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 legal representative for clients from outside Europe. According to the Clinical Trials directive 2001/20/EC all sponsors either need an own legal entity or a representative in Europe to deal with regulatory authorities in the member states. We maintain EU-wide operation all the way to clinical proof and preparation of study documents. Strategic thinking, long-lasting experience with regulatory authorities in the member states, and our lean processes management guarantees the fastest track to your clinical data package.

Our services for non-EU companies

  • Act as legal representative regarding 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 Ethic Commissions and to the European EudraVigilance database
  • Consulting with our network of clinicians, regulatory and legal specialists
  • Acting as SME status applicant according to the Commission Recommendation 2003/361/EC
  • EU representative for clinical investigations of medical devices
  • Appropriate insurances for the all member states
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