RESEARCH CLINICS DEDICATED TO EARLY PATIENT TRIALS

Types of studies 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/Food-Interaction
• QT/Thorough QT
• Phase I PK in Renal & Hepatic Impairment (all stages)

Exceptionally skilled personnel

We employ our own investigators (specialist physicians in various disease areas), nurses, technicians, pharmacists, quality assurance specialists, local project managers/site coordinators, and recruitment teams.

ARENSIA’s medical/investigator teams are complemented by Principal Investigators (PIs) and Sub-Investigators who are the leading specialists in each protocol-related indication and bring strong medical expertise to a trial.

We 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.

Our personnel is specialized in processing and shipping PK/PD/Biomarker samples to local & central labs anywhere in the world.

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

All clinics, one standard!

All ARENSIA clinics follow a unified standard Quality Management System / SOPs:

• Between 4 and 25 intensive monitoring beds per research clinic
• On-site ICU and Pharmacy
• Modern clinical pharmacology equipment: ECGs, BP monitors, centrifuges, synchronized clocks, crash cart, defibrillator, freezers (-20/-80), liquid nitrogen storage
• PBMC isolation/preparation

ARENSIA has access to state-of-the-art diagnostics technologies at each location (on- site or at selected vendors in the vicinity of our research clinics), including full range of imaging for all therapeutic areas (MRI, PET, SPECT-CT, ultrasound) as well as invasive procedures/tissue sampling (biopsies) etc.