Your representation for Europe

As a European-based CRO with 25 years of experience in clinical research we are the ideal partner to act as a legal representative for clients from outside Europe. According to the Clinical Trials Directive 2001/20/EC all sponsors either need their own legal entity or a representative in Europe to deal with regulatory authorities in the member states. We maintain EU-wide operations covering everything from clinical proof to the preparation of study documents. Strategic thinking, long-term experience with regulatory authorities in the member states, and our lean processes management guarantee the fastest track to your clinical data package.

Our services for non-EU companies

  • Acting as legal representative vis-à-vis authorities during clinical evaluation
  • EU-wide representation and study conduct
  • Regulatory submissions for clinical studies in all EU countries
  • Providing updates about legislation within the European Union
  • Reporting of SAEs/SUSARs to ethics committees and to the European EudraVigilance database
  • Consulting with our network of clinicians, regulatory and legal specialists
  • Acting as SME status applicant according to Commission Recommendation 2003/361/EC
  • EU representative for clinical investigations of medical devices
  • Appropriate insurance coverage for all member states
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