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:

  • Performance of Phase I/ II/ PROOF OF CONCEPT trials, in patients, in its own Exploratory Medicine Units
  • Project Management
  • Regulatory Affairs (dossier preparation and submission to HA/EC, import/export of study medication, etc.)
  • Scientific advice within protocol development (on medical/in-exclusion criteria, study design as well as logistics aspects)
  • Quality assurance (stand-alone QA  service)

Medical writing, data management, biostatistics, central laboratory and bio-analytical services can be offered via qualified vendors.

ARENSIA collaborates with the majority of top 20 international pharma companies, as well as with various biotech companies.

ARENSIA also collaborates with global and mid-size full service CROs, which sub-contract to ARENSIA the conduct of the early phase clinical trials requiring patients. Like this, some Sponsors which are bound by global outsourcing agreements do not refrain from following such agreements, while using ARENSIA´s expertise and speed.

By involving ARENSIA, our Sponsors are considerably reducing the recruitment time, while the number of involved sites/countries can be reduced as well. This translates into major cost savings at overall project level.