PROOF OF CONCEPT CLINICAL TRIALS
Pharmaceutical and Biotechnology companies are increasingly required to gather concise knowledge of 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 of the development strategy. This is fundamental for both 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 endpoints with larger sample sizes.
ARENSIA offers:
- Dedicated highly experienced team with an exceptional reputation in performing sophisticated First-into-Patient trials
- A unique model of state-of-the-art research clinics in Eastern Europe specialized in performing Phase Ib/IIa/POC clinical trials, with proven fast industry-beating patient recruitment achievements/capabilities
- Tailored Regulatory Strategies
These approaches have greatly benefited our Sponsors as we have reduced timelines, and required resources considerably, facilitating the acceleration to PROOF OF CONCEPT.
ARENSIA has further reduced the 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´s research clinics 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.
