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CRO Services
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/services related to Phase I to Phase III, with competitive costs:
  • Protocol Design (including CRF and Informed Consent).
  • Regulatory Presentations and Follow Up.
  • Qualification of the sites involved in the execution of the protocols.
  • Study Monitoring or Study Auditing.
  • Data Base Management and Statistical Analyses.
  • Final Report.
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 submissions, and international standards like current Good Clinical Practices guidelines, ICH recommendations, FDA/EMA guidelines, Declaration of Helsinki, CIOMS, and WHO directives.

We have performed clinical studies with the following products: Estradiol TDS, Estradiol-Norethisterone Acetate TDS, Diclofenac TDS, Diclofenac Gel, Risperidone TDS, Rivastigmine TDS, Scopolamine TDS, Phenytoin sodium tablets, Selegiline TDS and Fentanyl TDS.

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