARENSIA performs complex Phase I/Ib/IIa and PROOF OF CONCEPT trials in eight (8) state-of-the-art research clinics, with full Phase I infrastructure.

Each of the clinics is dedicated entirely to perform exploratory clinical trials in patients. Please scroll the banner above to see images from each of our clinics.

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

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

The following types of studies are performed in ARENSIA´s research clinics:

  • 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

ARENSIA's research clinics are equipped with latest generation clinical pharmacology equipment. 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 research clinics situated within large University Hospitals 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 research clinic
  • 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.

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