Proof of Concept

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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SMART PROOF OF CONCEPT | PATIENT RECRUITMENT ENROLMENT

Pharmaceutical and Biotechnology companies are increasingly required to gather concise knowledge on the characteristics of a given compound with fewer clinical trials at a much early stage.  This is to reduce the time taken to decide on the continuation on the development strategy.  This is fundamental for both the scientific and economic justifications.

Every year the exploratory clinical trials - be they in healthy volunteers or patients - have become more and more complex.  There is a greater level of design complexity and end points with larger sample sizes.

ARENSIA offers:

  • Dedicated highly experienced team with exceptional reputation in performing sophisticated First-into-Patient trials
  • A unique model of owned hospital-based, modern Exploratory Medicine Units in Eastern Europe with proven fast industry beating patient recruitment achievements/capabilities
  • Tailored Regulatory Strategies

These approaches have greatly benefited our clients as we have reduced timelines, and required resources considerably.  Facilitating the acceleration to PROOF OF CONCEPT

ARENSIA has further reduced time to PROOF OF CONCEPT by using a compact regulatory strategy. This is achieved by using “integrated” protocols.  Specifically by coordinating the activities for First-in-Man studies in healthy volunteers - typically performed by CROs in Western Europe or the US - with First-in-Patient studies performed at ARENSIA units in Eastern Europe.

ARENSIA has successfully contributed to numerous “integrated” protocols in immunology, dermatology, gastroenterology and infectious diseases, for both large pharmaceutical companies and small biotechnology companies.

From established study concepts ARENSIA will help to create a tailored strategy.  ARENSIA can provide fully costed timelines that can include or exclude the “integrated protocol” model.