Since 1990, Amarin has been successfully performing clinical studies in volunteers and patients, mostly on the bioavailability-bioequivalence field.

Amarin is capable of performing the following tasks related to Phase I to Phase III, with competitive costs:

• Protocol Design & Development.
• Informed Consent and Case Report Form Development.
• Management & Coordination of the sites involved.
• Regulatory Presentations and Follow Up.
• Monitoring and Site Qualification Activities.
• Quality Policies and Standard Operating Procedures Development.
• Data Base Management.
• Statistical Analyses.
• Final Report Issuance and Presentations.

All these activities are timely conducted according internal quality policies and SOPs, with a full commitment to local regulations, involving Ethical Committees, Ministry of Health, Ministry of Justice (data protection) submissions, and international standards like current Good Clinical Practices guidelines, ICH recommendations, FDA/EMEA guidelines, Declaration of Helsinki, CIOMS, and WHO directives.

We have performed clinical studies for national and international companies such as Wyeth Ayerst (USA), Synthropharma Limited (Scotland), Helm Pharmaceuticals GmbH (Germany) and Laboratorios Beta S.A. (Argentina).