PHASE I RESEARCH CLINICS DEDICATED TO EARLY PATIENT TRIALS
ARENSIA performs complex early patient trials - Phase I/Ib/IIa and PROOF OF CONCEPT - in twelve (12) state-of-the-art research clinics, with full Phase I infrastructure.
Each of ARENSIA´s research 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.
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/site coordinators, and recruitment teams.
All ARENSIA staff has long years of experience in performing complex Phase I/II studies (first-in-patient/adaptive protocol design) with novel compounds across a vast range of patient populations.
ARENSIA’s medical/investigator teams are complemented by Principal Investigators (PIs) and Sub-Investigators who are the leading specialists in a given indication and bring strong medical expertise to a trial. They all have extensive experience in clinical research with international recognition and acknowledgments. ARENSIA´s PIs work as chief physicians/clinicians at the hospitals in which ARENSIA’s clinics are co-located and collaborate with ARENSIA on a part-time basis. They all have substantial experience in safely conducting early phase clinical trials with training on all ARENSIA systems and SOPs. We ensure continuity and quality by having the same specialist PI for all trials in the given indication/therapeutic area.
ARENSIA’s medical teams routinely manage protocols with intensive PK sampling, sophisticated PD/biomarker collection (imaging or invasive/biopsies), PBMC technique, as well as (long-term) patient hospitalization and/or ambulatory visits.
Specifically, the ARENSIA study nurses and technicians are well trained in processing and shipping of PK/PD samples, biomarkers, etc. to central labs or local labs: blood, urine, tissue (incl. arrangements with specific curriers) to EU within 24 -36 h; to USA within 48 h.
Patient safety is of paramount importance at ARENSIA. Having the 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.
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 (on-site or at selected vendors in the vicinity of our research clinics), 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.
