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Proof of concept trials

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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INTRODUCTION IN CLINICAL TRIALS

The medicines available today in pharmacies are the outcome of medical research. Medical research has tremendously evolved over the last 50 years, contributing through new therapies and innovative medicines to cure many diseases and therefore prolonging lifespans.

Researchers predict that every second child born today is likely to live beyond the age of 100 years, due to the progress of medical research!

Each medicinal product, before being sold in a pharmacy and being used for the treatment of countless diseases, goes through a long process of research, testing, efficacy confirmation, identification of possible side effects, and eventually being approved for marketing.

Clinical research adheres to very strict national and international regulations, which are carried out based on the ICH-GCP (International Conference of Harmonization - Good Clinical Practice) Guidelines and the Helsinki Declaration, adopted by the General Assembly of the World Medical Association.

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf

All the European states, USA, Canada, Japan and most countries throughout the world adhere to these international regulations in order to facilitate the progress of medical science for the good of mankind.

Clinical trials are conducted in many different locations such as hospitals, universities, medical practices, or medical clinics, all certified for research activities by the competent health authorities.

A clinical study may be single centre (taking place at one single centre/clinic, i.e. in one single country) or multicentre (taking place at multiple centres in several countries). Most clinical trials involving human volunteers are multicentre and are conducted simultaneously in European Union countries, the United States, Canada, Japan, the Russian Federation, Australia, New Zeeland, etc., whose volunteers contribute together to international clinical research.

Countries with a long-standing tradition in pharmaceutical clinical research are also the undisputed leaders regarding the number of clinical trials conducted per capita. The USA holds the first place in this respect, followed by European Union countries.

Good Clinical Practice (GCP) Guidelines are internationally accepted, ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve volunteer participation of human subjects to ensure:

  • Protection of study subjects’ rights, safety and well-being
  • Obtaining valid and reliable data in clinical trials
  • Improving the overall quality of clinical research
  • Mutual acceptance of the data by countries where clinical research projects are carried out

For additional information on clinical trials, please visit the websites of:

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