Services

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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SERVICES

ARENSIA offers the following services:

  • Conducting Phase I/ II/ PROOF OF CONCEPT patient trials, in state of the art fully owned Exploratory Medicine Units
  • Project Management
  • Regulatory Affairs (dossier preparation and submission to HA/EC, import/export of study medication etc.)
  • Scientific advice for protocol development (Therapeutic/indication medical considerations on all aspects of protocol development from inclusion/exclusion criteria, study design to logistical aspects etc.)
  • GCP - Auditing (stand-alone Quality Assurance service)

Other services via qualified vendors for medical writing, data management, biostatistics, central laboratory and bio-analytical services can also be arranged.

ARENSIA collaborates with most of World’s Top 20 Pharmaceutical companies, and numerous Biotechnology companies.

Global and Mid-sized full-service Clinical Research Organisations also often utilise ARENSIA services to conduct early phase patient clinical trials.  This approach does not cause any issues with some sponsors that are bound by global outsourcing agreements while using ARENSIA’s expertise and speed.

By involving ARENSIA, our clients have considerably benefited in reducing recruitment periods, and the overall number of involved sites/countries in a range of studies.  This translates into major financial savings for the total project lifecycle.