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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COVID-19 RESEARCH

COVID-19 RESEARCH

ARENSIA has contributed to numerous research projects with innovative compounds enrolling more than 1,500 COVID-19 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 own state-of-the-art research clinics
  • Project Management/Study Coordination
  • 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 the leading Pharmaceutical companies worldwide, as well as with numerous Biotechnology companies.

Global and Mid-sized full-service Clinical Research Organizations also often utilize ARENSIA's services to conduct early phase patient clinical trials. This approach allows sponsors that are bound by global outsourcing agreements with selected full-service CRO vendors to use 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.

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