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Proof of concept trials

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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Quick look behind the doors of ARENSIA´s pharmacies

HOME · NEWS · QUICK LOOK BEHIND THE DOORS OF ARENSIA´S PHARMACIES

ARENSIA has integrated pharmacies located within each of their Research Clinics. The pharmacies have been commissioned exclusively for the preparation, storage and dispensing of investigational medicinal products (IMP) for clinical trials in compliance with GMP guidelines.

Quick look behind the doors of ARENSIA´s pharmacies: 

  • Strict, secure, controlled access to the integrated pharmacies within each Research Clinic.
  • Continuously monitored full temperature controlled environments with logs and systems in place for per minute analysis.
  • All ARENSIA’s on-site pharmacies have identical infrastructures with laminar flow cabinets, fridges, freezers, secure storage spaces with dedicated areas for documentation and electronic systems.
  • Isolated quarantine space.
  • Experienced IMP managers and clinical pharmacologists covering the preparation of various forms: dispensation of oral IMP from bulk, preparation of solutions for oral use that require strict dosing time, preparations for subcutaneous and intravenous administration.
  • Harmonized collaborations between IMP managers, Investigators, Site Coordinators for monthly, weekly and daily visit planning, dosing planning, per study analysis of source documents between all ARSENIA’s research clinics.
  • Established process for IMP compliance with 3 x “double checks” after preparation, upon dispensing to the Investigator and prior to dispensing to trial participants. 
  • Efficient, high quality systems in place for IMP management across all ARENSIA’s research clinics that can be seamlessly combined with Sponsor’s systems.
  • Our pharmacies are available 24/7 to cover all IMP requirements as determined by the clinical trial protocols, including specific dosing timing.
  • Precise IMP reconciliation, destruction, return or retention processes and records in place. 
10.03.2020
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